NCT04500574

Latanoprost Eluting Contact Lens for Treating Glaucoma and Ocular Hypertension

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Massachusetts Eye and Ear Infirmary · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 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.

Conditions

• Glaucoma
• Ocular Hypertension

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-04-03
• Primary completion: 2025-10-10
• Completion: 2025-10-10
• First posted: 2020-08-05
• Last updated: 2025-10-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study