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Prostaglandin Analog

Latanoprost for Glaucoma and Ocular Hypertension

Phase 1
Recruiting
Led By David S Friedman, MD, PhD, MPH
Research Sponsored by Massachusetts Eye and Ear Infirmary
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 - 14 weeks
Awards & highlights

Study Summary

This trial is testing a novel contact lens drug delivery system with latanoprost to lower eye pressure. It will assess safety, tolerability, comfort & feasibility of the new method compared to eye drops.

Eligible Conditions
  • Ocular Hypertension
  • Glaucoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 - 14 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 - 14 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Efficacy assessed by changes in intraocular pressure - Phase B
Incidence of Treatment-Emergent Adverse Events as assessed by ocular infection, corneal epithelial defects, or cystoid macular edema - Phase A
Eye Infection
Secondary outcome measures
Preliminary efficacy - Phase A: % change in IOP from baseline
Tolerability and comfort: questionnaire

Side effects data

From 2016 Phase 4 trial • 379 Patients • NCT02017327
1%
breast neoplasm
1%
intervetebral disk protrusion
1%
prostate cancer
100%
80%
60%
40%
20%
0%
Study treatment Arm
Monoprost
Lumigan 0.01%
Lumigan 0.03% Unit Dose

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Latanoprost contact lensExperimental Treatment1 Intervention
The L-CL arm will have the drug-eluting latanoprost contact lens (L-CL) and a sham drop.
Group II: Topical LatanoprostPlacebo Group1 Intervention
The placebo arm will have a commercial contact lens with no drug with a nightly 0.005% latanoprost drop.

Find a Location

Who is running the clinical trial?

Massachusetts Eye and Ear InfirmaryLead Sponsor
107 Previous Clinical Trials
12,955 Total Patients Enrolled
Harvard UniversityOTHER
232 Previous Clinical Trials
475,064 Total Patients Enrolled
David S Friedman, MD, PhD, MPHPrincipal InvestigatorMassachusetts Eye and Ear

Media Library

Latanoprost (Prostaglandin Analog) Clinical Trial Eligibility Overview. Trial Name: NCT04500574 — Phase 1
Ocular Hypertension Research Study Groups: Topical Latanoprost, Latanoprost contact lens
Ocular Hypertension Clinical Trial 2023: Latanoprost Highlights & Side Effects. Trial Name: NCT04500574 — Phase 1
Latanoprost (Prostaglandin Analog) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04500574 — Phase 1
~14 spots leftby Jun 2025