Latanoprost Eluting Contact Lens for Treating Glaucoma and Ocular Hypertension
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Glaucoma
- Ocular Hypertension
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: This is a single-center study to assess the safety and feasibility of delivering latanoprost using the latanoprost contact lens (L-CL) delivery system as a treatment for glaucoma or ocular hypertension. The study has two phases. Phase A is an open-label study with 5 participants; these individuals will wear the L-CL in one eye for one week during which time they will be closely followed with examinations for evaluation of safety. If the L-CL is found to be safe after review of the clinical data by a data and safety monitoring board, phase B will be initiated to assess the safety and effectiveness of delivering latanoprost through the L-CL. This is a double-masked double-dummy study. The L-CL arm will have the drug-eluting latanoprost contact lens (L-CL) and a sham drop, and the latanoprost arm will have a C-CL (no drug) with a nightly 0.005% latanoprost drop.Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 85 years
- Gender
- Both males and females
Description
In Phase A of this study, five subjects will wear the latanoprost-eluting contact lens (L-CL) for one week. Phase A is designed to assess for safety and tolerability. In Phase B of this research study, we will compare the L-CL to placebo. Patients will be randomized to one of 2 groups. Subjects in G...
In Phase A of this study, five subjects will wear the latanoprost-eluting contact lens (L-CL) for one week. Phase A is designed to assess for safety and tolerability. In Phase B of this research study, we will compare the L-CL to placebo. Patients will be randomized to one of 2 groups. Subjects in Group 1 will receive the contact lens with latanoprost in it (latanoprost contact lens, or "L-CL") and placebo eye drops. Subjects in Group 2 will receive a standard, commercial contact lens (or "C-CL) that contains no latanoprost but will be given latanoprost eye drops. The placebo contact lens (C-CL) is highly similar to the latanoprost-eluting contact lens but contains no latanoprost. The placebo eye drops look just like latanoprost eye drops but contain no latanoprost.
Tracking Information
- NCT #
- NCT04500574
- Collaborators
- Harvard University
- Investigators
- Principal Investigator: David S Friedman, MD, PhD, MPH Massachusetts Eye and Ear
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