Fluorometholone 0.1% as Perioperative Adjunct Therapy for Lidrotation Surgery in Trachomatous Entropion and Trichiasis, Phase 2, Dose-varying Study Principal Investigator: John H. Kempen, MD, PhD, Department of Ophthalmology, University of Pennsylvania School of Medicine, 3535 Market St, Suite 700 Philadelphia, PA Ethiopia Principal Investigator: Wondu Alemayehu, MD, MPH, P.O. Box 6307, Berhan Blindness Prevention and Public Health, Addis Ababa, Ethiopia

Proposal Elements  Introduction  Aims  Protocol  GANTT chart/timeline  Resources/collaborators/contracts  Project leadership plan  Research team biographies  Literature review  Letters of support  Publication plan  Budget

Project Summary Primary study objective: – to evaluate the safety and tolerability of these three (3) dosing regimens of fluorometholone 0.1% in subjects with trachomatous trichiasis undergoing lid rotation surgery. The secondary study objective: – to evaluate, in a preliminary manner, the efficacy of three (3) dosing regimens of fluorometholone 0.1% in subjects with trachomatous trichiasis undergoing lid rotation surgery. Randomized, double-masked, dose-ranging study of three dose levels of fluorometholone 0.1% in one eye of subjects, with trachomatous trichiasis (TT) undergoing lid rotation surgery 12 months Potential of improving TT surgery success rates, first of this kind of studies in TT surgery.

Relevance Highly relevant to trachoma elimination goal Close link to SF2 investments in trachoma (surgery) Potentially of removing one of the barriers for TT surgery uptake Innovative approach (so far only antibiotics used)

Approach Concept design respects standards of double masked studies (Phase 2, randomized, double- masked, dose-ranging study) 2 goals properly addressed by the study design Main risk iatrogenous consequences addressed Weak description of control measures for other diseases

Investigators Collaborators and Institutional Involvement: -Dr. John H. Kempen is a faculty member of the Departments of Ophthalmology and Biostatistics & Epidemiology of the Perelman School of Medicine at the University of Pennsylvania (Penn). Penn will serve as the primary grantee for this project. Penn has agreed to forego collecting “indirect” costs for the study. -Dr. Wondu Alemayehu is the principal of Berhan Blindness Prevention and Public Health, a private, limited corporation conducting the implementation and evaluation of public health ophthalmology programs in Ethiopia, with a special emphasis on trachoma. -Dr. Alemayehu will further collaborate with Bahir Dar University, which oversees the SAFE trachoma control program in the region of interest. Berhan will be a subcontractee of Penn in implementing the study, and will organize payment of part of the salary of staff members employed by Bahir Dar University for those roles (specified in the budget section) which are part-time. If advantageous, Penn also will subcontract with Bahir Dar University in order to pay these salaries, otherwise Dr. Alemayehu will accomplish this via Berhan. (see Letter of Support from Bahir Dar University). Subcontracts: Penn will subcontract with Berhan to implement the program. If advantageous, Penn also will subcontract with Bahir Dar University in order to pay these salaries, otherwise Dr. Alemayehu will accomplish this via Berhan.

Environment The scientific environment seems adequate The field settings offer good field implementation capacity The subject population has high levels of TT and has been exposed to control programmes already Bahir Dar is the second most important hospital of Addis Ababa, the staff has experience with trachoma and eye care surgeries

Budget 66,454usd Eth budget – 39,000usd for staff salaries – 17,400usd for equipment – 9,850usd for travel 33,546usd Penn budget – 23,465usd PI – 3,734usd drugs and placebo – 5,457usd travel of PI to Ethiopia

Overall Assessment Strengths Innovative Mission critical Link to SF2 priorities Critical for GET2020 Weaknesses Might require follow up study (feasibility) Publication policy left vague Salaries for PI No Lions involvement possible

Recommendation Approval with conditions Appoint expert to research monitoring committee Clarify publication timing Verify feasibility of reducing salary costs to SF