Latanoprost for Glaucoma and Ocular Hypertension

Recruiting in Palo Alto (17 mi)

Overseen by David S Friedman, MD, PhD, MPH

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Massachusetts Eye and Ear Infirmary

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Research Team

David S Friedman, MD, PhD, MPH

Principal Investigator

Massachusetts Eye and Ear

Eligibility Criteria

Inclusion Criteria

18 - 85 years of age willing and able to give informed consent and in the investigator's judgment able to follow the study protocol

You have certain eye conditions like high eye pressure or specific types of glaucoma. If you have mild to moderate glaucoma, it's defined by a specific test result.

You are using latanoprost eye drops in one of your eyes, and it is effectively controlling the pressure inside your eye.

Exclusion Criteria

Participation in an investigational drug or device study within the 30 days before screening

Any condition (including the inability to read visual acuity charts or language barrier) which precludes a patient's ability to comply with study requirements including completion of the study

You have had a complicated cataract surgery with loss of vitreous.

Treatment Details

Interventions

• Latanoprost (Prostaglandin Analog)

Participant Groups

Group I: Latanoprost contact lens Experimental Treatment 1 Intervention

The L-CL arm will have the drug-eluting latanoprost contact lens (L-CL) and a sham drop.

Group II: Topical Latanoprost Placebo Group 1 Intervention

The placebo arm will have a commercial contact lens with no drug with a nightly 0.005% latanoprost drop.

Who Is Running the Clinical Trial?

Massachusetts Eye and Ear Infirmary

Lead Sponsor

Trials

115

Recruited

15,000+

CarolAnn Williams

Massachusetts Eye and Ear Infirmary

Chief Executive Officer

MBA from Harvard Business School

Aalok Agarwala

Massachusetts Eye and Ear Infirmary

Chief Medical Officer since 2019

MD from University of California, Los Angeles

Harvard University

Collaborator

Trials

237

Recruited

588,000+

Dr. Christopher Anzalone

Harvard University

Chief Executive Officer since 2007

PhD in Biology from UCLA

Dr. Perry

Harvard University

Chief Medical Officer since 2011

MD from Albert Einstein College of Medicine, MPH from Harvard University