Evaluating Injection With the Use of Brimonidine Tartrate Ophthalmic 0.025% on Patients Using Netarsudil 0.02%/Latanoprost 0.005% to Treat Glaucoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Brimonidine Tartrate Ophthalmic 0.025%.
- Who it may be relevant to
- Registry conditions: Glaucoma. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Impact of Brimonidine Tartrate Ophthalmic 0.025% on Patients Using Netarsudil 0.02%/Latanoprost 0.005% to Treat Glaucoma
Overview
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.
Interventions
- Drug Brimonidine Tartrate Ophthalmic 0.025%
Lumify is an approved eye drop to minimize ocular hyperemia.
Primary outcome measures
- Effron Grading scale of ocular redness [Time frame: 2 weeks]
Eligibility criteria
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
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Vision Source — Kansas City
Identifiers
NCT: NCT07209410 · VSE002