Latanoprost Eluting Contact Lens for Treating Glaucoma and Ocular Hypertension

NCT04500574 | Terminated Phase 1 DMC FDA Drug

• 2 other identifiers: 2020P0019162020A000354
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief 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

Glaucoma; Ocular Hypertension

Keywords

Latanoprost; Glaucoma; Ocular Hypertension; Drug eluting contact lens

Outcome Measures

Primary Outcomes (3)

• Incidence of Treatment-Emergent Adverse Events as assessed by ocular infection, corneal epithelial defects, or cystoid macular edema - Phase A

  Safety assessed by the occurrence of the following adverse events: ocular infection, corneal epithelial defects or signs of corneal toxicity that are not contact lens staining patterns, superficial punctate or vortex, cystoid macular edema

  6 - 14 weeks

• Incidence of Treatment-Emergent Adverse Events as assessed by ocular infection, corneal epithelial defects, or cystoid macular edema - Phase B

  Safety assessed by the occurrence of the following adverse events: ocular infection, corneal epithelial defects or signs of corneal toxicity that are not contact lens staining patterns, superficial punctate or vortex, cystoid macular edema

  6 weeks

• Efficacy assessed by changes in intraocular pressure - Phase B

  Effectiveness: % change in intraocular pressure (IOP) from baseline (following washout, i.e., on no medications) in each arm ; Difference in mean intraocular pressure comparing the L-CL arm to the topical latanoprost arm; % change in IOP in each arm compared to baseline IOP on topical latanoprost

  6 weeks

Secondary Outcomes (2)

• Preliminary efficacy - Phase A: % change in IOP from baseline

  6 - 14 weeks

• Tolerability and comfort: questionnaire

  6- 14 weeks

Study Arms (2)

Latanoprost contact lens

EXPERIMENTAL

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

Drug: Latanoprost eluting contact lens

Topical Latanoprost

PLACEBO COMPARATOR

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

Drug: Topical Latanoprost

Interventions

Latanoprost eluting contact lens DRUG

The latanoprost-contact lens will be worn in one eye for one week.

Latanoprost contact lens

Topical Latanoprost DRUG

A commercial contact lens with no drug will be worn in one eye for one week.

Topical Latanoprost

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age willing and able to give informed consent and in the investigator's judgment able to follow the study protocol
• Ocular hypertension, primary open-angle glaucoma, pigmentary or pseudoexfoliation glaucoma, with mild to moderate glaucoma defined as Mean Deviation on Humphrey Visual Field testing no worse than -10 dB
• Patients on latanoprost in the study eye with an adequate IOP control with latanoprost alone

You may not qualify if:

• Systemic
• Use of oral carbonic anhydrase inhibitors
• Unstable dose of oral medication during the last 30 days that in the opinion of the Investigator may influence the IOP
• Unstable dose of oral steroid at the time of enrollment
• Use of immunosuppressants, immunomodulators, antimetabolites and/or alkylating agents within six months before screening or anticipated use at any time during the study
• Known allergy or hypersensitivity to the study medication or its components
• Female patients who are pregnant, nursing, or planning a pregnancy, or who are of childbearing potential and not using a reliable means of contraception
• Participation in an investigational drug or device study within the 30 days before screening
• Patient has a condition or is in a situation which, in the Investigator's opinion, may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient's participation in the study
• 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
• Study Eye
• History of complex cataract surgery with vitreous loss
• History of cystoid macular edema or uveitis
• Corneal decompensation or edema
• Corneal thickness \<500 or \> 600 μm in the study eye by pachymetry

Sponsors & Collaborators

• Massachusetts Eye and Ear Infirmary: lead
• Harvard University: collaborator

Study Sites (1)

Massachusetts Eye and Ear

Boston, Massachusetts, 02114, United States

Location

Related Publications (4)

• Ciolino JB, Ross AE, Tulsan R, Watts AC, Wang RF, Zurakowski D, Serle JB, Kohane DS. Latanoprost-Eluting Contact Lenses in Glaucomatous Monkeys. Ophthalmology. 2016 Oct;123(10):2085-92. doi: 10.1016/j.ophtha.2016.06.038. Epub 2016 Aug 29.

  PMID: 27586444 BACKGROUND

• Ciolino JB, Stefanescu CF, Ross AE, Salvador-Culla B, Cortez P, Ford EM, Wymbs KA, Sprague SL, Mascoop DR, Rudina SS, Trauger SA, Cade F, Kohane DS. In vivo performance of a drug-eluting contact lens to treat glaucoma for a month. Biomaterials. 2014 Jan;35(1):432-9. doi: 10.1016/j.biomaterials.2013.09.032. Epub 2013 Oct 4.

  PMID: 24094935 BACKGROUND

• Friedman DS, Wolfs RC, O'Colmain BJ, Klein BE, Taylor HR, West S, Leske MC, Mitchell P, Congdon N, Kempen J; Eye Diseases Prevalence Research Group. Prevalence of open-angle glaucoma among adults in the United States. Arch Ophthalmol. 2004 Apr;122(4):532-8. doi: 10.1001/archopht.122.4.532.

  PMID: 15078671 BACKGROUND

• Sleath B, Blalock S, Covert D, Stone JL, Skinner AC, Muir K, Robin AL. The relationship between glaucoma medication adherence, eye drop technique, and visual field defect severity. Ophthalmology. 2011 Dec;118(12):2398-402. doi: 10.1016/j.ophtha.2011.05.013.

  PMID: 21856009 BACKGROUND

MeSH Terms

Conditions

Glaucoma; Ocular Hypertension

Interventions

Latanoprost

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• David S Friedman, MD, PhD, MPH

  Massachusetts Eye and Ear

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, MPH, Director Glaucoma Services

Model Details: 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.

Study Record Dates

• First Submitted: July 28, 2020
• First Posted: August 5, 2020
• Study Start: April 3, 2024
• Primary Completion: October 10, 2025
• Study Completion: October 10, 2025
• Last Updated: October 15, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)