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Prostaglandin Analog

Timolol + Latanoprost for Glaucoma

Phase 4
Recruiting
Led By Sayoko Moroi, MD, PhD
Research Sponsored by Ohio State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
At least one eye must be phakic
Open-angle with mild-to-moderate stage glaucoma based on history of untreated IOP ≥ 21 mmHg
Must not have
History of glaucoma incisional surgery in study eye(s)
History of oral steroid use within 30 days of screening Visit 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measurement 1 week after treatment
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved
No Placebo-Only Group

Summary

This trial-and-error approach to glaucoma management is inefficient and has not addressed this barrier as there are no predictive factors for drug response.

Who is the study for?
This trial is for people with open-angle glaucoma or ocular hypertension, who have not had certain eye surgeries or treatments. Participants should have an untreated eye pressure of at least 21 mmHg and be able to remove contact lenses for tests. They must also be willing to attend multiple on-site visits and cooperate with study procedures.
What is being tested?
The trial is testing the effects of two eye drop medications, Timolol (a beta-blocker) and Latanoprost (a prostaglandin analogue), on intraocular pressure in patients with glaucoma or high eye pressure. It aims to identify factors that predict how well a patient will respond to these drugs.
What are the potential side effects?
Timolol can cause side effects like burning sensation in eyes, fatigue, shortness of breath, slow heart rate; while Latanoprost may lead to changes in eyelash growth, darkening of the iris color, mild stinging or itching in the eyes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have at least one eye with its natural lens.
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I have glaucoma with a history of high eye pressure above 21 mmHg.
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I have high eye pressure treated for open-angle and recorded twice or at screening.
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My eye pressure is 21mmHg or higher and I haven't been treated for it.
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I can undergo eye fluid tests without difficulty.
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I will not wear contact lenses while using the study medication.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had surgery for glaucoma in my eye(s) involved in the study.
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I have taken oral steroids in the last 30 days.
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I have been on a stable medication for over 30 days that could affect my eye pressure.
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I have had a sudden increase in eye pressure before.
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My eye(s) have Fuchs dystrophy signs like guttae and swelling.
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I have had cycloablation surgery in my eye(s) involved in the study.
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I have a specific eye condition related to the angle of my iris.
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I am not using cannabis, certain eye drops, or steroids.
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I am not pregnant or breastfeeding.
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My eyes do not have ongoing or frequently returning inflammation.
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My study eye has never had SLT or ALT laser treatments for glaucoma.
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I have had a minor glaucoma surgery in my eye(s).
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My study eye(s) have never had surgery to correct vision.
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My eyes have never had a herpes infection.
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I refuse to remove my contact lenses for the study.
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My eyes do not have serious retinal diseases like wet AMD or diabetic retinopathy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measurement 1 week after treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and measurement 1 week after treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Variation in eye pressures between individuals
Secondary study objectives
Variation in aqueous flow between individuals
Variation in episcleral venous pressure

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Timolol 0.5%Experimental Treatment1 Intervention
To compare the variation in response to timolol between individuals
Group II: Latanoprost 0.005%Experimental Treatment1 Intervention
To compare the variation in response to latanoprost between individuals
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Latanoprost 0.005% Ophthalmic Solution
2019
Completed Phase 3
~220
Timolol 0.5% ophthalmic solution
2010
Completed Phase 3
~330

Find a Location

Who is running the clinical trial?

Ohio State UniversityLead Sponsor
866 Previous Clinical Trials
655,061 Total Patients Enrolled
1 Trials studying Glaucoma
32 Patients Enrolled for Glaucoma
University of NebraskaOTHER
555 Previous Clinical Trials
1,145,285 Total Patients Enrolled
7 Trials studying Glaucoma
431 Patients Enrolled for Glaucoma
Mayo ClinicOTHER
3,344 Previous Clinical Trials
3,062,303 Total Patients Enrolled
2 Trials studying Glaucoma
200 Patients Enrolled for Glaucoma

Media Library

Latanoprost 0.005% Ophthalmic Solution (Prostaglandin Analog) Clinical Trial Eligibility Overview. Trial Name: NCT04412096 — Phase 4
Glaucoma Research Study Groups: Timolol 0.5%, Latanoprost 0.005%
Glaucoma Clinical Trial 2023: Latanoprost 0.005% Ophthalmic Solution Highlights & Side Effects. Trial Name: NCT04412096 — Phase 4
Latanoprost 0.005% Ophthalmic Solution (Prostaglandin Analog) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04412096 — Phase 4
~11 spots leftby May 2025
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