An interventional study of Fluorometholone 0.1% ophthalmic solution and Artificial tears (Placebo) in Trichiasis, Trachoma and Bilamellar Tarsal Rotation, sponsored by University of Pennsylvania. Completed at 1 site in Ethiopia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-04-21.
Sponsored by University of Pennsylvania · Not applicable, Interventional, and Treatment
The investigators aim to evaluate a new potentially cost-effective approach to improving trichiasis surgery outcomes, perioperative topical anti-inflammatory therapy. The investigators hypothesize that adjunctive topical fluorometholone therapy following trichiasis surgery will reduce the risk of recurrent trichiasis. The rationale for this hypothesis is that interruption of inflammation postoperatively would reduce postoperative scarring, leading to better outcomes. As an initial step toward evaluating this modality, the investigators believe it to be necessary to evaluate topical corticosteroid therapy in a safety-oriented study, for which the investigators also hypothesize that fluorometholone will have a perioperative safety profile acceptable for large-scale programmatic use. Topical corticosteroid therapy is associated with potential risks of cataract induction and intraocular pressure (IOP) elevation in susceptible individuals. Fluorometholone has lower intraocular penetration than alternative corticosteroids, with correspondingly less IOP-raising effect while still having favorable effects on conjunctival inflammation, and is a low-cost generic drug. Its poor delivery of corticosteroid into the eye itself provides an advantage in this setting, as the major side effects of therapy are the result of intraocular effects, and therapy only is needed to the conjunctiva. However, prior to use in a large-scale trial it is sensible to make sure adverse outcomes are not observed in a substantial number of TT patients in a smaller scale trial. Secondary goals of such a trial are to evaluate alternative topical corticosteroid dosing schedules to identify an optimal dosing schedule and to identify any preliminary signals of potential efficacy.
Protocol Title: Fluorometholone 0.1% as Perioperative Adjunct Therapy for Lid-rotation Surgery in Trachomatous Entropion and Trichiasis, Dose-varying Study
Study Design: Randomized, double-masked, dose-ranging study of three dose levels of fluorometholone 0.1% or placebo in one eye of subjects with trachomatous trichiasis (TT) undergoing lid rotation surgery
Primary Study Objective: Evaluate the safety and tolerability of three (3) doses of fluorometholone 0.1% in subjects with trachomatous trichiasis (TT) undergoing lid rotation surgery (Bilamellar Tarsal Rotation)
Secondary Study Objective: Conduct a preliminary assessment of the efficacy of three (3) doses of fluorometholone 0.1% in subjects with trachomatous trichiasis (TT) undergoing lid rotation surgery (Bilamellar Tarsal Rotation)
Number of Subjects: Up to 156 eyes of up to 156 subjects
Study Population: Subjects with trachomatous trichiasis (TT) undergoing lid rotation surgery (Bilamellar Tarsal Rotation)
Test Articles:
Visit Schedule: Following trichiasis surgery on Day 0, subjects will return for study visits approximately on Days 14, 28, 56, 90, and 365
Tolerability Parameters:
Safety Parameters:
Efficacy Parameters:
39 studies on the registry are indexed under Trachoma; 3 are open to participants now.
This study's enrollment of 154 is below the median of 1,300 across 31 interventional studies indexed under Trachoma.
Browse Trachoma studies →University of Pennsylvania is the lead sponsor of 1,668 studies on the registry; 235 are open to participants now.
Of its 158 completed or terminated interventional studies of FDA-regulated products, 109 (69%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Fluorometholone 0.1% 1 drop two times daily for four weeks
Drug: Fluorometholone 0.1% ophthalmic solution
Other: Artificial tears (Placebo)
Fluorometholone 0.1% 1 drop four times daily for four weeks
Drug: Fluorometholone 0.1% ophthalmic solution
Other: Artificial tears (Placebo)
Fluorometholone 0.1% 1 drop four times daily for eight weeks
Drug: Fluorometholone 0.1% ophthalmic solution
Other: Artificial tears (Placebo)
Artificial tears (Placebo)
Safety assessments
Incident cataract is defined as either: 1) a two-step worsening on the nuclear, cortical, and/or posterior subcapsular LOCS-3 scale; or 2) undergoing cataract surgery prior to that point in follow-up. Intraocular pressure elevation Other dose-limiting toxicity: 1) SAEs (see below) judged as likely related to the treatment by the investigators; 2) vision-threatening non-trachoma infections, e.g., corneal ulcer; 3) anaphylaxis or other events requiring immediate resuscitation; or 4) when the clinician-investigators determine that other AEs observed in a subject would make future applications of the treatment contraindicated on the basis of side effects.
Time frame: Within one year of randomization
Recurrence of trichiasis in the study eye
Lashes touching the globe or cornea
Time frame: Within one year of randomization
Treatment-emergent ocular symptoms/signs
Within the period of randomized treatment (either 4 or 8 weeks from randomization)
Time frame: Within 4-8 weeks
Discontinuation of drug / treatment because of side effects
During the period of treatment (either 4 or 8 weeks after randomization)
Time frame: Within 4-8 weeks of randomization
Other adverse events
Time frame: Within 1 year
Visual acuity
Changes from baseline. Changes could either be favorable or unfavorable.
Time frame: Within 1 year
Entropion recurrence
Among cases with entropion at baseline, the incidence of entropion recurrence.
Time frame: Within 1 year
Trachoma activity grade
WHO trachoma activity grade (to the extent activity can be graded in eyes with severe trachomatous scarring)
Time frame: Within 1 year
The record gives a start of Nov 2013, a primary completion of Apr 2016 and a completion of Apr 2016. It does not say whether these dates are actual or estimated.
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Studies of the drug tested here: Fluorometholone