Fluorometholone as Ancillary Therapy for TT Surgery

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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

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:

        1. Fluorometholone 0.1% one drop twice daily for four weeks

        2. Placebo one drop twice daily for four weeks

        3. Fluorometholone 0.1% one drop four times daily for four weeks

        4. Placebo one drop four times daily for four weeks

        5. Fluorometholone 0.1% one drop four times daily for eight weeks

        6. 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)
    


Study Type

Interventional


Primary Outcome

Safety assessments

Secondary Outcome

 Recurrence of trichiasis in the study eye

Condition

Trichiasis

Intervention

Fluorometholone 0.1% ophthalmic solution

Study Arms / Comparison Groups

 Fluorometholone 0.1% 1 gtt bid x4weeks
Description:  Fluorometholone 0.1% 1 drop two times daily for four weeks

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

154

Start Date

November 2013

Completion Date

April 2016

Primary Completion Date

April 2016

Eligibility Criteria

        Inclusion Criteria:

          1. Age 18 years or more

          2. Diagnosis with trachomatous trichiasis

          3. Plan for lid rotation surgery (Bilamellar Tarsal Rotation) on at least one upper
             eyelid

          4. 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.

          5. Intraocular pressure between 8-20 mm Hg in the study eye.

        Exclusion Criteria:

          1. Contraindications to the use of the test articles

          2. Known allergy or sensitivity to any medication used in this study, including the study
             medication or its components (e.g., fluorometholone)

          3. 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)

          4. Glaucoma sufficiently advanced that an intraocular pressure spike potentially would
             put the patient at substantial risk of vision loss, per study ophthalmologist's
             judgment.

          5. Non-phakic (i.e., pseudophakic or aphakic) study eye (contralateral non-phakic eye is
             permitted).

          6. Other than trachoma, any active ocular infections (bacterial, viral, or fungal), or
             any active ocular inflammation (e.g., scleritis, iritis).

          7. 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.

          8. Corneal or scleral thinning in either eye.

          9. A severe / serious ocular pathology or medical condition which may preclude study
             completion.

         10. Any condition for which it is anticipated ocular or systemic corticosteroid therapy
             would be required.

         11. 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)

         12. 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

         13. 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).

         14. 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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

John H Kempen, MD MPH PhD, , 

Location Countries

Ethiopia

Location Countries

Ethiopia

Administrative Informations


NCT ID

NCT01949454

Organization ID

SF1707/UND


Responsible Party

Principal Investigator

Study Sponsor

University of Pennsylvania

Collaborators

 Lions Club International Foundation

Study Sponsor

John H Kempen, MD MPH PhD, Principal Investigator, University of Pennsylvania


Verification Date

April 2016