Fluorometholone as Ancillary Therapy for TT Surgery

NCT01949454 | Completed DMC

• 1 other identifier: SF1707/UND
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

trachoma; trichiasis; trachomatous trichiasis; bilamellar tarsal rotation; fluorometholone; placebo controlled

Outcome Measures

Primary Outcomes (1)

• 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.

  Within one year of randomization

Secondary Outcomes (1)

• Recurrence of trichiasis in the study eye

  Within one year of randomization

Other Outcomes (6)

• Treatment-emergent ocular symptoms/signs

  Within 4-8 weeks

• Discontinuation of drug / treatment because of side effects

  Within 4-8 weeks of randomization

• Other adverse events

  Within 1 year

Study Arms (6)

Fluorometholone 0.1% 1 gtt bid x4weeks

EXPERIMENTAL

Fluorometholone 0.1% 1 drop two times daily for four weeks

Drug: Fluorometholone 0.1% ophthalmic solution

Artificial Tears 1 gtt bid x4 weeks

PLACEBO COMPARATOR

Other: Artificial tears (Placebo)

Fluorometholone 0.1% 1 gtt qid x 4 weeks

EXPERIMENTAL

Fluorometholone 0.1% 1 drop four times daily for four weeks

Drug: Fluorometholone 0.1% ophthalmic solution

Artificial Tears 1 gtt qid x4 weeks

PLACEBO COMPARATOR

Other: Artificial tears (Placebo)

Fluorometholone 0.1% 1 gtt qid x 8 weeks

EXPERIMENTAL

Fluorometholone 0.1% 1 drop four times daily for eight weeks

Drug: Fluorometholone 0.1% ophthalmic solution

Artificial Tears 1 gtt qid x8 weeks

PLACEBO COMPARATOR

Other: Artificial tears (Placebo)

Interventions

Fluorometholone 0.1% ophthalmic solution DRUG

Fluorometholone 0.1% 1 gtt bid x4weeks; Fluorometholone 0.1% 1 gtt qid x 4 weeks; Fluorometholone 0.1% 1 gtt qid x 8 weeks

Artificial tears (Placebo) OTHER

Artificial tears (Placebo)

Artificial Tears 1 gtt bid x4 weeks; Artificial Tears 1 gtt qid x4 weeks; Artificial Tears 1 gtt qid x8 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pennsylvania: lead
• Lions Club International Foundation: collaborator
• Berhan Public Health and Eye Care Consultancy PLC: collaborator
• Grarbet Tehadiso Mahber: collaborator

Study Sites (1)

Grarbet Tehadiso Mahber (Grarbet Hospital)

Butajīra, Snnpr, Ethiopia

Location

MeSH Terms

Conditions

Trichiasis; Trachoma

Interventions

Fluorometholone; Ophthalmic Solutions; Lubricant Eye Drops

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases; Conjunctivitis, Bacterial; Eye Infections, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Chlamydia Infections; Chlamydiaceae Infections; Gram-Negative Bacterial Infections; Eye Infections; Conjunctivitis; Conjunctival Diseases; Corneal Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals; Lubricants

Study Officials

• John H Kempen, MD MPH PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Wondu Alemayehu, MD, MPH

  Berhan Public Health & Eye Care Consultancy PLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 19, 2013
• First Posted: September 24, 2013
• Study Start: November 1, 2013
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: April 21, 2016

Record last verified: 2016-04

Locations

ET (1)