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临床试验/NCT01949454
NCT01949454已完成不适用

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

University of Pennsylvania1 个研究点 分布在 1 个国家目标入组 154 人开始时间: 2013年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
154
试验地点
1
主要终点
Safety assessments

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

Fluorometholone 0.1% 1 gtt bid x4weeks

Experimental

Fluorometholone 0.1% 1 drop two times daily for four weeks

干预措施: Fluorometholone 0.1% ophthalmic solution (Drug)

Artificial Tears 1 gtt bid x4 weeks

Placebo Comparator

干预措施: Artificial tears (Placebo) (Other)

Fluorometholone 0.1% 1 gtt qid x 4 weeks

Experimental

Fluorometholone 0.1% 1 drop four times daily for four weeks

干预措施: Fluorometholone 0.1% ophthalmic solution (Drug)

Artificial Tears 1 gtt qid x4 weeks

Placebo Comparator

干预措施: Artificial tears (Placebo) (Other)

Fluorometholone 0.1% 1 gtt qid x 8 weeks

Experimental

Fluorometholone 0.1% 1 drop four times daily for eight weeks

干预措施: Fluorometholone 0.1% ophthalmic solution (Drug)

Artificial Tears 1 gtt qid x8 weeks

Placebo Comparator

干预措施: Artificial tears (Placebo) (Other)

结局指标

主要结局

Safety assessments

时间窗: Within one year of randomization

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.

次要结局

  • Recurrence of trichiasis in the study eye(Within one year of randomization)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

John Kempen

Professor

University of Pennsylvania

研究点 (1)

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