NCT07325240 24-hour Effect of Rocklatan Compared With Latanoprost in Open Angle Glaucoma and Ocular Hypertension Patients
| NCT ID | NCT07325240 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Mayo Clinic |
| Condition | Open Angle Glaucoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-11-21 |
| Primary Completion | 2027-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 30 participants in total. It began in 2025-11-21 with a primary completion date of 2027-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
Eligibility Criteria
Inclusion Criteria * 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 Exclusion Criteria 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
Contact & Investigator
Arthur J Sit, MD, MS
PRINCIPAL INVESTIGATOR
Mayo Clinic
Frequently Asked Questions
Who can join the NCT07325240 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Open Angle Glaucoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07325240 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07325240 currently recruiting?
Yes, NCT07325240 is actively recruiting participants. Contact the research team at Halder.Bridgette@mayo.edu for enrollment information.
Where is the NCT07325240 trial being conducted?
This trial is being conducted at Rochester, United States.
Who is sponsoring the NCT07325240 clinical trial?
NCT07325240 is sponsored by Mayo Clinic. The principal investigator is Arthur J Sit, MD, MS at Mayo Clinic. The trial plans to enroll 30 participants.