24-hour Effect of Rocklatan Compared With Latanoprost in Open Angle Glaucoma and Ocular Hypertension Patients

Официальное название

24-hour Effect Of Rocklatan Compared With Latanoprost In Open Angle Glaucoma And Ocular Hypertension Patients

Обзор

The purpose of this study is to evaluate the effect on 24-hour IOP reduction of netarsudil-latanoprost fixed combination in one eye compared to latanoprost alone in the contralateral eye, dosed daily, 1 drop at night (QD, PM) in adult subjects, at least 18 years of age, with open angle glaucoma (OAG) or ocular hypertension (OHT).

Подробное описание

This will be a double-masked, paired-contralateral, descriptive study to evaluate the effect on 24-hour IOP reduction of netarsudil-latanoprost fixed combination in one eye compared to latanoprost alone in the contralateral eye, dosed daily, 1 drop at night (QD, PM) in adult subjects, at least 18 years of age, with open angle glaucoma (OAG) or ocular hypertension (OHT). Study medication will be administered for 14 consecutive days, although the total time of subject participation in the study (including washout from prior treatment, if necessary) may be up to 10 weeks.

Вмешательства

• Препарат Netarsudil 0.02%/latanoprost 0.005% fixed dose combination ophthalmic solution
  Subjects will receive netarsudil-latanoprost fixed combination ophthalmic solution 0.02%/0.005% in one eye and compare it to latanoprost 0.005% in the contralateral eye
• Препарат Latanoprost 0.005% Ophthalmic Solution
  latanoprost 0.005% solution will be applied in the contralateral eye, once daily, QD (PM) for 14 days

Первичные конечные точки

• Change in mean Intraocular Pressure (IOP) [Срок оценки: Change in mean IOP after 2 weeks of treatment with Latanoprost compared to baseline]
• Change in mean IOP [Срок оценки: Change in mean IOP after 2 weeks of treatment with Rocklatan compared to baseline]
• Change in mean IOP [Срок оценки: Change in mean IOP from baseline after 2 weeks of treatment with latanoprost minus change in mean IOP from baseline after 2 weeks of treatment with Rocklatan]

Вторичные конечные точки (4)

• Change in mean nocturnal IOP [Срок оценки: Mean nocturnal IOP will be calculated based on the time points during the sleeping hours (11 PM - 7 AM) after 2 weeks of treatment with Latanoprost compared to baseline]
• Change in mean nocturnal IOP [Срок оценки: Mean nocturnal IOP will be calculated based on the time points during the sleeping hours (11 PM - 7 AM) after 2 weeks of treatment with Rocklatan compared to baseline]
• Change in mean diurnal IOP [Срок оценки: Mean diurnal IOP will be calculated based on the time points during the sleeping hours (7 AM - 11 PM) after 2 weeks of treatment with Latanoprost compared to baseline]
• Change in mean diurnal IOP [Срок оценки: Mean diurnal IOP will be calculated based on the time points during the sleeping hours (7 AM - 11 PM) after 2 weeks of treatment with Rocklatan compared to baseline]

Критерии участия

Критерии включения

• Diagnosis of OHT or mild-to-moderate OAG in both eyes (OAG in one eye and OHT in the fellow eye is acceptable) based on VF, OCT and dilated fundus examination within one year of the screening visit.
• Both eyes must qualify for the study with an IOP of ≥18 mmHg but ≤34 mmHg on history or at the screening visit
• Be able and willing to provide signed informed consent and follow study instructions
• Ability to cooperate with the examinations required for the study and be able to attend all study visits
• If a contact lens wearer, willing to remove contact lenses at least 24 hours prior to each of the study visits.
• Best-corrected visual acuity (BCVA) using ETDRS chart of +0.4 logMAR units (Snellen equivalent \~ 20/50) or better in each eye

Критерии исключения

Ocular:

• Subjects with narrow angles (3 quadrants with Grade 2 or less according to Shaffer Scale), angle closure or a history of angle closure, or peripheral iridotomy in either eye
• Severe glaucomatous damage
• Difference in IOP between eyes > 4 mmHg (unmedicated) at any baseline time point
• Use of more than two ocular hypotensive medications within 30 days of screening
• Chronic or recurrent inflammatory eye diseases in either eye
• Ocular infection or ocular inflammation in the past 3 months in either eye
• Ocular trauma other than corneal abrasion within the past 6 months in either eye
• Clinically significant retinal disease (e.g., severe diabetic retinopathy, exudative or severe non-exudative macular degeneration, macular edema, retinal vein or artery occlusion) in either eye
• Cornea pathologic changes preventing reliable measurement (e.g., scarring, opacity, edema, keratoconus) in either eye
• Myopia greater than -6.00D, or hyperopia greater than +2.00D in either eye
• Central corneal thickness less than 480 μm or greater than 620 μm in either eye
• Previous intraocular surgery other than routine uncomplicated cataract surgery in either eye
• Previous glaucoma intraocular surgery or glaucoma laser procedures (except SLT performed more than 6 months ago) in either eye
• Unilateral intraocular surgery or glaucoma laser procedures
• Previous corneal refractive surgery in either eye (eg, radial keratotomy, PRK, LASIK, corneal cross-linking, etc.)
• Severe dry eye in either eye
• Use of ocular medications in either eye within 30 days of screening, with the exception of IOP-lowering medications (which must be washed out according to the provided schedule), and lubricating drops for dry eye (which may be used throughout the study)
• Known hypersensitivity to any component of the formulation (eg, benzalkonium chloride, etc.), or to topical anesthetic

Systemic:

• Clinically significant systemic diseases which might interfere with the study
• Participation in any interventional study within 30 days prior to screening visit
• Changes of systemic medication that could have an effect on IOP within 30 days prior to screening, or anticipated during the study including, β-adrenergic antagonists, α-adrenergic agonists and antagonists, angiotensin converting enzyme (ACE) inhibitors, angiotensin II receptor blockers
• Recent change in medications that are known to affect IOP within 30 days prior to the screening visit and during the study including: systemic/inhaled steroids, calcium channel blockers, diuretics, and vasodilators
• Women of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control. An adult woman is considered to be of childbearing potential unless she is one year post-menopausal or three months post-surgical sterilization. All females of childbearing potential must have a negative pregnancy test result at the screening examination and must not intend to become pregnant during the study
• Subjects with a known hypersensitivity or contraindications to any of the ingredients in the study medications

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Mayo Clinic in Rochester — Rochester

Публикации

• Nelson W, Tong YL, Lee JK, Halberg F. Methods for cosinor-rhythmometry. Chronobiologia. 1979 Oct-Dec;6(4):305-23. No abstract available. PMID 548245
• Asrani S, Bacharach J, Holland E, McKee H, Sheng H, Lewis RA, Kopczynski CC, Heah T. Fixed-Dose Combination of Netarsudil and Latanoprost in Ocular Hypertension and Open-Angle Glaucoma: Pooled Efficacy/Safety Analysis of Phase 3 MERCURY-1 and -2. Adv Ther. 2020 Apr;37(4):1620-1631. doi: 10.1007/s12325-020-01277-2. Epub 2020 Mar 12. PMID 32166538
• Brubaker JW, Teymoorian S, Lewis RA, Usner D, McKee HJ, Ramirez N, Kopczynski CC, Heah T. One Year of Netarsudil and Latanoprost Fixed-Dose Combination for Elevated Intraocular Pressure: Phase 3, Randomized MERCURY-1 Study. Ophthalmol Glaucoma. 2020 Sep-Oct;3(5):327-338. doi: 10.1016/j.ogla.2020.05.008. Epub 2020 Jun 4. PMID 32768361
• Peace JH, McKee HJ, Kopczynski CC. A Randomized, Phase 2 Study of 24-h Efficacy and Tolerability of Netarsudil in Ocular Hypertension and Open-Angle Glaucoma. Ophthalmol Ther. 2021 Mar;10(1):89-100. doi: 10.1007/s40123-020-00322-1. Epub 2020 Nov 26. PMID 33244711
• Sit AJ, Nau CB, McLaren JW, Johnson DH, Hodge D. Circadian variation of aqueous dynamics in young healthy adults. Invest Ophthalmol Vis Sci. 2008 Apr;49(4):1473-9. doi: 10.1167/iovs.07-1139. PMID 18385065
• Nau CB, Malihi M, McLaren JW, Hodge DO, Sit AJ. Circadian variation of aqueous humor dynamics in older healthy adults. Invest Ophthalmol Vis Sci. 2013 Nov 15;54(12):7623-9. doi: 10.1167/iovs.12-12690. PMID 24243986
• Sit AJ, Weinreb RN, Crowston JG, Kripke DF, Liu JH. Sustained effect of travoprost on diurnal and nocturnal intraocular pressure. Am J Ophthalmol. 2006 Jun;141(6):1131-3. doi: 10.1016/j.ajo.2006.01.049. PMID 16765686
• Brubaker RF. Flow of aqueous humor in humans [The Friedenwald Lecture]. Invest Ophthalmol Vis Sci. 1991 Dec;32(13):3145-66. PMID 1748546

Идентификаторы

NCT: NCT07325240 · 25-012250

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗