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

NCT ID: NCT07209410

Last Updated: 2025-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-01

Study Completion Date

2027-06-01

Brief Summary

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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.

Detailed Description

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Conditions

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Glaucoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Brimonidine Tartrate

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.

Group Type EXPERIMENTAL

Brimonidine Tartrate Ophthalmic 0.025%

Intervention Type DRUG

Lumify is an approved eye drop to minimize ocular hyperemia.

Interventions

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Brimonidine Tartrate Ophthalmic 0.025%

Lumify is an approved eye drop to minimize ocular hyperemia.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 1\. Adult patients 18-65 years old diagnosed with open-angle glaucoma or ocular hypertension.

2\. Currently on netarsudil 0.02%/latanoprost 0.005% monotherapy for a minimum of 2-6 weeks.

3\. 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.

4\. 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.

5\. 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.

Exclusion Criteria

1. Allergy or hypersensitivity to brimonidine or other components of brimonidine tartrate 0.025% or netarsudil 0.02%/latanoprost 0.005%.
2. Use of any other topical ocular medications.
3. Active ocular infection, inflammation unrelated to glaucoma therapy, uveitis, iritis or congenital aphakia.
4. Have pterygium/pinguecula, chemosis, episcleritis, scleritis (or any condition that may affect hyperemia grading) in the opinion of the investigator
5. Have moderate or severe dry eyes.
6. Pregnant, plan to become pregnant or breastfeeding.
7. Concurrent or past use in the last 90 days of vasoconstrictive ocular drops other than brimondine 0.025%
8. Have undergone previous incision IOP lowering surgeries.
9. 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.
10. Have had intraocular or per-ocular surgery within the past 3 months.
11. Advanced glaucoma or c/d ratio greater than 0.8. Are non-responsive to topical treatment with netarsudil 0.02%/latanoprost 0.005%.
12. 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Insight Eyecare Specialties, Inc. dba Vision Source Eyecare,

OTHER

Sponsor Role lead

Responsible Party

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Crystal Remington

Optometrist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Vision Source

Kansas City, Missouri, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Crystal Remington Optometrist, OD

Role: CONTACT

816-531-9100

Facility Contacts

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Megan Hefter Research Coordinator

Role: primary

816-531-9100

Other Identifiers

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VSE002

Identifier Type: -

Identifier Source: org_study_id

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