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

Официальное название

Impact of Brimonidine Tartrate Ophthalmic 0.025% on Patients Using Netarsudil 0.02%/Latanoprost 0.005% to Treat Glaucoma

Обзор

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.

Вмешательства

• Препарат Brimonidine Tartrate Ophthalmic 0.025%
  Lumify is an approved eye drop to minimize ocular hyperemia.

Первичные конечные точки

• Effron Grading scale of ocular redness [Срок оценки: 2 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Vision Source — Kansas City

Идентификаторы

NCT: NCT07209410 · VSE002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗