Evaluating Injection With the Use of Brimonidine Tartrate Ophthalmic 0.025% on Patients Using Netarsudil 0.02%/Latanoprost 0.005% to Treat Glaucoma
ID: NCT07209410
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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.
Lumify is an approved eye drop to minimize ocular hyperemia.
Treatment Arms Description
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.
- 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.
- 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.
Primary Outcome Measures
- Effron Grading scale of ocular redness — Time Frame: 2 weeks
Measuring Ocular Hyperemia and injection. This is measured on Scale 0-4 0- Normal 1. Trace 2. Mild 3. Moderate 4. Severe
This trial is recruiting at 1 study facilities worldwide. Click below to see if there is a clinic or hospital in your area:
Show All 1 Facilities & Contact Sites
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View Official Medical/Scientific Title
Impact of Brimonidine Tartrate Ophthalmic 0.025% on Patients Using Netarsudil 0.02%/Latanoprost 0.005% to Treat Glaucoma