loteprednol-etabonate and Dry-Eye-Syndromes

Dry eye disease (DED), arising from various etiologic factors, leads to tear film instability, ocular surface damage, and neurosensory changes. DED causes symptoms such as ocular dryness, burning, itching, pain, and visual impairment. Given their well-established anti-inflammatory effects, topical steroid preparations have been widely used as a short-term treatment option for DED. Because of potential risks of ocular hypertension, cataracts, and infections associated with the long-term use of topical steroids, published trials comparing the efficacy and safety of topical steroids (versus placebo) have mostly been of short duration (three to eight weeks).. To evaluate the effectiveness and safety of topical corticosteroids compared with no treatment, placebo, other steroidal or non-steroidal therapies, or a combination of therapies for DED.. We searched the Cochrane Central Register of Controlled Trials (CENTRAL, which contains the Cochrane Eyes and Vision Trials Register; 2021, Issue 8); Ovid MEDLINE; Ovid Embase; Latin American and Caribbean Health Sciences database (LILACS); ClinicalTrials.gov; and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP), without restriction on language or year of publication. The date of the last search was 20 August 2021.. We included randomized controlled trials (RCTs) in which topical corticosteroids, alone or in combination with tobramycin, were compared with no treatment, artificial tears (AT), vehicles, AT plus tobramycin, or cyclosporine A (CsA).. We applied standard Cochrane methodology.. We identified 22 RCTs conducted in the USA, Italy, Spain, China, South Korea, and India. These RCTs reported outcome data from a total of 4169 participants with DED.  Study characteristics and risk of bias All trials recruited adults aged 18 years or older, except one trial that enrolled children and adolescents aged between 3 and 14 years. Half of these trials involved predominantly female participants (median 79%, interquartile range [IQR] 76% to 80%). On average, each trial enrolled 86 participants (IQR 40 to 158). The treatment duration of topical steroids ranged between one week and three months; trial duration lasted between one week and six months. Eight trials were sponsored exclusively by industry, and four trials were co-sponsored by industry and institutional or governmental funds. We assessed the risk of bias of both subjective and objective outcomes using RoB 2, finding nearly half of the trials to be at high risk of bias associated with selective outcome reporting. Findings Of the 22 trials, 16 evaluated effects of topical steroids, alone or in combination with tobramycin, as compared with lubricants (AT, vehicle), AT plus tobramycin, or no treatment. Corticosteroids probably have a small to moderate effect on improving patient-reported symptoms by 0.29 standardized mean difference (SMD) (95% confidence interval [CI] 0.16 to 0.42) as compared with lubricants (moderate certainty evidence). Topical steroids also likely have a small to moderate effect on lowering corneal staining scores by 0.4 SMDs (95% CI 0.18 to 0.62) (moderate certainty evidence). However, steroids may increase tear film break-up time (TBUT) slightly (mean difference [MD] 0.70 s, 95% CI 0.06 to 1.34; low certainty evidence) but not tear osmolarity (MD 1.60 mOsm/kg, 95% CI -10.47 to 13.67; very low certainty evidence).  Six trials examined topical steroids, either alone or in combination with CsA, against CsA alone. Low certainty evidence indicates that steroid-based interventions may have a small to moderate effect on improving participants' symptoms (SMD -0.33, 95% CI -0.51 to -0.15), but little to no effect on corneal staining scores (SMD 0.05, 95% CI -0.25 to 0.35) as compared with CsA. The effect of topical steroids compared to CsA alone on TBUT (MD 0.37 s, 95% CI -0.13 to 0.87) or tear osmolarity (MD 5.80 mOsm/kg, 95% CI -0.94 to 12.54; loteprednol etabonate alone) is uncertain because the certainty of the evidence is low or very low. None of the included trials reporte

Topics: Adolescent; Adrenal Cortex Hormones; Adult; Cataract; Child; Child, Preschool; Cyclosporine; Dry Eye Syndromes; Female; Glucocorticoids; Humans; Loteprednol Etabonate; Lubricant Eye Drops; Male; Randomized Controlled Trials as Topic; Tobramycin

Dry eye disease (DED) is a common ocular condition that can impair vision and may adversely impact quality of life. Due to the inflammatory nature of this disorder, topical corticosteroids are an effective treatment option, particularly for moderate-to-severe DED when first-line treatments, such as ocular lubricants, are insufficient. Loteprednol etabonate (LE) is a retrometabolically designed corticosteroid with a low propensity to cause corticosteroid-related adverse effects, such as elevated intraocular pressure (IOP). This review was conducted to provide an assessment of published studies on the use of LE for treatment of inflammation associated with DED. Twelve prospective and 2 retrospective studies evaluating LE ophthalmic suspension 0.5% and 2 prospective studies evaluating LE ophthalmic gel 0.5% were identified. LE given as monotherapy or with artificial tears (AT) improved signs of DED, especially among patients with a more pronounced inflammatory component, and also improved DED symptoms compared to baseline and/or control. Treatment with LE before cyclosporine A (CsA) therapy reduced stinging upon CsA initiation and provided more rapid relief of DED signs and symptoms than CsA plus AT alone. In patients with meibomian gland dysfunction, LE alone, or in addition to eyelid scrubs/warm compresses, reduced clinical signs and symptoms, and tear proinflammatory cytokine levels. Overall, LE was safe and well tolerated, with minimal effects on IOP. While larger and longer-term studies are warranted, these data support the use of LE as a safe and effective treatment option for DED.

Topics: Animals; Anti-Allergic Agents; Cyclosporine; Dry Eye Syndromes; Humans; Inflammation; Loteprednol Etabonate; Lubricant Eye Drops; Quality of Life

Topical corticosteroids are an important pharmacotherapy for the management of various inflammatory conditions affecting the anterior segment of the eye. However, medications in this class are associated with well-known risks including increased intraocular pressure (IOP) and development of cataracts. The topical corticosteroid loteprednol etabonate (LE) was developed with the specific intention of minimizing these side effects.. The focus of this review is to examine published efficacy and safety data for LE, a drug engineered to undergo rapid metabolism to inactive metabolites with the goal of improved safety. Two decades of clinical research focused on LE formulations are reviewed, including the use of LE in combination with tobramycin. The cumulative body of experience affirms the concept that the molecular design of LE confers certain safety benefits without compromising the desired anti-inflammatory efficacy of a topical corticosteroid.. Loteprednol etabonate is a mainstay for topical therapy of a wide variety of commonplace and niche conditions of the ocular surface and the anterior segment, including in the healing post-operative patient. Its versatility and safety allow eye care providers to recommend both acute induction as well as chronic maintenance therapy with appropriate follow-up.

Topics: Clinical Trials as Topic; Conjunctivitis, Allergic; Dry Eye Syndromes; Eye Diseases; Glucocorticoids; Humans; Loteprednol Etabonate; Ointments; Ophthalmic Solutions; Uveitis, Anterior

Ocular inflammatory diseases impose a significant medical and economic burden on society. Corticosteroids are potent anti-inflammatory agents that have been used successfully to treat ocular inflammation. Topical corticosteroids provide maximal drug delivery, and are used to reduce the signs and symptoms of intraocular and ocular surface inflammation. However, side effects associated with topical corticosteroids-including increased intraocular pressure, risk of cataract formation after long-term use, and decreased resistance to infection-are concerns. Loteprednol etabonate (LE) is an ester corticosteroid with a high therapeutic index that contains an ester, rather than a ketone, at carbon-20 of the prednisolone core structure. LE blocks the release and action of inflammatory mediators and is clinically effective in the treatment of steroid-responsive inflammatory conditions including giant papillary conjunctivitis, seasonal (intermittent) allergic conjunctivitis and uveitis. LE relieves ocular surface and lacrimal gland inflammation associated with dry eye and is used in combination with ciclosporin A as a treatment of dry eye. LE is also effective in the treatment of postoperative ocular inflammation. Because of its rapid de-esterification to inactive metabolites, LE appears to have an improved safety profile compared with ketone corticosteroids, and may be more suitable than ketone corticosteroids for the treatment for ocular inflammatory conditions in which long-term therapy is necessary. However, further comparative safety studies are needed.

Topics: Androstadienes; Anti-Inflammatory Agents; Conjunctivitis; Conjunctivitis, Allergic; Dry Eye Syndromes; Endophthalmitis; Humans; Loteprednol Etabonate; Postoperative Complications; Uveitis, Anterior

To evaluate the effect of tapered doses of loteprednol-etabonate in dry eye disease patients.. Dry eye and treatment outcomes were assessed by Schirmer I test, tear BUT, lissamine green conjunctival staining, fluorescein corneal staining, and HLA-DR expression on conjunctival cells. Patients received either loteprednol-etabonate 0.5% twice daily for 14 days tapered to once daily for 14 days, and then twice weekly for 28 days (. A significant decrease of ocular surface inflammation and improvement of symptoms was recorded in the study group compared with controls at days 14 and 56. Change from baseline in HLA-DR expression in CD45+ conjunctival cells was significantly higher in treated patients at day 14. Intraocular pressure and best corrected visual acuity were preserved in all treated eyes.. Tapered doses of loteprednol etabonate 0.5% suspension controlled ocular surface inflammation, improving dry eye symptoms.

Topics: Dry Eye Syndromes; HLA-DR Antigens; Humans; Inflammation; Loteprednol Etabonate; Ophthalmic Solutions; Pilot Projects

The safety of KPI-121 0.25%, an ophthalmic nanoparticle suspension of loteprednol etabonate, was evaluated in subjects with dry eye disease (DED) in one phase 2 and three phase 3 randomized trials of similar design.. Adults with DED received KPI-121 0.25% or vehicle drops 4 times daily (QID) for ≥2 weeks; 1430 subjects received KPI-121 0.25% and 1438 subjects received vehicle drops. Main safety assessments were adverse events (AEs) and intraocular pressure (IOP). As a common side effect associated with the use of ocular corticosteroids is elevated IOP, subjects with a history of or current diagnosis of glaucoma were excluded.. Instillation site pain was the most common AE, reported by 5.2% of subjects in the KPI-121 0.25% group and 4.4% of subjects in the vehicle group; other AEs were reported by ≤0.8% of subjects in the KPI-121 group. IOP elevations, a side effect associated with the use of ophthalmic corticosteroids, were observed with low incidence: 0.6% and 0.2% of subjects in the KPI-121 and vehicle groups, respectively. An IOP elevation was defined as an increase from baseline of >5 mm Hg that resulted in an IOP of ≥21 mm Hg in either eye during use of the study product.. KPI-121 ophthalmic suspension 0.25% seemed to be safe and well tolerated when dosed QID for 2 to 4 weeks in those DED subjects included in the 4 trials.

Topics: Administration, Ophthalmic; Adolescent; Adult; Aged; Aged, 80 and over; Anti-Allergic Agents; Double-Blind Method; Drug-Related Side Effects and Adverse Reactions; Dry Eye Syndromes; Eye Pain; Female; Humans; Intraocular Pressure; Loteprednol Etabonate; Male; Middle Aged; Nanoparticles; Ophthalmic Solutions; Suspensions; Tonometry, Ocular; Visual Acuity; Young Adult

To compare the response of dry eye disease (DED) to treatment with topical steroid in patients with and without graft-vs-host disease (GVHD).. Post hoc analysis of a double-masked, randomized clinical trial.. This single-center study included 42 patients with moderate-to-severe DED associated with (n = 21) or without (n = 21) chronic GVHD. In each group, patients received either loteprednol etabonate 0.5% ophthalmic suspension or artificial tears twice daily for 4 weeks. Clinical data, including Ocular Surface Disease Index (OSDI) questionnaire, corneal fluorescein staining (CFS), conjunctival lissamine green staining, tear break-up time (TBUT), and Schirmer test, were evaluated before and after treatment.. There were no significant differences in signs and symptoms of DED between the groups at baseline. In non-GVHD patients receiving loteprednol treatment, the average OSDI score decreased by 34% from 49.5 ± 5.9 to 32.6 ± 4.8 (mean ± standard error of the mean, P = .001) and the average CFS score decreased by 41% from 5.6 ± 0.6 to 3.3 ± 0.9 (P = .02). On the other hand, loteprednol treatment in GVHD patients resulted in minimal change in OSDI (59.2 ± 6.7 to 61.1 ± 7.1, 3% increase, P = .66) and CFS (5.5 ± 0.5 to 5.3 ± 1.1, 4% decrease, P = .85) scores. Treatment with artificial tears resulted in 22% decrease of OSDI (P = .10) and 32% decrease of CFS (P = .02) scores in non-GVHD patients, and had minimal effect in patients with GVHD.. DED patients with ocular GVHD have a less favorable response to a low-dose topical steroid regimen compared with those without ocular GVHD even with similar baseline disease severity.

Topics: Administration, Ophthalmic; Anti-Allergic Agents; Chronic Disease; Conjunctiva; Double-Blind Method; Dry Eye Syndromes; Female; Fluorescein; Fluorophotometry; Glucocorticoids; Graft vs Host Disease; Humans; Loteprednol Etabonate; Lubricant Eye Drops; Male; Middle Aged; Prospective Studies; Staining and Labeling; Surveys and Questionnaires; Tears; Treatment Outcome

To evaluate whether levels of corneal subbasal nerve fiber length (SNFL) in dry eye disease (DED) could prognosticate the level of improvement in signs and symptoms after treatment.. Phase IV, double-masked, randomized clinical trial.. Sixty patients with meibomian gland dysfunction-associated DED and 27 age-matched controls.. Patients with DED were randomized to receive topical artificial tears, loteprednol etabonate 0.5%, or loteprednol etabonate 0.5%/tobramycin 0.3% twice daily for 4 weeks. At baseline, in vivo confocal microscopy of central cornea was performed in both eyes. Patients with DED were divided into 2 subgroups: those with low baseline SNFL and those with near-normal baseline SNFL for this purpose (the cutoff point: the mean SNFL in controls minus 2 standard deviations). Clinical signs and symptoms at baseline and after 4 weeks of treatment were compared between the subgroups with low and near-normal SNFL for all therapeutic groups.. Symptom questionnaires, corneal fluorescein staining (CFS), conjunctival staining with lissamine green, tear break-up time, Schirmer's test, and SNFL.. In patients with DED, baseline SNFL (17.06±5.78 mm/mm(2)) was significantly lower than in controls (23.68±3.42 mm/mm(2), P = 0.001). In the artificial tear and loteprednol groups, although no significant improvement in any sign or symptom was noted in patients with low baseline SNFL (<16.84 mm/mm(2)), subjects with near-normal baseline SNFL (≥16.84 mm/mm(2)) showed significant improvement in both symptoms and CFS score (all P < 0.05). In the loteprednol/tobramycin group, no significant change was evident for any sign or symptom in either subgroup of low or near-normal baseline SNFL.. Significant improvements in CFS and patient symptomatology after DED treatment were evident only in the subgroup with near-normal corneal SNFL. Consideration of SNFL may assist in explaining the variability of patients' response to DED therapy.

Topics: Androstadienes; Anti-Allergic Agents; Anti-Bacterial Agents; Cornea; Double-Blind Method; Drug Therapy, Combination; Dry Eye Syndromes; Eyelid Diseases; Female; Humans; Loteprednol Etabonate; Lubricant Eye Drops; Male; Meibomian Glands; Microscopy, Confocal; Middle Aged; Ophthalmic Nerve; Ophthalmic Solutions; Prospective Studies; Surveys and Questionnaires; Tobramycin

To evaluate the safety and efficacy of topical loteprednol etabonate (LE) 0.5% compared with cyclosporine A (CsA) 0.05% for the prophylaxis and treatment of dry eye syndrome (DES) after hematopoietic stem cell transplantation (HSCT).. Seventy-five patients were randomized to LE (n = 76 eyes of 38 patients) or CsA (n = 74 eyes of 37 patients) pre-HSCT. Lissamine green and fluorescein staining, tear break-up time, tear osmolarity (Osm), Schirmer score (Sch), intraocular pressure, visual acuity, and Ocular Surface Disease Index were assessed pre-HSCT, 3, 6, 9, and 12 months post-HSCT.. There were no differences in DES incidence (P = 0.22; log-rank test) or progression (P = 0.41; log-rank test) between the 2 treatment arms during the course of the study. Among eyes with no DES at enrollment, the Kaplan-Meier analysis yielded a 90% rate of DES development in cyclosporine-treated eyes and a 79% rate of DES development in LE-treated eyes by 12 months post-HSCT. The Kaplan-Meier analysis of eyes with DES at enrollment demonstrated a 38% rate of disease progression among cyclosporine-treated eyes and a 26% rate of disease progression among loteprednol-treated eyes by 12 months. No patient in either group had an elevation of 10 mm Hg or greater from baseline at any study visit, and no patients had their treatment discontinued for elevation in intraocular pressure.. Pre-HSCT initiation of LE 0.5% appears to be safe and may be as effective as CsA 0.5% for the treatment and prophylaxis of DES following HSCT.

Topics: Administration, Topical; Adult; Aged; Anti-Allergic Agents; Cyclosporine; Dry Eye Syndromes; Female; Hematopoietic Stem Cell Transplantation; Humans; Immunosuppressive Agents; Intraocular Pressure; Loteprednol Etabonate; Male; Middle Aged; Ophthalmic Solutions; Osmolar Concentration; Prospective Studies; Tears; Treatment Outcome; Visual Acuity; Young Adult

The purpose of this work was to evaluate the effect of loteprednol etabonate (LE) before the initiation of topical cyclosporine A (tCsA) therapy in patients with mild-to-moderate dry eye disease. Prospective, multicenter randomized double-masked parallel group clinical study (NCT00407043).. Hundred and eighteen patients with dry eye disease were randomized to receive either LE and tCsA (n=61) or artificial tears (AT) and tCsA (n=57). Hundred and twelve patients completed the study (LE: n=57, AT: n=55) and are included in the data analysis. Patients self-administered either LE or AT for 2 weeks 4 times per day, followed by tCsA twice per day accompanied by either LE twice per day or AT twice per day for an additional 6 weeks of treatment. Primary outcome measures included the Ocular Surface Disease Index (OSDI) questionnaire, the Likert scale using standardized facial expressions, lissamine green staining, fluorescein staining, and the Schirmer test. Additional measures included global self-assessment, and safety outcomes included slitlamp examination, intraocular pressure, and assessment of visual acuity.. Loteprednol etabonate pretreatment significantly reduced tCsA stinging (P<0.05). Both groups showed significantly improved OSDI scores at the 14-, 30-, and 60-day visits. Loteprednol etabonate showed significantly more OSDI improvement than AT. Both pretreatment strategies improved global self-assessment scores, Schirmer test, fluorescein staining, lissamine staining, and adjunctive AT use. Loteprednol etabonate showed superior improvement in Schirmer test, fluorescein staining, and lissamine staining. Intraocular pressure did not increase in either group.. Loteprednol etabonate induction therapy 2 weeks before the initiation of long-term tCsA treatment for chronic dry eye disease provides more rapid relief of dry eye signs and symptoms with greater efficacy than tCsA and AT alone.

Topics: Adult; Aged; Aged, 80 and over; Analysis of Variance; Androstadienes; Anti-Allergic Agents; Cyclosporine; Double-Blind Method; Drug Therapy, Combination; Dry Eye Syndromes; Female; Humans; Immunosuppressive Agents; Loteprednol Etabonate; Male; Middle Aged; Ophthalmic Solutions; Prospective Studies; Visual Acuity

To observe the efficacy and safety of 0.5% Loteprednol Etabonate ophthalmic suspension in the treatment of moderate dry eye.. Totally 34 dry eye patients (68 eyes) in grade 2 or grade 3 (DEWS standard) enrolled in our hospital from March 2009 to September 2010 were randomly divided into two groups: the experimental group (Loteprednol Etabonate Group) and the control group (Cyclosporine A, CsA group). 0.5% Loteprednol Etabonate ophthalmic suspension or 1% CsA eye drops was applied 2 times a day respectively together with 0.2% Liposic eye drops (4 - 6 times/day). Questionnaire was used in these patients before the treatment and repeated every 2 weeks during the treatment till 8 weeks. Slit lamp microscope examination, fluorescent staining, tear break-up time (BUT), Schirmer I test (SIt) and intraocular pressure measurement were carried out at the same time point. The conjunctival impression cytology (IC) was performed before the treatment and 8 weeks after the treatment. The mean of the results were compared by t-tests and χ(2) test.. After 2 weeks of the treatment, the mean score of the questionnaire was significantly lower than that before the treatment in each group (t = 5.36, 3.63, P < 0.01). After 4 weeks of the treatment, the inflammation of the ocular surface was relieved obviously in both group and the mean score of the corneal fluorescein staining (FL) was lower than that before the treatment in each group. The average density of the goblet cells before the treatment was (181.2 ± 16.1)/mm(2) and (179.4 ± 17.5)/mm(2) in each group respectively. After 8 weeks of the treatment, this increased to (348.6 ± 22.5)/mm(2) and (360.4 ± 27.8)/mm(2) significantly (t = 16.9, 16.3, P < 0.05). BUT was significantly prolonged in each group after the treatment (P < 0.01). There was no significant change in ST I or NCT in each group (P > 0.05).. Topical 0.5% Loteprednol Etabonate ophthalmic suspension is safe and effective for the treatment of moderate dry eye.

Topics: Adult; Androstadienes; Cyclosporine; Dry Eye Syndromes; Female; Humans; Loteprednol Etabonate; Male; Middle Aged; Treatment Outcome; Young Adult

Loteprednol etabonate is a soft corticosteroid that is rapidly deactivated after reaching the general circulation, displaying good local activity and a high therapeutic index without inducing systemic side effects. In 2021, Kala Pharmaceuticals launched Eysuvis (loteprednol etabonate ophthalmic suspension) 0.25% in the U.S. for the short-term (up to 2 weeks) treatment of the signs and symptoms of dry eye disease. Approval by the Food and Drug Administration (FDA) was based on results from one phase II trial and three phase III trials showing Eysuvis significantly improved both the signs and symptoms of dry eye disease and was well tolerated. Eysuvis is a novel loteprednol etabonate nanosuspension formulation developed by Kala using its AMPPLIFY mucus-penetrating particle (MPP) drug delivery technology. Use of this MPP formulation results in enhanced penetration of loteprednol etabonate into target tissue on the ocular surface. Eysuvis is the first FDA-approved ocular corticosteroid indicated for dry eye disease.

Topics: Clinical Trials, Phase II as Topic; Clinical Trials, Phase III as Topic; Dry Eye Syndromes; Humans; Loteprednol Etabonate; Ophthalmic Solutions; United States; United States Food and Drug Administration

Topics: Anti-Allergic Agents; Drug Approval; Dry Eye Syndromes; Humans; Loteprednol Etabonate; Ophthalmic Solutions; Randomized Controlled Trials as Topic; United States; United States Food and Drug Administration

The aim of the current study is to compare the effects of two corticosteroids, prednisolone acetate 1% (PA) and loteprednol etabonate 0.5% (LE), for the treatment of benzalkonium chloride (BAC)-induced dry eye syndrome (DES) in rats.. DES was established by topical administration of 0.2% BAC, a commonly used preservative in ophthalmic drugs, for 1 week. Rats were divided into 3 groups just after establishment of DES: PA-treated (Group 1, n=10), LE-treated (Group 2, n=10), and vehicle-treated (Group 3, n=10). Rats were treated by topical administration of PA, LE, or vehicle twice daily for 1 week. The Schirmer test, break-up time score, Fluorescein staining, Rose Bengal staining, and inflammatory index scoring (IIS) tests were performed at all weeks. After the end of the study, eyes of the rats were enucleated and analyzed using light microscopy.. The mean aqueous tear volume was significantly increased in both PA- and LE-treated rats (P<0.05), although decreased in vehicle-treated rats (P>0.05). Histologically, diffuse inflammatory cell infiltration was observed in vehicle-treated rats, while inflammation induced by BAC was almost completely resolved in both PA- and LE-treated groups.. In the current study, we showed that both PA and LE are effective treatments in a rat model of BAC-induced DES, which is commonly observed in clinics. No significant differences were observed between the 2 corticosteroids in the efficacy of BAC-induced type of DES treatment.

Topics: Administration, Topical; Androstadienes; Animals; Benzalkonium Compounds; Disease Models, Animal; Dry Eye Syndromes; Inflammation; Loteprednol Etabonate; Male; Prednisolone; Preservatives, Pharmaceutical; Rats; Rats, Wistar; Tears

This retrospective, clinical comparative analysis describes differences in clinical signs and symptoms and medication tolerability between those patients who receive topical corticosteroids prior to initiation of topical cyclosporine 0.5% emulsion (tCSA) therapy for chronic dry eye disease (CDED) and those who received tCSA and were not first induced with corticosteroid drops. tCSA is the only approved medication for CDED. Stinging is the most common side effect of tCSA and reason for tCSA discontinuation. This analysis describes an effective pharmacologic means to reduce tCSA stinging and subsequent discontinuation.. Thirty-six consecutive patients were initially treated with loteprednol etabonate (LE) 0.5% (Lotemax; Bausch & Lomb) for a period ranging from 2 to 16 months prior to institution of concomitant tCSA (Restasis™; Allergan). Clinical parameters (fluorescein staining, conjunctival redness, tear meniscus) were compared over a period of 6 months to a second cohort of 36 consecutive patients who were initially prescribed continuous tCSA without concomitant LE pretreatment. Patients in the LE pretreatment group discontinued LE after 3-6 months of concomitant therapy while continuing tCSA therapy.. Of the 36 LE pretreatment patients, only 2 developed significant stinging (5.5%) and 1 discontinued the use of tCSA because of stinging (2.8%). Of the patients without LE pretreatment, 8 developed stinging (22%) and 3 discontinued tCSA as a result (8.3%). The intergroup P value was significant for severe stinging (<0.02) and for tCSA discontinuation because of severe stinging (<0.04). Patients in the LE pretreatment group had no statistically significant differences in preenrollment disease severity or demographics (P range from 0.19 to 0.59) compared with the group without pretreatment.. Topical corticosteroid preparation of the ocular surface in CDED with LE induction therapy may reduce discomfort from subsequent long-term maintenance topical medications, particularly tCSA. This analysis describes a readily available induction and maintenance pharmacologic strategy to reduce tCSA stinging and subsequent discontinuation.

Topics: Administration, Topical; Adrenal Cortex Hormones; Adult; Aged; Aged, 80 and over; Androstadienes; Chronic Disease; Cohort Studies; Cyclosporine; Dry Eye Syndromes; Eye Pain; Female; Humans; Immunosuppressive Agents; Loteprednol Etabonate; Male; Middle Aged; Retrospective Studies