Evaluating Injection With the Use of Brimonidine Tartrate Ophthalmic 0.025% on Patients Using Netarsudil 0.02%/Latanoprost 0.005% to Treat Glaucoma

NCT07209410 | Recruiting Phase 4 FDA Drug

• 1 other identifier: VSE002
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the effect of brimonidine tartrate 0.025% on conjunctival hyperemia in patients treated with netarsudil 0.02%/latanoprost 0.005% mono-therapy for intraocular pressure lowering.

Conditions

Glaucoma

Keywords

Glaucoma; Hyperemia

Outcome Measures

Primary Outcomes (1)

• Effron Grading scale of ocular redness

  Measuring Ocular Hyperemia and injection. This is measured on Scale 0-4 0- Normal 1. Trace 2. Mild 3. Moderate 4. Severe

  2 weeks

Study Arms (1)

Brimonidine Tartrate

EXPERIMENTAL

Patients experiencing hyperemia greater than grade 2 on Efron scale will receive brimonidine tartrate (Lumify). Photo documentation of hyperemia and patient satisfaction questionnaires will be administered.

Drug: Brimonidine Tartrate Ophthalmic 0.025%

Interventions

Brimonidine Tartrate Ophthalmic 0.025% DRUG

Lumify is an approved eye drop to minimize ocular hyperemia.

Brimonidine Tartrate

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Adult patients 18-65 years old diagnosed with open-angle glaucoma or ocular hypertension.
• \. Currently on netarsudil 0.02%/latanoprost 0.005% monotherapy for a minimum of 2-6 weeks.
• \. Able to move from current topical glaucoma treatment to netarsudil 0.02%/latanoprost 0.005% for a minimum of 4 weeks or longer based on FDA recommended washout per drug classification prior to Visit 3.
• \. Experience conjunctival redness as graded on the Efron scale of at least grade 2 after minimum of 4 weeks on netarsudil 0.02%/latanoprost 0.005% mono-therapy or longer based on recommended washout per drug classification 4. Have a best corrected Visual Acuity by Snellen chart of 20/30 or better in study eye.
• \. Are willing and able to self-administer or have an able person available to assist with administration of study drug.
• Willing and able to comply with study procedures and attend follow-up visits.

You may not qualify if:

• Allergy or hypersensitivity to brimonidine or other components of brimonidine tartrate 0.025% or netarsudil 0.02%/latanoprost 0.005%.
• Use of any other topical ocular medications.
• Active ocular infection, inflammation unrelated to glaucoma therapy, uveitis, iritis or congenital aphakia.
• Have pterygium/pinguecula, chemosis, episcleritis, scleritis (or any condition that may affect hyperemia grading) in the opinion of the investigator
• Have moderate or severe dry eyes.
• Pregnant, plan to become pregnant or breastfeeding.
• Concurrent or past use in the last 90 days of vasoconstrictive ocular drops other than brimondine 0.025%
• Have undergone previous incision IOP lowering surgeries.
• Have undergone previous laser surgery for glaucoma (selective laser trabeculoplasty (SLT) or argon laser trabeculoplasty (ALT)), or microinvasive glaucoma surgery (MIGS) with 6 months of screening.
• Have had intraocular or per-ocular surgery within the past 3 months.
• Advanced glaucoma or c/d ratio greater than 0.8. Are non-responsive to topical treatment with netarsudil 0.02%/latanoprost 0.005%.
• In the judgement of the investigator, have previous or currently active clinically significant systemic or ocular disease in either eye that could affect study outcomes.

Sponsors & Collaborators

• Insight Eyecare Specialties, Inc. dba Vision Source Eyecare,: lead

Study Sites (1)

Vision Source

Kansas City, Missouri, 64111, United States

RECRUITING

MeSH Terms

Conditions

Glaucoma; Hyperemia

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Crystal Remington Optometrist, OD

CONTACT

816-531-9100; drremington@vseyecare.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Optometrist

Study Record Dates

• First Submitted: October 1, 2025
• First Posted: October 7, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: November 18, 2025

Record last verified: 2025-11

Locations

US (1)