Rocklatan versus latanoprost for 24-hour eye pressure control in open-angle glaucoma and ocular hypertension
24-hour Effect Of Rocklatan Compared With Latanoprost In Open Angle Glaucoma And Ocular Hypertension Patients
This trial tests whether a combination eye drop (Rocklatan) lowers eye pressure over 24 hours more than latanoprost alone in adults with open-angle glaucoma or ocular hypertension.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT07325240 on ClinicalTrials.gov |
What this trial studies
This double-masked, paired-contralateral Phase 4 study gives the netarsudil-latanoprost fixed combination (Rocklatan) to one eye and latanoprost alone to the other eye, with both drops dosed once nightly. Adult subjects with open-angle glaucoma or ocular hypertension and baseline IOP between 18 and 34 mmHg will be enrolled. Study medication is administered for 14 consecutive days and 24-hour intraocular pressure (IOP) profiles will be measured to compare daytime and nighttime effects; total participation including any required washout may be up to 10 weeks. The within-patient contralateral design and masking allow direct comparison of the two treatments while minimizing inter-subject variability.
Who should consider this trial
Good fit: Adults (≥18 years) with bilateral open-angle glaucoma or ocular hypertension, baseline IOP of 18–34 mmHg, and adequate visual acuity who can attend in-person visits and follow study procedures are ideal candidates.
Not a fit: Patients with angle-closure glaucoma, very advanced glaucoma, IOP outside the 18–34 mmHg range, recent ocular surgery, or inability to attend Mayo Clinic in Rochester visits are unlikely to benefit from or be eligible for this comparison.
Why it matters
Potential benefit: If successful, the combination drop could provide better 24-hour IOP control than latanoprost alone, potentially lowering the risk of glaucoma progression.
How similar studies have performed: Previous randomized trials of the netarsudil–latanoprost fixed combination have shown greater IOP lowering than latanoprost alone, and this study tests whether that advantage applies across a full 24-hour period.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Rochester, Minnesota
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Arthur J Sit, MD, MS — Mayo Clinic
- Study coordinator: Bridgette Halder
- Email: Halder.Bridgette@mayo.edu
- Phone: 507-422-2780
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.