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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measurement 1 week after treatment
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ measurement 1 week after treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measurement 1 week after treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Variation in eye pressures between individuals
Secondary outcome measures
Variation in aqueous flow between individuals
Variation in episcleral venous pressure
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
Timolol 0.5% ophthalmic solution
2010
Completed Phase 3
~330
Latanoprost 0.005% Ophthalmic Solution
2019
Completed Phase 3
~220
Find a Location
Who is running the clinical trial?
Ohio State UniversityLead Sponsor
829 Previous Clinical Trials
505,643 Total Patients Enrolled
1 Trials studying Glaucoma
32 Patients Enrolled for Glaucoma
University of NebraskaOTHER
539 Previous Clinical Trials
1,144,634 Total Patients Enrolled
4 Trials studying Glaucoma
195 Patients Enrolled for Glaucoma
Mayo ClinicOTHER
3,207 Previous Clinical Trials
3,766,760 Total Patients Enrolled
2 Trials studying Glaucoma
200 Patients Enrolled for Glaucoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had surgery for glaucoma in my eye(s) involved in the study.I have taken oral steroids in the last 30 days.I have been on a stable medication for over 30 days that could affect my eye pressure.I have had a sudden increase in eye pressure before.I haven't had eye injections in the last 3 months.I have at least one eye with its natural lens.My eye(s) have Fuchs dystrophy signs like guttae and swelling.I can attend all required study visits in person.I have had cycloablation surgery in my eye(s) involved in the study.I have a specific eye condition related to the angle of my iris.My eyes have not had any injuries in the last 6 months, except for a simple scratched cornea.I am not using cannabis, certain eye drops, or steroids.I have severe vision loss or my vision is at risk in the eye(s) being studied.I am not pregnant or breastfeeding.I have glaucoma with a history of high eye pressure above 21 mmHg.My eyes do not have ongoing or frequently returning inflammation.My study eye has never had SLT or ALT laser treatments for glaucoma.I have had a minor glaucoma surgery in my eye(s).My study eye(s) have never had surgery to correct vision.My eyes have never had a herpes infection.I have high eye pressure treated for open-angle and recorded twice or at screening.I refuse to remove my contact lenses for the study.My eye pressure is 21mmHg or higher and I haven't been treated for it.My eyes have not had an infection in the last 3 months.I will remove my contact lenses for the eye test and keep them out until after the test the next day.My eyes do not have serious retinal diseases like wet AMD or diabetic retinopathy.I can undergo eye fluid tests without difficulty.I will not wear contact lenses while using the study medication.
Research Study Groups:
This trial has the following groups:- Group 1: Timolol 0.5%
- Group 2: Latanoprost 0.005%
Awards:
This trial has 3 awards, including:- 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.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals have registered for this clinical experiment?
"Accurate. Information stored on clinicaltrials.gov indicates that this medical experiment, initially posted on November 23rd 2020, is actively enrolling individuals for participation. A total of 200 subjects must be gathered from 3 different locations."
Answered by AI
What other research has been conducted into the effects of Latanoprost 0.005% Ophthalmic Solution?
"Latanoprost 0.005% Ophthalmic Solution was initially studied in 2007 at Singapore National Eye Centre, and there are now 279 finished studies on record. Currently, 16 active clinical trials of this drug can be found around Omaha, Nebraska."
Answered by AI
What adverse effects could result from the use of Latanoprost 0.005% Ophthalmic Solution?
"Our team at Power rated Latanoprost 0.005% Ophthalmic Solution's safety as a 3 since it has been greenlighted by the FDA and is in Phase 4 trials, indicating prior clinical data supporting its efficacy."
Answered by AI
Are there any available slots for individuals to participate in this clinical experiment?
"As per the data available on clinicaltrials.gov, this trial is currently open for enrollment. The protocol was first made visible to the public on November 23rd 2020 and has been modified most recently as of July 15th 2022."
Answered by AI
What conditions commonly benefit from Latanoprost 0.005% Ophthalmic Solution?
"Latanoprost 0.005% Ophthalmic Solution is generally prescribed to individuals whose symptoms do not respond adequately to beta-blockers, and it can also be utilized as adjunctive or replacement therapy for patients with open angle glaucoma (OAG) and prophylaxis of migraine headaches."
Answered by AI
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