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Carbonic Anhydrase Inhibitor

Pressure-Lowering Eye Drops for Glaucoma (STOP-RGCD Trial)

Phase 3

Waitlist Available

Led By Vittorio Porciattti, DSc

Research Sponsored by University of Miami

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18 to 85 years, inclusive

Be older than 18 years old

Must not have

Currently using prescribed pressure lowering medicines and unwilling to be withdrawn from them

Unwilling or unable to give consent, unwilling to accept randomization, or unable to return for scheduled protocol visits

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 4 years

Awards & highlights

Approved for 10 Other Conditions

All Individual Drugs Already Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial will study whether a retinal ganglion cell function test can predict which glaucoma suspects will benefit from pressure-lowering eye drops.

Who is the study for?

This trial is for adults aged 18-85 who are at risk for glaucoma but currently have normal vision. They should have certain eye conditions like a specific optic disc appearance or family history of glaucoma, and not be on pressure-lowering meds. Excluded are those with other major eye diseases, systemic conditions like diabetes or MS, pregnant/nursing women, or anyone unable to follow the study protocol.

What is being tested?

The study tests if pressure-lowering eye drops can prevent retinal ganglion cell dysfunction in people at risk for glaucoma. Participants with abnormal retina function will receive one of several eye drop treatments; others won't be treated but monitored over four years using noninvasive tests like PERG and OCT.

What are the potential side effects?

Potential side effects from the eye drops may include mild stinging upon application, redness in the eyes, changes in eyelash growth or coloration, darkening of skin around the eyes, blurred vision temporarily after use, and occasionally more serious effects that could affect heart rate or breathing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 85 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am taking prescribed medication to lower my pressure and cannot stop.

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I am willing and able to follow the study's requirements.

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I have age-related macular degeneration.

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I have multiple sclerosis.

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I have Parkinson's disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in retinal nerve fiber layer thickness

Secondary study objectives

Change in Pattern Electroretinogram Amplitude

Change in Pattern Electroretinogram Phase

Side effects data

From 2021 Phase 3 trial • 485 Patients • NCT03825380

Conjunctival hyperaemia

100%

80%

60%

40%

20%

Study treatment Arm

T4032

Lumigan®

Awards & Highlights

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

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.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Abnormal PERG TreatedExperimental Treatment8 Interventions

Participants recognized as Glaucoma suspects with an abnormal PERG test who have been assigned to receive one or more drops in each eye in order to reduce the intraocular pressure by 20%. Drugs could be: Latanoprost 1 drop Once a day (QD) Bimatoprost 1 drop QD Travoprost 1 drop QD Timolol 1 drop Twice a day (BID) Dorzolamide 1 drop Three times a day (TID) Brinzolamide 1 drop BID Acetazolamide and Methazolamide depends on clinicians evaluation. If Clinicians consider necessary, he/she might combine 2 drugs in order to get the desired intraocular pressure.

Group II: Abnormal PERG UntreatedActive Control1 Intervention

Participants recognized as Glaucoma suspects with an abnormal PERG test who have been assigned to not receive therapy or intervention.

Group III: NormalActive Control1 Intervention

Patients with a normal PERG test that will go through the study under observation.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Latanoprost

FDA approved

Travoprost

FDA approved