tacrolimus and Conjunctivitis

Viruses cause about 80% of all cases of acute conjunctivitis. Human adenoviruses are believed to account for 65% to 90% of cases of viral conjunctivitis, or 20% to 75% of all causes of infectious keratoconjunctivitis worldwide. Epidemic keratoconjunctivitis (EKC) is a highly contagious subset of adenoviral conjunctivitis that has been associated with large outbreaks at military installations and at medical facilities. It is accompanied by severe conjunctival inflammation, watery discharge, and light sensitivity, and can lead to chronic complications such as corneal and conjunctival scarring with discomfort and poor quality of vision. Due to a lack of consensus on the efficacy of any pharmacotherapy to alter the clinical course of EKC, no standard of care exists, therefore many clinicians offer only supportive care.. To assess the efficacy and safety of topical pharmacological therapies versus placebo, an active control, or no treatment for adults with EKC.. We searched the Cochrane Central Register of Controlled Trials (CENTRAL, which contains the Cochrane Eyes and Vision Trials Register; 2021, Issue 4); 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), with no restrictions on language or year of publication. The date of the last search was 27 April 2021.. We included randomized controlled trials in which antiseptic agents, virustatic agents, or topical immune-modulating therapy was compared with placebo, an active control, or no treatment.. We used standard Cochrane methodology.. We identified 10 studies conducted in Asia, Europe, the Middle East, and North Africa with a total of 892 participants who were treated for 7 days to 6 months and followed for 7 days up to 1.5 years. Study characteristics and risk of bias In most studies participants were predominantly men (range: 44% to 90%), with an age range from 9 to 82 years. Three studies reported information on trial registration, but we found no published study protocol. The majority of trials had small sample sizes, ranging from 18 to 90 participants enrolled per study; the only exception was a trial that enrolled 350 participants. We judged most studies to be at high or unclear risk of bias across risk of bias domains. Findings We included 10 studies of 892 EKC participants and estimated combined intervention effects in analyses stratified by steroid-containing control treatment or artificial tears. Six trials contributed to the comparisons of topical interventions (povidone-iodine [PVP-I], trifluridine, ganciclovir, dexamethasone plus neomycin) with artificial tears (or saline). Very low certainty evidence from two trials comparing trifluridine or ganciclovir with artificial tears showed inconsistent effects on shortening the mean duration of cardinal symptoms or signs of EKC. Low certainty evidence based on two studies (409 participants) indicated that participants treated with PVP-I alone more often experienced resolution of symptoms (risk ratio (RR) 1.15, 95% confidence interval (CI) 1.07 to 1.24) and signs (RR 3.19, 95% CI 2.29 to 4.45) during the first week of treatment compared with those treated with artificial tears. Very low certainty evidence from two studies (77 participants) suggested that PVP-I or ganciclovir prevented the development of subepithelial infiltrates (SEI) when compared with artificial tears within 30 days of treatment (RR 0.24, 95% CI 0.10 to 0.56). Four studies compared topical interventions (tacrolimus, cyclosporin A [CsA], trifluridine, PVP-I + dexamethasone) with topical steroids, and one trial compared fluorometholone (FML) plus polyvinyl alcohol iodine (PVA-I) with FML plus levofloxacin. Evidence from one trial showed that more eyes receiving PVP-I 1.0% plus dexamethasone 0.1% had symptoms resolved by day seven compared with those receiving dexamethasone alone (RR 9.00, 95% CI 1.23 to 66.05; 52 eyes). In two trials, fewer eyes treated with PVP-I or PVA-I plus steroid developed SEI within 15 days of treatment compared with steroid alone or steroi. The evidence for the seven specified outcomes was of low or very low certainty due to imprecision and high risk of bias. The evidence that antiviral agents shorten the duration of symptoms or signs when compared with artificial tears was inconclusive. Low certainty evidence suggests that PVP-I alone resolves signs and symptoms by seven days relative to artificial tears. PVP-I or PVA-I, alone or with steroid, is associated with lower risks of SEI development than artificial tears or steroid (very low certainty evidence). The currently available evidence is insufficient to determine whether any of the evaluated interventions confers an advantage over steroids or artificial tears with respect to virus eradication or its spread to initially uninvolved fellow eyes. Future updates of this review should provide evidence of high-level certainty from trials with larger sample sizes, enrollment of participants with similar durations of signs and symptoms, and validated methods to assess short- and long-term outcomes.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Child; Conjunctivitis; Conjunctivitis, Viral; Cyclosporine; Dexamethasone; Female; Fluorometholone; Ganciclovir; Humans; Keratoconjunctivitis; Levofloxacin; Lubricant Eye Drops; Male; Middle Aged; Povidone-Iodine; Tacrolimus; Trifluridine; Young Adult

To compare the safety and efficacy of tacrolimus 0.03% ointment with dexamethasone 0.05% ointment for subepithelial infiltrates (SEIs) following adenoviral keratoconjunctivitis (AK).. A randomized, double blind trial was done. Eligibility criteria was corrected distance visual acuity of 6/9 Snellen or worse for at least 4 weeks with corneal SEIs following AK. The grading of SEIs was done on a scale of 0 to 3; 0, no infiltrates, 1 mild infiltration, 2 moderate infiltration and 3, severe infiltration. Consecutive patients with SEIs following AK were randomized to receive either topical tacrolimus 0.03% or dexamethasone 0.05% ointment twice daily for 6 months. Treatment was successful if there was reduction of SEIs and improvement in vision.. A total of 45 patients each were assigned to the Tacro and Dexa groups, respectively. Baseline characteristics of patients did not differ significantly (P > 0.001). There was a significant change in symptoms, vision and SEIs in both the groups. However, the magnitude was greater in tacro group. Treatment was successful in 37 (92.5%) patients in Tacro and 34 (85%) patients in dexa group. In dexa group, after a period of 1.24 ± 0.24 months, 7 (15.6%) patients developed a significant rise in intraocular pressure (IOP). Three (7.5%) eyes in tacro and 6 (15%) eyes in dexa group had recurrence of SEIs after cessation of therapy.. Tacrolimus 0.03% is an effective alternative to dexamethasone 0.05% with low recurrence rate, no significant rise in IOP but may cause burning and foreign body sensation in some patients.

Topics: Adenovirus Infections, Human; Administration, Topical; Adult; Conjunctivitis; Dexamethasone; Dose-Response Relationship, Drug; Double-Blind Method; Eye Infections, Viral; Female; Follow-Up Studies; Glucocorticoids; Humans; Immunosuppressive Agents; Male; Slit Lamp Microscopy; Tacrolimus; Time Factors; Visual Acuity; Young Adult

To evaluate the efficacy of tacrolimus (FK 506) therapy in patients with ocular cicatricial pemphigoid (OCP).. In a cohort study, six patients with OCP, in whom the disease was not controlled by conventional immunosuppressive agents administered in high doses for an appropriate period of time, were treated with FK 506. The FK 506 was administered orally at the daily dose of 8 mg. Final clinical response to FK 506 was divided into three categories based on the difference between severity of conjunctival inflammation before and after FK 506 therapy. "Total control" of disease activity was defined as residual inflammatory activity of 0.5 or less in the final examination and an inflammation decrement of at least 0.5 between initial and final examination. "Partial control" was defined as final disease activity 1.0 or 1.5 and at least 0.5 decrement of disease activity between initial and final examination. "Uncontrolled inflammation" was defined as final disease activity above 1.5 or no improvement between initial and final activity.. The average age of the patients was 67.5 years (range 50-75 years). Male to female ratio was 1:1. The average duration of OCP prior to beginning of FK 506 treatment was 6.25 years (range 3-12.5 years). The average duration of treatment with FK 506 was 11 months (range 5-18 months). The average disease activity prior to the administration of FK 506 was 2.6 (range 2.0-3.0). The average disease activity at the time when FK 506 was stopped was 2.0 (range 1.0-2.5). In four patients (67%) FK 506 failed to control activity of OCP, and in two patients (33%) the activity was controlled partially.. Although FK 506 was not used in a prospective randomized trial and although we used the drug only in patients with OCP refractory to conventional immunosuppressive agents, it is likely that FK 506 is incapable of controlling the activity of OCP and inducing a remission.

Topics: Administration, Oral; Aged; Cohort Studies; Conjunctivitis; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Pemphigoid, Benign Mucous Membrane; Tacrolimus; Treatment Outcome

The aim of this study was to formulate a novel TAC preparation into an in situ gel for ocular drug delivery, in order to prolong the residence time on mucosal surfaces and increase patient compliance.. The optimal formulation was characterized by surface morphology, gelling capacity, viscosity, stability and. In this study, the TAC in situ gel can be prepared by a simple solvent stirring method, and the optimized formulation exhibited good stability within 3 months. During storage, the initial viscosity of the formula had little change. The results of viscosity measurement showed that TAC in situ gel was typical of pseudo plastic systems and exhibited a marked increase in viscosity stimulated with STF.. TAC combined with in situ gelling agents demonstrates an efficient topical drug delivery platform.

Topics: Conjunctivitis; Drug Delivery Systems; Eye; Gels; Humans; Tacrolimus; Viscosity

A consecutive case series of patients with dupilumab-associated ocular surface disease (DAOSD) that describes common ocular symptoms and signs, proposes a symptom disease severity grading system, and describes treatment strategies of DAOSD patients was evaluated.. A retrospective chart review of patients with concomitant dupilumab-treated atopic dermatitis and DAOSD with ophthalmic evaluation between January 2014 and May 2019 was conducted.. Twenty-nine patients (mean age 46 years, M/F: 12/17) with 57 ophthalmic exams were identified. The most common ocular symptoms included irritation/pain (n = 28, 97%), redness (n = 24, 83%), pruritus (n = 18, 62%), discharge (n = 18, 62%), and light sensitivity (n = 6, 21%). The most frequent signs included conjunctival injection (n = 18, 62%), superficial punctate keratitis (n = 16, 55%), and papillary reaction (n = 8, 28%). Topical corticosteroids (TCS) (n = 23, 79%), tacrolimus (n = 6, 21%), and artificial tears (n = 7, 24%) were the most commonly used therapies. Of those with follow-up documentation (n = 21), 20 were noted to have partial or complete response with TCS based on symptoms and reduction of signs. Using our proposed symptom-based grading scale, scaled 1 to 5 based on the presence of common symptoms listed above, 66% (n = 19) requiring topical immunomodulating therapy were found in the 'severe' group (≥3 symptoms) and 17% (n = 5) were found in the 'mild' group (≤2 symptoms).. This study provides insight into the commonly presenting ocular signs and symptoms associated with DAOSD and highlights the efficacy of TCS and other immunomodulators in improving symptoms associated with DAOSD. Based on our findings, we propose a symptom-based grading system that can guide nonophthalmic physicians regarding ophthalmology consult.

Topics: Adolescent; Adult; Aged; Anti-Allergic Agents; Antibodies, Monoclonal, Humanized; Child; Conjunctivitis; Dermatitis, Atopic; Eye Pain; Female; Follow-Up Studies; Glucocorticoids; Humans; Keratitis; Male; Middle Aged; Retrospective Studies; Severity of Illness Index; Tacrolimus; Treatment Outcome

The aim of this study is to develop a novel in situ gel of tacrolimus-loaded SLNs (solid lipid nanoparticles) for ocular drug delivery.. The optimal formulation was characterized by surface morphology, particle size, zeta potential, entrapment efficiency, drug loading and in vitro release behavior. In vivo studies were also conducted to evaluate the pharmacokinetic and pharmacodynamic results.. In this study, TAC-SLNs ISG were prepared using homogenization followed by probe sonication method. The average particle size of TAC-SLNs ISG was observed to be 122.3±4.3 nm. Compared with TAC-SLNs, in situ gel did not increase particle size, and there was no significant difference between them. The results of viscosity measurement showed that TAC SLNs-ISG were typical of pseudo plastic systems and showed a marked increase in viscosity as temperature increased and ultimately formed a rigid gel (32°C). In vitro and in vivo studies illustrated the sustained release model of the drug from TAC-SLNs ISG. Animal model showed that TAC-SLNs ISG had good pharmacodynamics when compared with eye drops and SLNs.. Our results demonstrated that TAC SLNs-ISG had the potential for being an ideal ocular drug delivery system.

Topics: Animals; Conjunctivitis; Drug Carriers; Drug Delivery Systems; Gels; Lipids; Mice; Mice, Inbred BALB C; Nanoparticles; Ophthalmic Solutions; Particle Size; Surface Properties; Tacrolimus

Atopic dermatitis (AD) is one of the most common inflammatory skin diseases and has aesthetic, physical, and emotional-social sequelae when left untreated.. To classify the most common adverse reactions associated with dupilumab treatment in patients with AD.. The United States Food and Drug Administration Adverse Event Reporting (FAERS) database was analyzed for common adverse reactions associated with dupilumab, topical pimecrolimus, and topical tacrolimus. Phase III clinical trial data were used to compare the rate of herpes infections between the treatment group and placebo group.. The most common adverse reaction associated with dupilumab was ocular complications. Herpes infections were extremely rare in the patients with AD being treated with dupilumab.. Prescribing information for dupilumab, topical pimecrolimus, and topical tacrolimus is not available. Adverse effects are reported by patients, health care providers, and pharmaceutical companies, they have not been corroborated.. Ocular complications are the most common complication associated with dupilumab. The rate of herpes infection is low in patients being treated with dupilumab, topical pimecrolimus, and topical tacrolimus. There is no significant difference for the rate of herpes infection between, placebo, dupilumab, topical pimecrolimus, and the topical tacrolimus treatment group, suggesting that dupilumab does not affect herpes infection rates.

Topics: Antibodies, Monoclonal, Humanized; Blepharitis; Clinical Trials as Topic; Conjunctivitis; Dermatitis, Atopic; Dry Eye Syndromes; Eye Diseases; Herpesviridae Infections; Humans; Hyperemia; Interleukin-13; Interleukin-4; Retrospective Studies; Tacrolimus; United States; United States Food and Drug Administration; Virus Activation

: To characterize the sequelae of microsporidia keratoconjunctivitis (MKC) and outline its management.. Retrospective analysis of microbiologically proven MKC returned with persistent disease between January 2015 and December 2019 was done. Demographics, clinical features, management, and outcome were analyzed.. Sixteen patients (21 eyes) of 332 treated for MKC returned with the persisting disease. The mean age of 11 males (68.7%), and 5 females was 35.1 ± 12.2 years. Three-quarter of them did not have a known predisposing risk factor and one-quarter of them were referred for chronic conjunctivitis. Past medications included topical antivirals (n = 8) and topical corticosteroid (n = 6). Three predominant presentations were persistent (>3 weeks) superficial punctate keratitis (SPKs, n = 7), sub-epithelial infiltrates (SEIs, n = 13), and uveitis (n = 2). The lesions recurred in eight eyes (SPK and SEI 4 each) after a disease-free interval of 60.4 ± 40.6 days; there were 13 episodes of recurrence. Topical low potent corticosteroids (loteprednol/fluorometholone), and tacrolimus ointment 0.03% were used in 17 (80.9%) and 8 (38%) eyes, respectively, for a mean duration of 44.8 ± 31.6 and 226.8 ± 180.5 days, respectively. At follow-up, 172.3 ± 183.6 days, visual recovery was statistically significant in persistent eyes (BCVA 0.07 ± 0.07 logMAR; P < 0.00001) but, not in recurrent eyes (BCVA 0.16 ± 0.08 logMAR; P = 0.07). Five of 21 eyes were left with residual significant scar.. The sequelae of microsporidial keratoconjunctivitis are not uncommon. Topical 0.03% tacrolimus ointment appeared to be an effective corticosteroid-sparing agent for the treatment of SEIs and prevention of recurrence.

Topics: Adult; Conjunctivitis; Female; Humans; Keratoconjunctivitis; Male; Middle Aged; Recurrence; Retrospective Studies; Tacrolimus; Young Adult

Topics: Adult; Antibodies, Monoclonal, Humanized; Conjunctivitis; Dermatitis, Atopic; Female; Humans; Immunocompromised Host; Immunosuppressive Agents; Interleukin-4 Receptor alpha Subunit; Liver Function Tests; Liver Transplantation; Tacrolimus

Patients with atopic dermatitis commonly experience ophthalmic complications, and a higher incidence of conjunctivitis has been observed during treatment with dupilumab. We present the case of a 49-year-old woman with persistent severe atopic dermatitis who complained of refractory conjunctivitis associated with dupilumab. Ocular examination showed features of atopic conjunctivitis for which an external topical application to the eyelids of pimecrolimus 10 mg/g cream was prescribed. The patient showed substantial clinical remission after only 12 days. This case was remarkable as the medication applied externally to the eyelid skin was effective in treating the conjunctival involvement possibly due to penetration of pimecrolimus through the eyelid layers. Further studies are needed to support the use of this drug for dupilumab-related conjunctivitis.

Topics: Administration, Topical; Antibodies, Monoclonal, Humanized; Conjunctivitis; Dermatitis, Atopic; Dermatologic Agents; Eyelids; Female; Humans; Middle Aged; Tacrolimus; Treatment Outcome

To investigate the efficacy and safety of long-term maintenance treatment with tacrolimus ointment in chronic ocular graft-vs-host disease (GVHD) with ocular surface inflammation.. A retrospective interventional consecutive case series.. Long-term maintenance treatment (≥6 months) with topical 0.02% tacrolimus ointment was applied to patients with chronic ocular GVHD with ocular surface inflammation (at least grade 2 inflammatory score). We evaluated the inflammatory score, steroid score and steroid use period of total duration, and numbers of inflammatory aggravations before and after tacrolimus treatment. The clinical outcomes were assessed by symptom score, ocular surface staining, Schirmer I test, tear break-up time (TBUT), and classification of chronic GVHD conjunctivitis at the initial and final examinations.. Thirteen patients (24 eyes) were treated with tacrolimus ointment for up to 20 months (average 12.2 months). The ocular surface inflammatory score decreased from 2.8 to 0.6 (P = .001) within 2-8 weeks after starting tacrolimus ointment treatment. The numbers of inflammatory aggravation and the need for steroid treatment also decreased after initiating tacrolimus treatment. At the final follow-up, all patients reported improvement in clinical outcomes, compared to initial findings. Except for blurred vision or mild burning sensation, there were no reported side effects.. Considering the chronic course of GVHD, long-term maintenance treatment with tacrolimus ointment could be useful and safe to locally treat ocular surface inflammation in chronic ocular GVHD.

Topics: Adolescent; Adult; Child, Preschool; Chronic Disease; Conjunctivitis; Female; Follow-Up Studies; Graft vs Host Disease; Hematopoietic Stem Cell Transplantation; Humans; Immunosuppressive Agents; Keratitis; Leukemia; Male; Middle Aged; Ointments; Retrospective Studies; Tacrolimus; Treatment Outcome; Visual Acuity; Young Adult

Ocular involvement in cicatricial pemphigoid often occurs from the onset. Certain forms are seen only in this condition.. A 31-year-old woman presented highly inflammatory conjunctivitis for several months associated with bilateral symblepharons and superficial punctuate keratitis around the left eye refractory to treatment. The patient had a history of mouth ulcers and sores on the scalp. Examination showed scalp lesions with crusts. Histological examination of these lesions revealed dermal-epidermal cleavage. Direct immunofluorescence showed sub-membrane deposits. Anti-basal membrane antibodies were positive. Immunotransfer confirmed the presence of circulating antibodies. This condition was controlled following administration of three courses of cyclophosphamide as a bolus. However, the symblepharons persisted in both eyes. Improvement lasted 4 years. The patient again consulted for inflammatory conjunctivitis and superficial punctate keratitis resulting in invalidating loss of visual acuity, associated with hypereosinophilia. Cortisone eye drops alone resulted in no improvement. Treatment was initiated with topical tacrolimus (Protopic) 0.03% comprising once-daily application to the conjunctiva in the evening. This therapy was well tolerated, and 2 daily applications could be given, followed by a dosage of 0.1%. Improvement was rapid and spectacular, with frank amelioration of visual acuity and resolution of the patient's keratitis. Treatment was continued for 4 months and gradually reduced to the 0.03% dosage level, with increasingly wide intervals between applications. There has been no relapse within the 12 months following the end of treatment.. Standard treatment of pharmacological cicatricial pemphigoid involves systemic immunosuppression since topical anti-inflammatories are ineffective. The mortality associated with this disease is due to iatrogenic complications. Tacrolimus exhibits extremely good penetration of the conjunctiva. Following administration at a concentration of 0.06% 3 times daily in 15 patients with inflammatory disease of the conjunctiva or the cornea, improvement was seen in 10 of these patients at 26 weeks. Tacrolimus appears to act through immunomodulatory and anti-inflammatory mechanisms. It induces local inhibition of T lymphocyte activation and reduces production of pro-inflammatory lymphokines. Oral tacrolimus cannot be used to control cicatricial pemphigoid refractory to standard immunomodulators. However, 3 three other cases involving topical treatment of cicatricial pemphigoid showed marked efficacy of treatment given for 2 to 6 months, with complete tolerability. Thus, topical tacrolimus appears to constitute an interesting alternative treatment in cicatricial pemphigoid.

Topics: Administration, Topical; Adult; Conjunctivitis; Cyclophosphamide; Eye Diseases; Female; Humans; Immunosuppressive Agents; Injections, Intravenous; Keratitis; Lymphocyte Activation; Pemphigoid, Bullous; T-Lymphocytes; Tacrolimus; Time Factors; Tissue Adhesions; Treatment Outcome; Visual Acuity

Topics: Blepharitis; Chronic Disease; Conjunctivitis; Conjunctivitis, Allergic; Humans; Immunosuppressive Agents; Keratoconjunctivitis; Tacrolimus; Treatment Outcome

To report 4 cases of patients treated with topical tacrolimus ointment 0.03% for ocular inflammatory conditions refractory to traditional treatment.. Four patients were treated topically with tacrolimus 0.03% ointment twice daily: 2 patients with blepharokeratoconjunctivitis, 1 patient with severe atopic keratoconjunctivitis, and 1 patient with chronic follicular conjunctivitis.. Three patients had a dramatic improvement of their ocular condition as early as 2 weeks after starting tacrolimus ointment. One patient developed a herpes simplex virus dendrite after 1 week of tacrolimus use.. Tacrolimus ointment appears to be an effective alternative for certain ocular inflammatory conditions refractory to traditional treatments. There may be an increased risk of herpes simplex virus keratitis associated with topical use. Our results support previous literature of patients benefiting from topical tacrolimus use.

Topics: Administration, Topical; Adult; Aged; Blepharitis; Chronic Disease; Conjunctivitis; Conjunctivitis, Allergic; Drug Administration Schedule; Female; Humans; Immunosuppressive Agents; Keratitis, Dendritic; Keratoconjunctivitis; Male; Middle Aged; Ointments; Tacrolimus; Treatment Outcome

Experimental immune-mediated blepharoconjunctivitis (EC) in Brown Norway (BN) rats, which is inducible by transfer of antigen-specific T cells, is a model for human allergic conjunctivitis. We investigated the possible inhibition of EC in BN rats by topical application of FK506, which is an immunosuppressive agent that mainly targets T cells.. To induce EC by active immunization, ovalbumin (OVA) adsorbed to alum was injected into the hind footpads of BN rats. Three weeks after the initial immunization, rats were challenged with OVA by eye drops. Twenty-four hours later, lids including conjunctivas, lymph nodes (LNs), and sera were harvested for histology or reverse transcriptase PCR, proliferation assays, and measurement of IgE titer, respectively. For passive immunization, rats were intravenously injected with 10 million of in vitro-stimulated OVA-primed LN cells. Four days after the transfer, rats were challenged with OVA and evaluated as above. The rats were divided into two groups. One group received topical FK506 treatment three times per day from 15 to 21 days after active immunization or from 1 to 4 days after transfer. The other group was treated with vehicle as above.. FK506 treatment suppressed infiltration of both lymphocytes and eosinophils in the conjunctiva either by active or passive immunization (P<0.002). No differences were noted in antigen-specific cellular and humoral immune responses. Concerning cytokine expression in the conjunctiva, a prominent difference was noted only with IL-4, which was more abundantly detected in the vehicle-treated group.. Topical FK506 treatment suppressed EC in BN rats, possibly by inhibition of IL-4 in the conjunctiva.

Topics: Administration, Topical; Animals; Blepharitis; Conjunctivitis; Immunization, Passive; Immunosuppressive Agents; Male; Ophthalmic Solutions; Ovalbumin; Rats; Rats, Inbred BN; Tacrolimus

Topical corticosteroids are the only effective measure in serious inflammatory corneal and conjunctival diseases. Although results obtained with topical cyclosporin A are encuraging it is not effective in all patients. The mode of action of Fk506 is similar to that of cyclosporin A, i.e. it exerts an inhibitory effect on transcription of interleukin 2 in T lymphocytes. The immunosuppressive potential of Fk506, however, is much larger. Furthermore, it penetrates more easily into cornea and conjunctiva. To find out whether the theoretical advantages of topical Fk506 can be translated into clinical practice, a selected group of patients refractory to conventional therapy was treated in this pilot study.. Fk506 0.06 % was administered initially three times daily in 15 patients with atopic blepharokeratoconjunctivitis, Mooren's ulcer, ocular pemphigoid, Thygeson's superficial punctate keratitis, nummular adenoviral keratitis, graft-versus-host reaction of the conjunctiva and steroid response glaucoma after penetrating keratoplasty.. Within a follow-up of 26 +/- 15 weeks improvement was recorded in 5/15 patients and stabilization in 5/15 patients. In two patients progression of the disease was noted (one patient with progression of ocular pemphigoid, another patient with suspected automutilation). Premature withdrawal the drug was judged to be necessary in two patients with ocular surface disorders and in one patient with non-compliance.. Topical Fk506 seems to be a promising new immunosuppressive drug for patients with atopic blepharokeratoconjunctivitis, Thygeson's superficial punctate keratitis and nummular adenoviral keratitis. Exact efficacy in these and other corneal and conjunctival inflammatory diseases has to be determined in randomised clinical studies. Before these studies may start the risk of side-effects must be reduced via an improvement of the drops.

Topics: Adult; Aged; Aged, 80 and over; Conjunctivitis; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Interleukin-2; Keratitis; Male; Middle Aged; Ophthalmic Solutions; Pilot Projects; Tacrolimus; Treatment Outcome