Latanoprost Eluting Contact Lens for Treating Glaucoma and Ocular Hypertension
NCT04500574 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 1
Last updated 2025-10-15
Summary
In this research study, we will assess the safety, tolerability, comfort, and feasibility of lowering intraocular pressure using a novel Contact Lens Drug Delivery System with latanoprost. Latanoprost is a well-studied medication and has been used to treat glaucoma for decades. Currently, latanoprost is FDA-approved to be administered to patients as eye drops, but using eye drops has challenges (having to remember to take the drop, getting the drop in the eye). This clinical trial is being done to determine the safety, tolerability, and effectiveness of using latanoprost to deliver latanoprost in a new way (through a drug-eluting contact lens).
The study includes two phases. Phase A is intended to assess safety and tolerability and Phase B to assess safety and effectiveness.
Conditions
Interventions
- DRUG
-
Latanoprost eluting contact lens
The latanoprost-contact lens will be worn in one eye for one week.
- DRUG
-
Topical Latanoprost
A commercial contact lens with no drug will be worn in one eye for one week.
Sponsors & Collaborators
- collaborator OTHER
-
Massachusetts Eye and Ear Infirmary
lead OTHER
Principal Investigators
-
David S Friedman, MD, PhD, MPH · Massachusetts Eye and Ear
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-04-03
- Primary Completion
- 2025-10-10
- Completion
- 2025-10-10
- FDA Drug
- Yes
Countries
- United States
Study Locations
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