Fluorometholone as Ancillary Therapy for TT Surgery

Summary

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.

Conditions

• Trichiasis
• Trachoma
• Bilamellar Tarsal Rotation

Interventions

DRUG

Fluorometholone 0.1% ophthalmic solution

OTHER

Artificial tears (Placebo)

Artificial tears (Placebo)

Sponsors & Collaborators

• Lions Club International Foundation

  collaborator OTHER

• Berhan Public Health and Eye Care Consultancy PLC

  collaborator OTHER

• Grarbet Tehadiso Mahber

  collaborator OTHER

• University of Pennsylvania

  lead OTHER

Principal Investigators

• John H Kempen, MD MPH PhD · University of Pennsylvania

• Wondu Alemayehu, MD, MPH · Berhan Public Health & Eye Care Consultancy PLC

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-11-30

Primary Completion

2016-04-30

Completion

2016-04-30

Countries

• Ethiopia

Study Locations