orabase and Dry-Eye-Syndromes

To evaluate the efficacy and safety of a nano-emulsion artificial tear (OM3) containing carboxymethylcellulose (CMC) and glycerin, flaxseed oil and castor oil, and three osmoprotectants (levocarnitine, erythritol, and trehalose) compared with an artificial tear (Refresh Optive Advanced [ROA]) containing the same ingredients with the exception of trehalose and flaxseed oil.. In this multicenter, double-masked, randomized, two-arm, parallel-group, 6-visit study (screening, baseline, and days 7, 30, 60, and 90), subjects with dry eye disease underwent an open-label, 7-day run-in with CMC 0.5% (Refresh Plus), before 1:1 randomization to OM3 or ROA for 90 days (both instilled ≥2 daily). Ocular Surface Disease Index (OSDI; primary endpoint change from baseline at day 90), tear film breakup time (TBUT), and ocular staining (combined/corneal/conjunctival) were assessed; change from baseline in these parameters was calculated at each timepoint. Treatment-related adverse events (AEs) were assessed at each visit.. Overall, 242 subjects were randomized (OM3, n = 120; ROA, n = 122). At day 90, significant improvements in OSDI, ocular staining and TBUT were evident in both treatment groups. Significant (P < 0.05) between-group differences in favor of OM3 were observed for combined ocular staining (all timepoints), corneal staining (day 90), and conjunctival staining (day 30). Treatment-related AEs were higher in the ROA (9.8%) versus OM3 (6.7%) group; blurred vision was among the most commonly reported AE (OM3 0% vs ROA 4.1%).. These findings support the application of OM3, a novel preservative-free, nano-emulsion tear formulation with trehalose and flaxseed oil, for the treatment of dry eye disease.

Topics: Carboxymethylcellulose Sodium; Dry Eye Syndromes; Humans; Linseed Oil; Lubricant Eye Drops; Ophthalmic Solutions; Tears

To evaluate the effects of a new lubricating, antioxidant solution (VisuEvo. Patients requiring cataract surgery with either healthy ocular surface or mild DED (tear break-up time, TBUT > 7, Schirmer I test > 15 mm/5 min) were enrolled in this multicenter, open-label, randomized, prospective study. Scheduled visits were 2 weeks before surgery (screening), day of surgery (V0), week 1 (V1), and 2 (V2) after surgery. VisuEvo. A total of 45 patients were included (group A, 23; group B, 22; age 74 ± 8 years). At the screening, TBUT was similar between the groups (group A, 8.5 ± 1.8 s; group B, 7.8 ± 0.7, p = 0.11). At the scheduled visits, TBUT increase vs screening visit was significantly higher in group A: +1.2 s at V0, +1.4 s at V1, and +1.9 s at V2 (p < 0.01). Also, OSDI was significantly lower in group A at V0, V1, and V2 (p < 0.027). After surgery, corneal staining was absent in 65-78% of group A compared with 54-59% in group B. The two groups did not show any significant differences of osmometry and the Schirmer I test.. The ocular surface was more protected and quickly restored from surgery when VisuEvo. ClinicalTrials.gov identifier, NCT03833908.

Topics: Aged; Carboxymethylcellulose Sodium; Cataract; Cataract Extraction; Dry Eye Syndromes; Female; Humans; Lubricant Eye Drops; Male; Middle Aged; Ophthalmology; Prospective Studies; Visual Analog Scale

To study the effects of xanthan gum eye drops on the ocular surface and conjunctival cytology of patients with mild-moderate dry eye.. This prospective, double-masked, controlled trial included 30 patients (age > 60 and Ocular Surface Disease Index score >12 and <33), divided into two groups of 15 subjects and treated with 0.2% xanthan gum eye drops (group 1) or 0.5% carboxymethylcellulose (group 2) qid. After a run-in period with saline qid, patients were evaluated by Ocular Surface Disease Index questionnaire, clinical assessment, and impression cytology at baseline (T0) and after 1 month (T1). For impression cytology, cellularity, cell-to-cell contacts, nucleus/cytoplasm ratio, chromatin aspect, goblet cells distribution, keratinization, and the presence of inflammatory cells were considered. Parameters were scored from 0 (no alterations) to 3 (evident alterations). For statistical analysis, Student's t-test, Wilcoxon rank-sum test, and Mann-Whitney U-test were used.. Clinically, after 1 month of treatment, group 1 showed an improvement of corneal stain (T0 = 1.1 ± 1.4; T1 = 0.5 ± 0.7; p = 0.03) and a reduction of Schirmer I test (T0 = 9.8 ± 6.1; T1 = 5.9 ± 4.1; p = 0.001). In group 2, no differences were found between T0 and T1 for all the clinical tests. For impression cytology, in group 1 cellularity (T0 = 0.6 ± 0.5; T1 = 0.3 ± 0.5; p = 0.05), chromatin aspect (T0 = 1.2 ± 0.4; T1 = 0.8 ± 0.5; p = 0.01), keratinization (T0 = 1 ± 0.7; T1 = 0.5 ± 0.5; p = 0.03), and total score (T0 = 5.8 ± 1.3; T1 = 3.6 ± 1.7; p = 0.003) were significantly ameliorated, while in group 2 only total score improved significantly (T0 = 5 ± 1.4; T1 = 4.3 ± 1.5; p = 0.01). The comparison between groups showed significant amelioration for keratinization in group 1 at T1 (p = 0.02).. The treatment with xanthan gum, a molecule with anti-oxidant and mucoadhesive properties, ameliorated conjunctival epithelium of mild-moderate dry eye patients better than carboxymethylcellulose.

Topics: Administration, Ophthalmic; Aged; Aged, 80 and over; Carboxymethylcellulose Sodium; Conjunctiva; Double-Blind Method; Dry Eye Syndromes; Epithelial Cells; Female; Food Additives; Humans; Male; Middle Aged; Ophthalmic Solutions; Polysaccharides, Bacterial; Prospective Studies; Surveys and Questionnaires

In a randomized, controlled clinical trial, two lubricant artificial tear formulations with enhanced viscosity were compared: an investigational product at the time, containing carboxymethylcellulose 1.0% and glycerin 0.9% (CMC-GLY) with osmoprotectants, and a standard formula containing carboxymethylcellulose 1.0% alone (CMC).. A total of 188 patients (94 CMC-GLY, 94 CMC) were enrolled. The severe subgroup had 67 CMC-GLY and 65 CMC patients. OSDI scores progressively improved and were similar at day 30 between treatment groups. At day 7, only the CMC-GLY group demonstrated significant improvements from baseline in OSDI score (all patients p < 0.001, severe p < 0.001), corneal staining (p = 0.004), and TBUT (p < 0.001). Between-group dose frequency for CMC-GLY was lower at day 7 (p = 0.031). Other efficacy results were similar between groups. The most commonly reported adverse event in both groups was blurred vision.. Overall, the CMC-GLY artificial tear formulation was as effective as the CMC formulation. CMC-GLY demonstrated improvements at an earlier stage (day 7). Both artificial tear formulations were safe and well tolerated, with no treatment-related serious adverse events. These results support the use of the CMC-GLY artificial tear formulation as an effective treatment to reduce the symptoms and signs of dry eye disease.

Topics: Administration, Ophthalmic; Adult; Aged; Carboxymethylcellulose Sodium; Double-Blind Method; Drug Combinations; Dry Eye Syndromes; Female; Glycerol; Humans; Lubricant Eye Drops; Male; Middle Aged; Ophthalmic Solutions; Tears; Treatment Outcome; Viscosity

Dry eye is defined by a tear film instability resulting in variable but systematic fluctuations in the quality of vision. Variability in optical quality can be demonstrated using a double pass aberrometer such as the OQAS (Optical Quality Analyzing System, Visiometrics). The goal of this work is to compare fluctuations in objective quality of vision measured by OQAS between treatment with normal saline eye drops and treatment with carmellose 0.5% and hyaluronic acid 0.1% (Optive Fusion [OF], Allergan) in patients with moderate dry eye syndrome. Optical quality was measured by evaluating the variations in the Optical Scattering Index (OSI) over 20seconds using the OQAS. Inclusion criteria were dry eye syndrome with an Ocular Surface Disease Index (OSDI) score>23 treated only with artificial tears. The patients were their own controls: OF in one eye and normal saline in the fellow eye. The choice of the subject eye and control eye was determined in a randomized fashion. OSI variations were measured in each eye before instillation, 5minutes and 2hours after instillation. The primary endpoint was OSI fluctuation over 20seconds of measurement. Secondary endpoints were the number of blinks and patient's preference (preferred eye). Preliminary results were obtained on 19 patients. Average OSDI score was 36.8. Visual acuity was 10/10 with no significant difference between the two eyes. Prior to instillation, there was no significant difference between "normal saline" and "OF" eyes in terms of OSI, OSI variability or number of blinks. In the normal saline eye, there was no significant variation in mean OSI, OSI variability, OSI slope, or number of blinks. However, in the "OF" eye, there was a significant variation between initial and 2-hour OSI variability (0.363 versus 0.204; P<0.05), the average slope of OSI (0.04 versus 0.01; P<0.05) and the number of blinks (4.2 versus 2.8; P<0.05). Sixty-five percent of patients preferred the OF eye, 24% did not have a preference, and 11% preferred the normal saline eye. Objective quality of vision measured by OQAS is an interesting parameter for evaluating the effectiveness of a lacrimal substitute. The purpose of artificial tears is, among other things, to provide comfort and a reduction of dry eye symptoms such as poor quality of vision. This study demonstrates that 0.5% carmellose and 0.1% hyaluronic acid allowed better stabilization of the tear film and thus a significant improvement in the quality of vision compared to

Topics: Aberrometry; Aged; Aged, 80 and over; Blinking; Carboxymethylcellulose Sodium; Dry Eye Syndromes; Female; Humans; Hyaluronic Acid; Light; Lubricant Eye Drops; Male; Middle Aged; Ophthalmic Solutions; Pilot Projects; Prospective Studies; Scattering, Radiation; Severity of Illness Index; Sodium Chloride; Tears; Visual Acuity

PurposeTo assess the safety and efficacy of an eye drop combining osmoprotectants, carboxymethylcellulose and hyaluronic acid (O/CMC/HA) in reducing symptomatic, moderate to severe dry eye, compared with HA.MethodsIn this investigator-masked, randomised study, patients instilled 1-2 drops/eye of O/CMC/HA or HA (2-6 times/day) for 3 months. Primary endpoint: mean change in Global Ocular Staining Score (GOSS) from baseline at day 35. Noninferiority of O/CMC/HA was tested in the per-protocol population; if achieved, superiority was tested in the intent-to-treat population. Secondary efficacy endpoints: mean change from baseline in GOSS, Ocular Surface Disease Index (OSDI), Schirmer score, tear break-up time (TBUT), corneal/conjunctival staining, conjunctival hyperaemia, symptoms, and patient/investigator assessments.ResultsBaseline characteristics were comparable between groups (n=40 each). O/CMC/HA was noninferior (and not superior) to HA based on similar GOSS reductions from baseline at day 35 and month 3 in both groups (P=0.778, day 35, per-protocol population). Overall, O/CMC/HA and HA provided similar reductions in OSDI, Schirmer score, TBUT, corneal staining and hyperaemia from baseline at 35 days (P≥0.155). More patients reported less severe stinging/burning, sandiness/grittiness, and painful/sore eyes at month 3 with O/CMC/HA (P≤0.039), and more rated the dropper bottle easy to use (87.5%), compared with HA (46.2%; P=0.002). Other patient and investigator assessments were similar between groups. O/CMC/HA and HA were well tolerated.ConclusionsO/CMC/HA is noninferior to HA in improving objective signs of dry eye, with potential advantages for subjective symptoms and patient acceptance.

Topics: Carboxymethylcellulose Sodium; Dose-Response Relationship, Drug; Drug Administration Schedule; Dry Eye Syndromes; Female; Humans; Hyaluronic Acid; Male; Middle Aged; Ophthalmic Solutions; Osmosis; Severity of Illness Index; Tears; Treatment Outcome; Viscosupplements

For patients who experience dry eye after phacoemulsification, vision and quality of life can significantly deteriorate. In this study, the efficacy and safety of carboxymethylcellulose sodium (CMC) 1% ophthalmic solution combined with conventional therapy in treating dry eye signs and symptoms after phacoemulsification were evaluated.. In this prospective, multicenter, open-label, controlled study, 180 patients with age-related cataract were randomized to treatment with conventional therapy plus CMC 1% (n = 90) or to conventional therapy only (control group, n = 90) after phacoemulsification and intraocular lens implantation. Tear breakup time (TBUT), the Schirmer test with anesthesia, and fluorescein and lissamine green staining were performed. The Ocular Surface Disease Index (OSDI) questionnaire and a patient subjective symptom evaluation were administered preoperatively (baseline) and postoperatively at 7 and 30 days.. TBUT was significantly longer in the treatment group compared with the control group at day 7 (8.5 ± 5.5 versus 6.6 ± 3.8 s; P = 0.0475) and day 30 (9.0 ± 5.9 versus 6.7 ± 4.8 s; P = 0.0258) after surgery. Compared with baseline, TBUT significantly increased in patients in the treatment group (P < 0.001 at both day 7 and day 30) with a presurgical diagnosis of dry eye, but significantly decreased in patients in the control group (P < 0.02 at both day 7 and day 30) with no prior diagnosis of dry eye. Fluorescein and lissamine staining, OSDI questionnaire and subjective symptom scores all improved from baseline, with no significant differences between the two groups. No significant differences in tolerability and safety were observed between the group receiving CMC and conventional therapy, and those receiving conventional therapy only.. Treatment with CMC 1% can provide significant improvement in tear film stability after phacoemulsification for age-related cataract.. ClinicalTrials.gov identifier NCT02028754 (Date of registration: Jan. 6, 2014).

Topics: Aged; Aged, 80 and over; Carboxymethylcellulose Sodium; Dry Eye Syndromes; Female; Follow-Up Studies; Humans; Male; Middle Aged; Ophthalmic Solutions; Phacoemulsification; Prospective Studies; Quality of Life; Surveys and Questionnaires

To evaluate the efficacy and safety of using sodium hyaluronate 0.1% and carboxymethylcellulose 0.5% artificial tears for ocular discomfort and tear-film stability in eyes after cataract surgery.. Twenty ophthalmic centers in Italy.. Prospective randomized case series.. This study enrolled patients scheduled for unilateral cataract surgery. After surgery, patients received artificial tears and a topical steroid-antibiotic (study group) or topical steroid-antibiotic alone (control group) and were assessed postoperatively at 1 and 5 weeks. Outcome measures were tear breakup time (TBUT), ocular surface disease index (OSDI), frequency of dry-eye symptoms evaluated using a visual analog scale (VAS), and corneal fluorescein staining.. The study comprised 282 patients. At 5 weeks, the mean TBUT was statistically significantly higher in the study group than in the control group (P = .0003). The mean OSDI score statistically significantly improved in both groups from 1 to 5 weeks (P < .0001 for both groups); however, there was no statistically significant difference between the groups at these timepoints. The artificial tears statistically significantly improved VAS-assessed dry-eye symptoms in the study group compared with the control group at 5 weeks (P < .001). The mean corneal fluorescein staining was significantly reduced in the study group compared with the control group at 5 weeks (P = .002 versus P = .05, respectively). No treatment-related adverse events were reported.. Sodium hyaluronate 0.1% and carboxymethylcellulose 0.5% ophthalmic solution was effective and well tolerated in reducing dry-eye disease symptoms and improving the clinical outcome after cataract surgery.. No author has a financial or proprietary interest in any material or method mentioned.

Topics: Aged; Carboxymethylcellulose Sodium; Drug Combinations; Dry Eye Syndromes; Female; Fluorophotometry; Humans; Hyaluronic Acid; Lens Implantation, Intraocular; Lubricant Eye Drops; Male; Ophthalmic Solutions; Phacoemulsification; Prospective Studies; Tears; Viscosupplements; Visual Analog Scale

Dry eye is often characterized by increased tear evaporation due to poor tear film quality, especially of the lipid component of the tear film. Using an environmental chamber to induce environmental stress, this study compared the effect of three lubricant eye drops on various aspects of tear physiology in a crossover design (evaporation was the principal outcome measure).. Three eye drop formulas were tested: 0.5% carmellose sodium (Drop C), 0.5% carmellose sodium with added lipid (Drop C-L) and 1.0% glycerine with added lipid (Drop G-L). Nineteen control and 18 dry eye subjects used each product for 2 weeks, three times per day, in a random order, with a minimum 1-week washout between treatment periods. Tear evaporation, break up time, osmolarity, tear structure (by interferometry) and patient symptoms were assessed with the subjects adapted for 10 min in an environmental chamber controlled at 20% relative humidity and 22 °C. The treatment effects were analyzed using general linear model repeated measures analyses of variance.. In dry eye subjects, evaporation, break up time, osmolarity and symptoms improved for all formulas (p < 0.05). Normal subjects showed some improvements: evaporation with C-L, osmolarity with C and symptoms with C-L and G-L. Change in evaporation was greater for both C-L and G-L versus C (p < 0.05), and there was a trend for C-L to reduce evaporation more than G-L (p < 0.11). There were no significant treatment effects on tear film structure.. Overall, the eye drop formula containing both carmellose sodium and lipid (C-L) produced a greater treatment effect on tear evaporation than the other formulations containing only one of these ingredients. This study also demonstrates the utility of a controlled environmental chamber in showing the difference in performance between dry eye treatments.

Topics: Carboxymethylcellulose Sodium; Cross-Over Studies; Double-Blind Method; Drug Carriers; Dry Eye Syndromes; Environmental Exposure; Glycerol; Humans; Humidity; Interferometry; Ophthalmic Solutions; Patient Satisfaction; Stress, Physiological; Tears; Treatment Outcome

To assess the ability of a noninvasive, objective, multimodal system to compare the efficacy and optical quality of 4 different groups of 5 over-the-counter tear drops.. Wavefront sensing and optical coherence tomography (OCT) were used to objectively assess visual quality and tear volume, respectively, after the over-the-counter tear drops [2 polyethylene glycol (PEG)-400, 1 carboxymethyl cellulose (CMC), 1 polyvinyl alcohol/PEG-400 (PVA), and 1 glycerine/polysorbate-80] were administered to 23 patients with aqueous-deficient dry eye in a randomized, controlled, double-masked trial. Measurements at each of the 5 visits were taken from both eyes at baseline and 5, 20, and 40 minutes after drop instillation.. At 5 minutes after drop instillation, the 2 PEG drops showed significant worsening of visual quality (-128.87%, P = 0.001) compared with CMC, PVA, and glycerine drops. Tear volume was elevated significantly with PEG and CMC drops at 5 minutes (+33.2%, P = 0.002; +29.9%, P < 0.001) compared with the other groups. Subjects with a Schirmer score of less than 5 mm at 5 minutes showed improvement in visual quality with PEG drops, whereas those with a fluorescein staining score of 1 to 2 showed improvement with both PEG and CMC drops. A trend toward decreasing visual quality with increasing tear meniscus was noted.. Noninvasive multimodal imaging has the potential to evaluate tear dynamics and the efficacy of artificial tears objectively. Certain artificial tear components and the temporary increase in tear volume after instillation of artificial tears may contribute to transient reduction of visual quality.

Topics: Adult; Carboxymethylcellulose Sodium; Corneal Topography; Double-Blind Method; Drug Combinations; Dry Eye Syndromes; Female; Glycerol; Humans; Male; Nonprescription Drugs; Ophthalmic Solutions; Polyethylene Glycols; Polysorbates; Polyvinyl Alcohol; Tears; Tomography, Optical Coherence; Visual Acuity

We compared the efficacy and safety of sodium hyaluronate (SH) and carboxymethylcellulose (CMC) in treating mild to moderate dry eye.. Sixty-seven patients with mild to moderate dry eye were enrolled in this prospective, randomized, blinded study. They were treated 6 times a day with preservative-free unit dose formula eyedrops containing 0.1% SH or 0.5% CMC for 8 weeks. Corneal and conjunctival staining with fluorescein, tear film breakup time, subjective symptoms, and adverse reactions were assessed at baseline, 4 weeks, and 8 weeks after treatment initiation.. Thirty-two patients were randomly assigned to the SH group and 33 were randomly assigned to the CMC group. Both the SH and CMC groups showed statistically significant improvements in corneal and conjunctival staining sum scores, tear film breakup time, and dry eye symptom score at 4 and 8 weeks after treatment initiation. However, there were no statistically significant differences in any of the indices between the 2 treatment groups. There were no significant adverse reactions observed during follow-up.. The efficacies of SH and CMC were equivalent in treating mild to moderate dry eye. SH and CMC preservative-free artificial tear formulations appropriately manage dry eye sign and symptoms and show safety and efficacy when frequently administered in a unit dose formula.

Topics: Adult; Aged; Carboxymethylcellulose Sodium; Conjunctiva; Cornea; Dry Eye Syndromes; Female; Humans; Hyaluronic Acid; Male; Middle Aged; Ophthalmic Solutions; Severity of Illness Index; Single-Blind Method; Staining and Labeling; Treatment Outcome; Young Adult

To compare the effects of Viscofresh 0.5% (carmellose sodium 0. 5%) versus Lubristil (sodium hyaluronate 0.15%) in dry eye syndrome and to study the influence of these two treatments on the expression of various inflammatory markers by flow cytometry in impression cytology specimens.. In this randomized, masked-observer, parallel group, single-center study, 15 patients with dry eye syndrome were randomized to sodium carmellose 0.5% or sodium hyaluronate 0.15% 1-month treatment after a 1-week washout period. Corneal staining with flurescein, breakup time, Schirmer 1 test with anesthesia (Jones test), and tear clearance were assessed. Besides, conjunctival impression cytology was performed to investigate inflammatory markers (CD3, CD11b, and HLA-DR) using flow cytometry.. Carmellose group shows statistical improvement compared with the hyaluronate group in breakup time, corneal staining, and HLA-DR. The two other inflammatory markers had also a tendency for a decreased expression in both groups, with no statistical significance. There were neither visual acuity loss nor other complications related to treatment.. Both artificial tears improve dry eye signs and symptoms and inflammatory markers expression, with significant better results in carmellose group.

Topics: Adult; Aged; Biomarkers; Carboxymethylcellulose Sodium; CD11b Antigen; CD3 Complex; Cornea; Double-Blind Method; Dry Eye Syndromes; Female; Flow Cytometry; Fluorescein; HLA-DR Antigens; Humans; Hyaluronic Acid; Middle Aged; Ophthalmic Solutions; Prognosis; Staining and Labeling; Tears

To investigate the influence of three lubricants of varying viscosity, on postinsertion and 6 h comfort with contact lens wear.. Comfort and associated symptoms of dryness were assessed in 15 experienced contact lens wearers. Subjects wore a low Dk lens in one eye and a silicone hydrogel in the other and participated in four separate trials involving no lubricant (baseline), saline, and two commercially available lubricants of differing viscosity. The in-eye lubricants were used immediately following lens insertion and every 2 h postinsertion for a 6 h wear period.. Postlens insertion comfort was significantly better for both lens types when lubricants or saline were used compared with no lubricant use. After 6 h lens wear, comfort was influenced by lens type and not by in-eye lubricant or saline use. Also after 6 h lens wear, less dryness sensation was reported for silicone hydrogel lenses when using lubricants but not saline.. Although lubricant use does help reduce dryness symptoms with silicone hydrogel lens wear, there appears to be minimal longer-term benefit to comfort. Furthermore, increased lubricant viscosity did not lead to improved longer-term comfort.

Topics: Adult; Carboxymethylcellulose Sodium; Contact Lenses, Hydrophilic; Cross-Over Studies; Dry Eye Syndromes; Female; Humans; Hydrogels; Male; Ophthalmic Solutions; Patient Satisfaction; Polyvinyl Alcohol; Prosthesis Fitting; Silicones; Sodium Chloride; Viscosity

The present study aimed to compare the clinical efficacy of a 0.4% carbomer gel and 1% carboxymethyl cellulose (CMC) containing artificial tears in treatment of dry eye patients. Sixty subjects with mean age of 45.89 years who had symptoms and signs of dry eye were enrolled in this prospective, investigator-masked and stratified random sampling study. The subjects were divided into two parallel groups with 30 subjects (60 eyes) in each group. One group received carbomer gel, and the other group received 1% CMC containing artificial tears. Subjects received the drops 3 to 4 times or more per day for 3 months. At the first visit time, the precorneal residence time of these two drops was measured. The efficacy was assessed by comparing the subjective symptoms (ocular dryness, foreign body sensation, burning sensation and pain), and the objective test results of tears breakup time, Schirmer's test and corneal fluorescein staining prior to the study and after the treatment. As a result, the ocular residence time of carbomer gel was significantly longer than that of 1% CMC (P<0.001). Most of the primary subjective symptoms and objective test results were improved after treatment in both carbomer gel group and 1% CMC group. As to the improvement of each symptom and objective test result, carbomer gel was more effective than 1% CMC group (P<0.01). In conclusion, carbomer gel had longer precorneal residence time and was more effective than 1% CMC in the treatment of patients with dry eyes.

Topics: Acrylic Resins; Adult; Carboxymethylcellulose Sodium; Dry Eye Syndromes; Female; Gels; Humans; Male; Middle Aged; Ophthalmic Solutions; Prospective Studies

We report the results of 3 studies conducted to evaluate the performance of a 1.0% carboxymethylcellulose (CMC) mid-viscosity artificial tear compared to currently marketed low-viscosity tears.. First, a single-center, double-masked, randomized, crossover study was performed to compare the effect on the Ocular Protection Index (OPI) of the mid-viscosity tear compared to low-viscosity tears in 39 subjects with mild to moderate dry eye. Second, a 1-month, 2-arm, parallel, randomized double-masked clinical study assessed objective signs and subjective symptoms of dry eye in 103 subjects with mild to moderate dry eye. Third, in a 1-month home-use test, 465 artificial tear users compared the mid-viscosity tear or a current low-viscosity tear to their current artificial tear.. The OPI study showed prolonged tear breakup time and improved OPI for at least 20 minutes after instillation of the mid-viscosity tear. The low-viscosity tears showed improvements for 5 to 10 minutes. The 1-month clinical study showed a significant reduction in staining and dry eye symptoms after 1 week of treatment, with a further reduction in staining after 1 month in the mid-viscosity group. Subjects provided more reports of blur with the mid-viscosity tear than with a low-viscosity tear, but equivalent overall acceptability. The home use test showed general acceptability of the mid-viscosity tear, including more subjects indicating that it was needed less frequently than their prior low-viscosity tear.. This 1% CMC mid-viscosity tear showed protection of the ocular surface after instillation and significant reduction in signs and symptoms of dry eye. Improvements were greater than with low-viscosity tears. The mid-viscosity artificial tear was rated well in comfort, duration of benefit, and general acceptability.

Topics: Carboxymethylcellulose Sodium; Cross-Over Studies; Double-Blind Method; Dry Eye Syndromes; Female; Humans; Hypromellose Derivatives; Male; Methylcellulose; Middle Aged; Ophthalmic Solutions; Surveys and Questionnaires; Tears; Viscosity

To report the performance of an artificial tear containing propylene glycol and polyethylene glycol as active demulcents with hydroxypropyl-guar as a gelling agent (Systane Lubricant Eye Drops; Alcon, Fort Worth, TX) and compare it with that of 2 artificial tears containing carboxymethylcellulose (Refresh Tears and Refresh Endura Lubricant Eye Drops; Allergan, Irvine, CA).. This was a single-center, 3-visit, randomized, double-masked crossover study that evaluated the effect of Systane versus Refresh Tears and Refresh Endura using tear film breakup time (TFBUT) and ocular protection index (OPI) in subjects with dry eye (n = 50). TFBUT values (5, 10, 15, 20, 30, 45, and 60 minutes after instillation) divided by interblink interval (IBI) yielded OPI scores.. Systane significantly improved TFBUT at 5, 10, 15, 20, and 60 minutes versus Refresh Tears and at 5, 10, 15, 20, and 30 minutes versus Refresh Endura. Systane OPI scores were significantly higher than Refresh Tears at 15 and 30 minutes and than Refresh Endura at 5 minutes.. This study suggests that Systane Lubricant Eye Drops was more effective than Refresh Tears at prolonging TFBUT up to 20 minutes after instillation and more effective than Refresh Endura at prolonging TFBUT up to 30 minutes after instillation. These data show that Systane is an effective first-line dry eye therapy and a superior ocular surface protector compared with Refresh Endura and Refresh Tears in the sample test population.

Topics: Adult; Aged; Aged, 80 and over; Blinking; Carboxymethylcellulose Sodium; Cross-Over Studies; Double-Blind Method; Drug Evaluation; Dry Eye Syndromes; Female; Humans; Lubricants; Male; Middle Aged; Ophthalmic Solutions; Polyethylene Glycols; Polysaccharides; Propylene Glycol; Tears; Time Factors

To assess the efficacy of sodium carboxymethylcellulose in the treatment of dry eye.. We carried out a prospective, randomized, masked-observer, control/problem group, single-center clinical assay during a period of 12 months in 19 patients that presented mild or moderate forms of dry eye. Patients were clinically evaluated each 3 months and treated with a 0.5% isotonic solution of sodium carboxymethylcellulose (CMC) or balanced salt solution. Subjective symptoms, functional tests and conjunctival impression cytology were performed according preexistent schedule study visits. To compare data between groups chi squared (chi2) analysis was applied.. We observed a significant (p<0.05) decrease in the frequency of subjective symptoms and a significant (p<0.05) improvement of tearfilm interface stability after CMC treatment. There was a tendency to improve the degree of corneal surface wettability and the tearfilm integrity with higher percentage improvements in the CMC group compared to controls. Improved baseline values in at least one of the objective functional tests carried out (p<0.05) was also observed in an elevated percentage of patients in the CMC group (83.3%) compared with controls (34%). Furthermore, we observed a tendency to diminish the frequency of associated subjective symptoms after treatment. Conjunctival impression cytology did not provide significant differences related with therapeutic response.. The results show a significant beneficial effect of CMC to improve clinical parameters in mild and moderate forms of dry eye.

Topics: Adult; Aged; Carboxymethylcellulose Sodium; Dry Eye Syndromes; Female; Humans; Male; Middle Aged; Prospective Studies

To compare the effectiveness of 1.0% carboxymethylcellulose (CMC) (Refresh Liquigel, Allergan, Inc., Irvine, CA) and propylene glycol/polyethylene glycol 400 (PG-HPG) (Systane, Alcon, Fort Worth, TX) in providing relief of dry eye symptoms and signs.. To evaluate patient comfort and drop preference, patients were given CMC in one eye and PG-HPG in the other. Five minutes after the initial drop application, patients were questioned on overall preference and comfort, as measured by stickiness, blurring, and soothing. Patients were then randomized to receive CMC or PG-HPG in both eyes for 1 week. Fluorescein staining was evaluated at baseline and week 1.. Of patients with a preference, more patients preferred CMC than PG-HPG. Thirty-six percent preferred CMC, and 24% preferred PG-HPG. More (35%) patients found CMC to be more soothing than PG-HPG (22%). After 1 week of treatment, eyes treated with CMC consistently showed less ocular surface staining than did eyes treated with PG-HPG. Mean corneal staining score in the inferior region was significantly lower in the CMC group than in the PG-HPG group (P = 0.008) at week 1. CMC provided a statistically significant decrease in mean corneal inferior staining (P < 0.001), whereas the PG-HPG group (P = 0.185) had no significant change. In the temporal conjunctival region, CMC provided a significantly lower mean staining score than PG-HPG after 1 week of treatment (P = 0.005).. Patients found CMC to be more comfortable than PG-HPG. After 1 week of use, CMC provided greater relief of dry eye signs and symptoms than PG-HPG.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Carboxymethylcellulose Sodium; Conjunctiva; Cornea; Drug Combinations; Dry Eye Syndromes; Humans; Middle Aged; Ophthalmic Solutions; Patient Satisfaction; Pharmaceutical Vehicles; Polyethylene Glycols; Propylene Glycol; Surface-Active Agents; Treatment Outcome; Viscosity

Sodium hyaluronate (SH) is used in patients with dry eye. We evaluated the efficacy and safety of SH and carboxymethylcellulose (CMC) in the treatment of dry eye syndrome with superficial keratitis.. A total of 22 patients with moderate dry eye and superficial keratitis were enrolled in a prospective, randomised, masked-observer, parallel-group, single-centre study. Patients were randomly assigned to a 0.18% SH or 1% CMC solution for a 2-month period. In addition to the commonly assessed parameters in patients with dry eye (among others symptoms and corneal staining with fluorescein), flow cytometry analysis of CD44, HLA DR expressions in impression cytology was investigated as a potential efficacy parameter.. Both treatments improved the symptoms and ocular surface and were well tolerated. SH significantly (p<0.05) decreased CD44 values compared with CMC. Comfort was significantly (P<0.05) better in the SH group than that in the CMC group throughout the study. Recovery in keratitis (type, extent and depth) and symptoms were faster in the SH group than in the CMC group. Blurred vision was reported by patients in the CMC group only.. SH was well tolerated and tended to show a faster efficacy than did the CMC-based formulation in patients with moderate dry eye and superficial keratitis. SH could therefore advantageously be prescribed from the early stages of dry eye disease. This study also showed that flow cytometry in impression cytology specimens is a reliable tool for exploring the ocular surface at the epithelial level and that CD44, in addition to HLA DR, could be an interesting endpoint for future trials in dry eye syndrome with products based on SH.

Topics: Aged; Carboxymethylcellulose Sodium; Conjunctiva; Cornea; Corneal Topography; Dose-Response Relationship, Drug; Dry Eye Syndromes; Female; Flow Cytometry; Fluorescein; Fluorescent Dyes; Follow-Up Studies; Humans; Hyaluronic Acid; Keratitis; Male; Middle Aged; Ophthalmic Solutions; Prospective Studies; Severity of Illness Index; Single-Blind Method; Treatment Outcome; Viscosupplements

To study the effect of commonly used preservative free artificial tear, carboxymethylcellulose (CMC) 0.5% (Refresh Plus, Allergan, Irvine, California) on visual acuity in symptomatic dry eye (SDE) and asymptomatic dry eye (ADE) patients.. Nonrandomized prospective clinical trial.. Prospective study involving 20 patients (40 eyes) with SDE and 20 patients (40 eyes) with ADE, all 40 years and older, were recruited from a clinic setting over a 1-month period. Distance visual acuity was measured by the Early Treatment of Diabetic Retinopathy Study (ETDRS) vision chart and near visual acuity was measured by the Lighthouse Near Vision chart before and 30 seconds after instillation of one drop of CMC. Distance and near visual acuity was measured both with and without correction. The duration of action of CMC was measured at 1-minute intervals until the patient's visual acuity returned to pretear level.. In both SDE and ADE groups, uncorrected and corrected near and distance vision showed a statistically significant improvement after the use of CMC (P < .05). There was no statistically significant difference in improvement between the SDE and ADE groups in all categories (P values > .05). The mean duration of improvement of vision was 2.93 minutes in the SDE group and 3.70 minutes in the ADE group (P = .036).. CMC 0.5% provides a temporary yet significant improvement in the visual acuity of SDE and ADE patients. The effect of artificial tears on visual acuity may be of diagnostic value in detecting ocular surface abnormality in symptomatic and asymptomatic patients.

Topics: Aged; Carboxymethylcellulose Sodium; Dry Eye Syndromes; Female; Humans; Male; Middle Aged; Ophthalmic Solutions; Preservatives, Pharmaceutical; Prospective Studies; Tears; Visual Acuity

To evaluate the efficacy of a new lubricant eye drop containing polyethylene glycol 400 and propylene glycol demulcents with hydroxypropyl-guar as a gelling agent (Test Product) to a system with carboxymethylcellulose (Control Product) for reducing dry eye signs and symptoms.. Eighty-seven dry eye volunteers were enrolled at seven sites for this six-week, concurrently controlled, double-masked clinical study.. The Test Product significantly reduced conjunctival staining (p = 0.025) and temporal corneal staining (p = 0.024) compared to the Control. The Test Product also significantly reduced symptoms of dryness in the morning and evening, compared to the Control (p = 0.015 and p = 0.023, respectively). Subjects in the Test treatment group reported lower frequencies of foreign body sensation and felt their eyes were "refreshed longer" compared to those in the Control group (p = 0.033 and p = 0.037, respectively).. The Test Product was more effective at reducing both the signs and symptoms of dry eye compared to the carboxymethylcellulose containing Control.

Topics: Carboxymethylcellulose Sodium; Conjunctiva; Cornea; Double-Blind Method; Drug Evaluation; Drug Therapy, Combination; Dry Eye Syndromes; Female; Galactans; Gels; Humans; Lubrication; Male; Mannans; Middle Aged; Ophthalmic Solutions; Plant Gums; Polyethylene Glycols; Preservatives, Pharmaceutical; Propylene Glycol; Safety; Treatment Outcome

Aim of this study was to compare the efficacy of sodium hyaluronate (SH) and carboxymethyl cellulose (CMC) eye drops in treating mild to moderate dry eye disease in terms of relief of symptoms, mean change in tear film breakup time, Schirmer's test, and impression cytology of conjunctiva from baseline.. An observational study was carried out during a 2-year period in our tertiary referral hospital. The study consisted of 60 patients randomly allotted to two groups to receive SH and CMC eye drops for an 8-week period. Ocular surface disease index, tear film breakup time, and Schirmer's test were performed at baseline visit and 4 and 8 weeks of treatment, and impression cytology of conjunctiva was performed at baseline and 8 weeks.. Significant improvement in patient symptoms, tear film breakup time, and Schirmer's test from baseline was seen in both SH and CMC groups at 8 weeks posttreatment, whereas impression cytology of conjunctiva in both groups did not show significant improvement at 8 weeks of treatment. Data analysis using unpaired t-test showed comparable results.. Both CMC and SH demonstrated equal efficacy in treating mild to moderate dry eye disease.

Topics: Carboxymethylcellulose Sodium; Dry Eye Syndromes; Humans; Hyaluronic Acid; Ophthalmic Solutions; Tears; Treatment Outcome

An important mechanism involved in dry eye (DE) is the association between tear hyperosmolarity and inflammation severity. Inflammation in DE might be mediated by the NLRP3 inflammasome, which activated by exposure to reactive oxygen species (ROS). A combination of carboxymethylcellulose (CMC) and α-melanocyte stimulating hormone (α-MSH) may influence DE through this mechanism, thus avoiding defects of signal drug. In this study, we assessed whether treatment comprising CMC combined with α-MSH could ameliorate ocular surface function; we found that it promoted tear secretion, reduced the density of fluorescein sodium staining, enhanced the number of conjunctival goblet cells, and reduced the number of corneal apoptotic cells. Investigation of the underlying mechanism suggested that the synergistic effect of combined treatment alleviated DE inflammation through reduction of ROS level and inhibition of the NLRP3 inflammasome in human corneal epithelial cells. These findings indicate that combined CMC + α-MSH treatment could ameliorate lesions and restore ocular surface function in patients with DE through reduction of ROS level and inhibition of NLRP3 signalling.

Topics: alpha-MSH; Animals; Apoptosis; Carboxymethylcellulose Sodium; Cell Line; Conjunctiva; Cornea; Disease Models, Animal; Dry Eye Syndromes; Epithelial Cells; Female; Goblet Cells; Humans; Inflammasomes; NLR Family, Pyrin Domain-Containing 3 Protein; Rats; Rats, Wistar; Reactive Oxygen Species; Scopolamine; Signal Transduction; Tears

This study aimed to investigate the tear ferning pattern and chemical elements of the tear film of camel tears compared with human tears and Refresh Plus eye lubricant. Refresh Plus was used as a control because it provides a healthy ferning pattern, due to the presence of an optimum ratio of carboxymethylcellulose (CMC) sodium and electrolytes. The main research focus is elucidating the viability of camel tear film in the dry, harsh environment of the desert.. The tears were collected from five camels, five male desert workers (20-25 years old) at a small village located 100 km from Riyadh, Saudi Arabia, and five male subjects (20-25 years old) from Riyadh. A small drop (1 μl) of tears was dried on a glass slide and observed under a light (Olympus BX1) and scanning electron microscope (Inspect S50, Field Electron and Ion Company [FEI]). Energy-dispersive X-ray spectroscopy (EDS) of the tear film and Refresh Plus were investigated with a JEOL 1400 scanning transmission electron microscope.. The camel tear film pattern was surrounded by thick, peripheral, homogenous layers containing small oily droplets, particles, and tiny branches in the tear ferning. The tear ferning of the camel was grade 0-1, whereas the tear ferning of human tears and Refresh Plus was grade 1-2. The mass percentage of chloride was highest in the camel tears. The mass percentage of potassium in the camel tears was greater than that in the human tears, but it was less than that in the Refresh Plus lubricant.. Camel tears exhibit a better quality than human tears and Refresh Plus lubricant do. The presence of oily droplet-like structures at the periphery of tear ferning suggests that camel tear film may have a higher quality and quantity of minerals and lubricants, which may help the animal to avoid eye dryness. Future work is required to investigate the identification of the elements present in the peripheral and central part of the tear ferning.

Topics: Adult; Animals; Camelus; Carboxymethylcellulose Sodium; Cations, Monovalent; Chlorides; Dry Eye Syndromes; Electrolytes; Humans; Lubricant Eye Drops; Male; Microscopy; Potassium; Spectrometry, X-Ray Emission; Tears

Topics: Animals; Carboxymethylcellulose Sodium; Cornea; Disease Models, Animal; Dry Eye Syndromes; Glycerol; Hyaluronic Acid; Lubricant Eye Drops; Preservatives, Pharmaceutical; Rabbits; Wound Healing

Dry eye disease is a major public health problem that affects millions of people worldwide. It is presently treated with artificial tear and anti-inflammatory eye drops that are generally administered several times a day and may have limited therapeutic efficacy. To improve convenience and efficacy, a dexamethasone (Dex) loaded nanowafer (Dex-NW) has been developed that can release the drug on the ocular surface for a longer duration of time than drops, during which it slowly dissolves. The Dex-NW was fabricated using carboxymethyl cellulose polymer and contains arrays of 500 nm square drug reservoirs filled with Dex. The in vivo efficacy of the Dex-NW was evaluated using an experimental mouse dry eye model. These studies demonstrated that once a day Dex-NW treatment on alternate days during a five-day treatment period was able to restore a healthy ocular surface and corneal barrier function with comparable efficacy to twice a day topically applied dexamethasone eye drop treatment. The Dex-NW was also very effective in down regulating expression of inflammatory cytokines (TNF-α, and IFN-γ), chemokines (CXCL-10 and CCL-5), and MMP-3, that are stimulated by dry eye. Despite less frequent dosing, the Dex-NW has comparable therapeutic efficacy to topically applied Dex eye drops in experimental mouse dry eye model, and these results provide a strong rationale for translation to human clinical trials for dry eye.

Topics: Animals; Anti-Inflammatory Agents; Carboxymethylcellulose Sodium; Cornea; Cytokines; Delayed-Action Preparations; Dexamethasone; Drug Delivery Systems; Dry Eye Syndromes; Female; Mice, Inbred C57BL; Nanostructures

To evaluate effects of a novel multi-ingredient artificial tear formulation containing carboxymethylcellulose (CMC) and hyaluronic acid (HA) in a murine dry eye model.. Dry eye was induced in mice (C57BL/6) using an intelligently controlled environmental system (ICES). CMC+HA (Optive Fusion™), CMC-only (Refresh Tears(®)), and HA-only (Hycosan(®)) artificial tears and control phosphate-buffered saline (PBS) were administered 4 times daily and compared with no treatment (n = 64 eyes per group). During regimen 1 (prevention regimen), mice were administered artificial tears or PBS for 14 days (starting day 0) while they were exposed to ICES, and assessed on days 0 and 14. During regimen 2 (treatment regimen), mice exposed to ICES for 14 days with no intervention were administered artificial tears or PBS for 14 days (starting day 14) while continuing exposure to ICES, and assessed on days 0, 14, and 28. Corneal fluorescein staining and conjunctival goblet cell density were measured.. Artificial tear-treated mice had significantly better outcomes than control groups on corneal staining and goblet cell density (P < 0.01). Mice administered CMC+HA also showed significantly lower corneal fluorescein staining and higher goblet cell density, compared with CMC (P < 0.01) and HA (P < 0.05) in both regimens 1 and 2.. The artificial tear formulation containing CMC and HA was effective in preventing and treating environmentally induced dry eye. Improvements observed for corneal fluorescein staining and conjunctival goblet cell retention suggest that this combination may be a viable treatment option for dry eye disease.

Topics: Animals; Carboxymethylcellulose Sodium; Conjunctiva; Cornea; Disease Models, Animal; Dry Eye Syndromes; Female; Fluorescein; Fluorescent Dyes; Goblet Cells; Hyaluronic Acid; Lubricant Eye Drops; Mice; Mice, Inbred C57BL; Treatment Outcome

The purpose of this work was to gather preliminary data on tear film stability, and the adhesive properties of the corneal surface in dry eye patients and control group subjects, using a new, minimally invasive optical coherence tomography (OCT) imaging method.. We screened 85 human subjects for dry eye and classified them in two groups, as dry eye or normal patients. Sodium carboxymethylcellulose (NaCMC) adhesiveness over the central cornea was measured using Fourier domain anterior segment OCT. The corneal adhesiveness for NaCMC was compared between the two groups, correlated with classical tests, and analyzed for diagnostic validity and repeatability.. The corneal adhesiveness for NaCMC median and mode values was fair (between 1 and 3 minutes) for dry eye subjects (n = 36) and borderline (between 3 and 5 minutes) for control group subjects (n = 49), and was significantly different between the two groups (P < 0.001). Significant correlations were observed between the corneal adhesiveness measures and dry eye patients' symptoms (P < 0.001), Schirmer I test (P < 0.001), ocular surface staining (P < 0.001), and, particularly, fluorescein break-up time (P < 0.001). The area under the receiver operating characteristic curve was 0.94 (P < 0.001), suggesting reliable sensitivity and specificity of OCT imaging. A statistically significant intraclass correlation (ICC) value of 0.99 was found for measurements of corneal adhesiveness on two subsequent days at the same time (P < 0.001).. This minimally invasive, novel technique of OCT imaging of the corneal surface following NaCMC drop instillation provides a measure of corneal adhesiveness. This technique may improve the clinician's ability in the understanding and diagnosis of the dry eye syndrome.

Topics: Adhesiveness; Carboxymethylcellulose Sodium; Cornea; Dry Eye Syndromes; Female; Humans; Male; Middle Aged; Reproducibility of Results; ROC Curve; Surface Properties; Tomography, Optical Coherence

To compare the efficacy of three types of ocular lubricants in protecting corneal epithelial cells in dry eye animal models.. Ocular lubricants containing 0.1% or 0.3% sodium hyaluronate (SH), carboxymethylcellulose (CMC), or hydroxypropyl methylcellulose (HPMC) were tested. First, ocular lubricant containing 0.002% fluorescein was dropped onto the rabbit corneas. The fluorescein intensity as an index of retention was measured. Second, a rabbit dry eye model was made by holding the eye open with a speculum, and 50 μL of each ocular lubricant was dropped onto the cornea. After 3 hours, the corneas were stained with 1% methylene blue (MB), and the absorbance of MB was measured. Third, a rat dry eye model was treated with the ocular lubricants for 4 weeks, and the corneal fluorescein staining was scored. Eyes treated with physiological saline were used as controls. Finally, immunohistochemistry was used to analyze occludin, an epithelial barrier protein, in cultured human corneal epithelial cells pretreated with ocular lubricants and desiccated for 20 or 60 minutes.. Our results showed that 0.3% SH had a significantly longer retention time than the other lubricants (all P < 0.01). The absorbance of MB was significantly lower in the 0.3% SH group. The corneas of rats exposed to 0.3% SH had significantly lower fluorescein staining scores. A significantly higher number of occludin-positive cells were found after exposure to 0.3% SH than other lubricants.. Ocular lubricant containing 0.3% SH would be preferable to treat patients with dry eye syndrome.

Topics: Animals; Carboxymethylcellulose Sodium; Cornea; Disease Models, Animal; Dry Eye Syndromes; Hyaluronic Acid; Hypromellose Derivatives; Male; Methylcellulose; Ophthalmic Solutions; Rabbits; Rats; Treatment Outcome; Viscosupplements

To describe a series of 4 patients with inadequately controlled primary open angle glaucoma and ocular surface disease (OSD) in whom a combination approach was used to manage the OSD resulting in improved intraocular pressure (IOP) control.. A retrospective review of the clinical notes of 4 patients referred to a tertiary surgical glaucoma service was performed. At the initial visit, measures to control the OSD were employed in all patients; twice-daily lid hygiene measures, a 3-month course of 50 mg daily oral doxycycline, topical carmellose sodium (celluvisc) 0.5% 4 to 6 times daily, and preservative-free equivalents of topical antiglaucoma medications as deemed appropriate, depending on the perceived severity of the OSD.. Patients were reviewed for a maximum of 24 months after intervention. In all patients treatment resulted in a marked symptomatic and clinical improvement in the ocular surface with a reduction in hyperemia, meibomian gland dysfunction and superficial keratopathy. A reduction in the IOP also occurred in all patients, obviating the need for glaucoma drainage surgery during the study period.. Patients with severe OSD often have glaucoma that is refractive to medical therapy. Furthermore, the surgical success of glaucoma filtering surgery is compromised in patients with scarring and inflammation of the conjunctiva. The term we postulate is "OSD exacerbated glaucoma." This is the first study to suggest that the use of a combination approach comprising medical treatment to manage the OSD in patients with primary open angle glaucoma may lead to an improvement in the IOP control and the management of glaucoma.

Topics: Aged; Aged, 80 and over; Anti-Bacterial Agents; Antihypertensive Agents; Carboxymethylcellulose Sodium; Conjunctivitis; Doxycycline; Drug Carriers; Dry Eye Syndromes; Eyelid Diseases; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Keratitis; Male; Retrospective Studies

To assess Pseudomonas aeruginosa growth in Refresh Plus(®), a unit-dose preservative-free ophthalmic solution indicated for the treatment of dry eye and after laser-assisted in situ keratomileusis (LASIK) surgery, which contains carboxymethylcellulose 0.5% as its active ingredient.. Multiple test tubes of Refresh Plus were inoculated with 3 clinical ocular isolates of P. aeruginosa to achieve a target concentration of ∼100 colony-forming units (CFU)/mL. The tubes were incubated at 25°C and samples were aseptically removed at 6, 12, and 24 h. The samples were cultured to enumerate the population at each time point.. After 6 h incubation, the number of CFU/mL was 3,200 for isolate 1, 2,000 for isolate 2, and 6,480 CFU/mL for isolate 3. For all 3 organisms tested, the number of CFU/mL after 12 and 24 h incubation was >10(6) CFU/mL.. Under the conditions of this experiment, Refresh Plus appears to support P. aeruginosa growth, suggesting that if the solution in a unit-dose vial of Refresh Plus were contaminated with P. aeruginosa during use, the organism would survive and replicate in the solution over time. Noncompliance with the manufacturer's recommendations (i.e., reuse of an open vial) may result in contamination of the solution with P. aeruginosa, which may cause severe keratitis.

Topics: Carboxymethylcellulose Sodium; Drug Contamination; Drug Delivery Systems; Dry Eye Syndromes; Humans; Keratitis; Keratomileusis, Laser In Situ; Ophthalmic Solutions; Preservatives, Pharmaceutical; Pseudomonas aeruginosa

To compare the dynamic changes in lower tear meniscus area (TMA) and height after instillation of artificial tears in patients with dry eye and healthy controls.. Twenty-two eyes of 11 patients with dry eye and twenty eyes of 10 age- and sex-matched healthy subjects were included. The inferior tear meniscus height and area measurements were taken before and after instillation of 35 μL carboxymethyl cellulose (CMC) 0.5% and 1.0% (Allergan, Irvine, CA) on 2 consecutive days. The measurements were obtained before and 1, 5, 10, 15, and 30 minutes after instillation using anterior segment optical coherence tomography, RTVue-100 (RTVue, Optovue, Inc).. The baseline lower TMA and height in the dry eye group were significantly lower than in the control group. A significant increase in TMA and height was found at 1 minute post instillation of 0.5% CMC in both groups, with findings returning to baseline levels at 5 and 10 minutes post instillation in the control group and dry eye group, respectively. The increase in TMA and height persisted for a longer time period in both groups with 1% CMC, versus 0.5% CMC. At 15 and 30 minutes, both tear meniscus parameters were still significantly higher in the control group and dry eye group, respectively.. Artificial tears provide a significant yet temporary improvement in the tear meniscus. The anterior segment optical coherence tomography is valuable to measure dynamic changes in the tear meniscus.

Topics: Adult; Carboxymethylcellulose Sodium; Dry Eye Syndromes; Female; Fluorescein; Fourier Analysis; Humans; Male; Ophthalmic Solutions; Prospective Studies; Tears; Tomography, Optical Coherence

Topics: Carboxymethylcellulose Sodium; Diagnostic Techniques, Ophthalmological; Dry Eye Syndromes; False Positive Reactions; Humans; Ophthalmic Solutions; Predictive Value of Tests; Reproducibility of Results; Sensitivity and Specificity; Tears; Visual Acuity

To evaluate the normalization of the tear film (tear film normalization test [TNT]) as a diagnostic test for dry eye syndrome.. The uncorrected distance vision of 20 patients with dry eyes (40 eyes) and 20 normals (40 eyes) before and after instillation of carboxymethyl cellulose 0.5% (CMC; Refresh Plus; Allergan, Irvine, CA) was recorded. We used study early treatment diabetic retinopathy (ETDRS) vision charts to test vision in each eye. Tear film breakup time (TBUT), presence or absence of superficial punctate erosions (SPE), tear film meniscus height, meibomian gland function, and ocular surface disease index (OSDI) questionnaire scores were evaluated.. CMC improved visual acuity in the dry eye group (P < 0.0001). Response operator's curve (ROC) analysis showed that vision improvement of 2 lines or more after tear normalization was associated with an 82.5% (95% CI: 66.6%-92.1%) sensitivity and 100% (95% CI: 89.1%-100%) specificity for dry eye. There was a significant correlation between vision improvement and OSDI score in the dry eye group (P = 0.003).. The TNT is a highly sensitive and specific test for dry eyes and is available in every eye care professional's office. The more symptomatic the dry eye, the greater the improvement.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Carboxymethylcellulose Sodium; Child; Diagnostic Techniques, Ophthalmological; Dry Eye Syndromes; False Positive Reactions; Female; Humans; Male; Middle Aged; Ophthalmic Solutions; Predictive Value of Tests; Reproducibility of Results; Sensitivity and Specificity; Tears; Visual Acuity

The aim of this study was to establish a method for analysis of tear film stability and thereby to investigate the effects of lubricants on corneal surface regularity and corneal epithelial damage in anesthetized rabbits with the eye held open. Saline-instilled and noninstilled eyes manifested a time-dependent increase in the corneal surface regularity index (SRI). In contrast, 0.1% hyaluronic acid (HA) prevented the increase in the SRI for up to 20 min after instillation. Methylene blue uptake into the damaged cornea was significantly greater in eyes that received saline than in those treated with HA. Whereas eyes instilled with 0.5% methylcellulose (MC) or 0.35% sodium carboxymethylcellulose (CMC) manifested an increase in the SRI similar to that apparent in those that received saline, 1.0% chondroitin sulfate (CS) prevented the increase in the SRI for up to 10 min after instillation. In conclusion, we have established a method for analysis of tear film stability in rabbits. Our results suggest that tear film stability is closely related to corneal surface damage and that topical instillation of 0.1% HA or 1.0% chondroitin sulfate warrants further investigation as a potential treatment for patients with dry eye.

Topics: Animals; Carboxymethylcellulose Sodium; Chondroitin Sulfates; Corneal Topography; Dry Eye Syndromes; Epithelium, Corneal; Hyaluronic Acid; Male; Methylcellulose; Ophthalmic Solutions; Rabbits

To compare the effect of artificial tears (0.5% carboxymethylcellulose [CMC] in lactate buffer vs. 0.3% hydroxypropyl methylcellulose and 0.1% dextran in bicarbonate buffer [HPMC]) on the preservation of ocular surface health in postoperative laser in situ keratomileusis (LASIK) patients.. Nonrandomized, comparative, retrospective analysis of a clinical database. Patients (n = 519; 985 eyes) had undergone LASIK in a single refractive surgery center performed by a single surgeon using the same LASIK technique (Nidek EC5000 laser and ACS keratome). Patients (n = 254) were given CMC (Refresh Plus/Cellufresh) or HPMC (Bion Tears) four times per day and were evaluated at presurgery, week 2, and months 1, 3, and 6. Included patients were those with complete clinical data through the month I follow-up visit.. There were no significant between-group differences in any baseline variable. Following LASIK, fewer CMC patients (n = 111) reported dry eye symptoms than HPMC patients (n = 143) at the week 2 (13.5% vs. 30.8%; P = .001) and month 1 (19.8% vs. 38.5%; P = .001) follow-up visits. CMC patients also had significantly lower mean ocular surface staining scores than HPMC patients at week 2 (0.09 vs. 0.30; P = .015) and month 1 (0.05 vs. 0.28; P = .008). There were no between-group differences in either measure at months 3 or 6 (P < or = .728).. CMC was more effective than HPMC in controlling dry eye symptoms and preserving ocular surface health in the immediate postoperative period in myopic post-LASIK patients, possibly due to the greater muco-adhesive properties of CMC. These results warrant further investigation as to the most effective postoperative LASIK lubricant.

Topics: Adult; Carboxymethylcellulose Sodium; Contrast Media; Dry Eye Syndromes; Eye; Female; Fluorescein; Health Status; Humans; Hypromellose Derivatives; Incidence; Keratomileusis, Laser In Situ; Male; Methylcellulose; Middle Aged; Ophthalmic Solutions; Retrospective Studies; Staining and Labeling; Surface Properties; Treatment Outcome

Nonpreserved artificial tears (NPAT) are a recommended treatment for dry eye. The manufacturers' instructions state to discard the container after initial opening and use. Some clinicians advocate the use and storage of NPAT in a zip-lock bag in a refrigerator for up to 12 h. The purpose of this study was to evaluate whether refrigeration of opened NPAT over a 12-h period had any effect on the pH or osmolality.. Forty individual carboxymethylcellulose NPAT samples were used in this study. The initial osmolality and pH of each sample were measured with a vapor pressure osmometer and electronic pH meter. The samples were refrigerated (4 degrees C) in closed zip-lock plastic bags for 12 h. After storage, the pH and osmolality of the samples were measured. The data were statistically analyzed for significant differences using a paired t-test.. The mean initial pH and osmolality before refrigeration were 6.46 pH units and 304.10 mmol/kg, respectively. After refrigeration, the mean pH was 6.44 units, and mean osmolality was 305.87 mmol/kg. Paired t-tests revealed a nonsignificant difference (p > 0.05) for both pH and osmolality.. Refrigeration of opened carboxymethylcellulose NPAT stored in closed zip-lock plastic bags does not have a significant effect on the osmolality or pH of the solution. Storage of NPAT containing carboxymethylcellulose is an acceptable practice with regards to stability of pH and osmolality.

Topics: Carboxymethylcellulose Sodium; Cryopreservation; Dry Eye Syndromes; Eye; Humans; Hydrogen-Ion Concentration; In Vitro Techniques; Ophthalmic Solutions; Osmolar Concentration; Refrigeration