Latanoprost Eluting Contact Lens for Treating Glaucoma and Ocular Hypertension

NCT04500574 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2025-10-15

No results posted yet for this study

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

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04500574 on ClinicalTrials.gov