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Fluorometholone as Ancillary Therapy for TT Surgery

Primary Purpose

Trichiasis, Trachoma, Bilamellar Tarsal Rotation

Status

Completed

Phase

Not Applicable

Locations

Ethiopia

Study Type

Interventional

Intervention

Fluorometholone 0.1% ophthalmic solution

Artificial tears (Placebo)

About this trial

This is an interventional treatment trial for Trichiasis focused on measuring trachoma, trichiasis, trachomatous trichiasis, bilamellar tarsal rotation, fluorometholone, placebo controlled

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Grarbet Tehadiso Mahber (Grarbet Hospital)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

Fluorometholone 0.1% 1 gtt bid x4weeks

Artificial Tears 1 gtt bid x4 weeks

Fluorometholone 0.1% 1 gtt qid x 4 weeks

Artificial Tears 1 gtt qid x4 weeks

Fluorometholone 0.1% 1 gtt qid x 8 weeks

Artificial Tears 1 gtt qid x8 weeks

Arm Description

Fluorometholone 0.1% 1 drop two times daily for four weeks

Fluorometholone 0.1% 1 drop four times daily for four weeks

Fluorometholone 0.1% 1 drop four times daily for eight weeks

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Recurrence of trichiasis in the study eye

Lashes touching the globe or cornea

Full Information

NCT ID

NCT01949454

First Posted

September 19, 2013

Last Updated

April 20, 2016

Sponsor

University of Pennsylvania

Collaborators

Lions Club International Foundation, Berhan Public Health and Eye Care Consultancy PLC, Grarbet Tehadiso Mahber

1. Study Identification

Unique Protocol Identification Number

NCT01949454

Brief Title

Fluorometholone as Ancillary Therapy for TT Surgery

Official Title

Fluorometholone 0.1% as Perioperative Adjunct Therapy for Lid-rotation Surgery in Trachomatous Entropion and Trichiasis, Dose-varying Study

Study Type

Interventional

2. Study Status

Record Verification Date

April 2016

Overall Recruitment Status

Completed

Study Start Date

November 2013 (undefined)

Primary Completion Date

April 2016 (Actual)

Study Completion Date

April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Pennsylvania

Collaborators

Lions Club International Foundation, Berhan Public Health and Eye Care Consultancy PLC, Grarbet Tehadiso Mahber

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Trichiasis, Trachoma, Bilamellar Tarsal Rotation

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

154 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Fluorometholone 0.1% 1 gtt bid x4weeks

Arm Type

Experimental

Arm Description

Fluorometholone 0.1% 1 drop two times daily for four weeks

Arm Title

Artificial Tears 1 gtt bid x4 weeks

Arm Type

Placebo Comparator

Arm Title

Fluorometholone 0.1% 1 gtt qid x 4 weeks

Arm Type

Experimental

Arm Description

Fluorometholone 0.1% 1 drop four times daily for four weeks

Arm Title

Artificial Tears 1 gtt qid x4 weeks

Arm Type

Placebo Comparator

Arm Title

Fluorometholone 0.1% 1 gtt qid x 8 weeks

Arm Type

Experimental

Arm Description

Fluorometholone 0.1% 1 drop four times daily for eight weeks

Arm Title

Artificial Tears 1 gtt qid x8 weeks

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Fluorometholone 0.1% ophthalmic solution

Intervention Type

Other

Intervention Name(s)

Artificial tears (Placebo)

Intervention Description

Artificial tears (Placebo)

Primary Outcome Measure Information:

Title

Safety assessments

Description

Time Frame

Within one year of randomization

Secondary Outcome Measure Information:

Title

Recurrence of trichiasis in the study eye

Description

Lashes touching the globe or cornea

Time Frame

Within one year of randomization

Other Pre-specified Outcome Measures:

Title

Treatment-emergent ocular symptoms/signs

Description

Within the period of randomized treatment (either 4 or 8 weeks from randomization)

Time Frame

Within 4-8 weeks

Title

Discontinuation of drug / treatment because of side effects

Description

During the period of treatment (either 4 or 8 weeks after randomization)

Time Frame

Within 4-8 weeks of randomization

Title

Other adverse events

Time Frame

Within 1 year

Title

Visual acuity

Description

Changes from baseline. Changes could either be favorable or unfavorable.

Time Frame

Within 1 year

Title

Entropion recurrence

Description

Among cases with entropion at baseline, the incidence of entropion recurrence.

Time Frame

Within 1 year

Title

Trachoma activity grade

Description

WHO trachoma activity grade (to the extent activity can be graded in eyes with severe trachomatous scarring)

Time Frame

Within 1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

John H Kempen, MD MPH PhD

Organizational Affiliation

University of Pennsylvania

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Wondu Alemayehu, MD, MPH

Organizational Affiliation

Berhan Public Health & Eye Care Consultancy PLC

Official's Role

Principal Investigator

Facility Information:

Facility Name

Grarbet Tehadiso Mahber (Grarbet Hospital)

City

Butajira

State/Province

Snnpr

Country

Ethiopia

12. IPD Sharing Statement

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Fluorometholone as Ancillary Therapy for TT Surgery

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