Fluorometholone as Ancillary Therapy for TT Surgery

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:

• Fluorometholone 0.1% one drop twice daily for four weeks
• Placebo one drop twice daily for four weeks
• Fluorometholone 0.1% one drop four times daily for four weeks
• Placebo one drop four times daily for four weeks
• Fluorometholone 0.1% one drop four times daily for eight weeks
• Placebo one drop four times daily for eight weeks

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:

• Treatment-emergent ocular symptoms/signs
• Discontinuation of drug / treatment because of side effects

Safety Parameters:

• Intraocular pressure elevation ≥30 mm Hg
• Cataract
• Adverse events
• Treatment emergent abnormal ophthalmic findings
• Treatment emergent external examination findings
• Visual acuity

Efficacy Parameters:

• Trichiasis recurrence
• Entropion recurrence
• Trachoma activity grade (to the extent activity can be graded in eyes with severe trachomatous scarring)

Inclusion criteria

• Age 18 years or more
• Diagnosis with trachomatous trichiasis
• Plan for lid rotation surgery (Bilamellar Tarsal Rotation) on at least one upper eyelid
• LOCS 3 cataract grading is level 3 or less for the nuclear cataract scale, and level 2 or less for the cortical cataract and posterior subcapsular cataract scales.
• Intraocular pressure between 8-20 mm Hg in the study eye.

Exclusion criteria

• Contraindications to the use of the test articles
• Known allergy or sensitivity to any medication used in this study, including the study medication or its components (e.g., fluorometholone)
• Currently taking more than two ocular anti-hypertensive medications in the study eye (prior IOP-lowering surgery is acceptable; combinations of two agents such as Cosopt and Combigan are considered two medications)
• Glaucoma sufficiently advanced that an intraocular pressure spike potentially would put the patient at substantial risk of vision loss, per study ophthalmologist's judgment.
• Non-phakic (i.e., pseudophakic or aphakic) study eye (contralateral non-phakic eye is permitted).
• Other than trachoma, any active ocular infections (bacterial, viral, or fungal), or any active ocular inflammation (e.g., scleritis, iritis).
• History or diagnosis of ocular herpes or presence of a corneal lesion of suspected herpetic origin; or a diagnosis or suspected diagnosis of ophthalmic mycobacterial infection in either eye.
• Corneal or scleral thinning in either eye.
• A severe / serious ocular pathology or medical condition which may preclude study completion.
• Any condition for which it is anticipated ocular or systemic corticosteroid therapy would be required.
• Unwilling to discontinue use of contact lenses for the duration of the study (should the unusual circumstance of a trachomatous trichiasis patient who uses contact lenses be encountered)
• Any significant illness or condition that could, in the investigator's or sub-investigator's opinion, be expected to interfere with the study parameters or study conduct; or put the subject at significant risk
• For women of childbearing age, currently pregnant and/or breastfeeding, as obtained by self-report (because of concerns about the (programmatic) use of azithromycin in this setting).
• Cataract in the study eye, defined as LOCS-3 cataract grading is level 3.1 or more for the nuclear cataract scale, or level 2.1 or more for the cortical cataract or posterior subcapsular cataract scales.