Actively Recruiting

Phase 4
Age: 18Years +
All Genders
ID07325240

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

Led by Mayo Clinic · Updated on 2026-05-01

30

Participants Needed

1

Research Sites

13 weeks

Total Duration

On this page

Sponsors

M

Mayo Clinic

Lead Sponsor

A

Alcon Research

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the 24-hour effect on intraocular pressure (IOP) reduction of a fixed combination of netarsudil and latanoprost compared to latanoprost alone in adults aged 18 years and older with open angle glaucoma or ocular hypertension. This study is a phase 4, double-masked, paired-contralateral trial aimed at understanding how these treatments compare when applied in each eye of the same subject. Participants will receive netarsudil-latanoprost fixed combination eye drops in one eye and latanoprost eye drops in the other eye, each dosed once daily at night for 14 consecutive days. The total participation time may extend up to 10 weeks to include any necessary washout from prior treatments. This design allows direct comparison of the two treatments within the same individual. During the study, participants will undergo various eye examinations including visual field testing, optical coherence tomography, and dilated fundus exams to assess IOP changes. Researchers will monitor IOP changes over 24 hours, focusing on mean IOP reduction, nighttime and daytime IOP variations after two weeks of treatment. Safety and adherence will be tracked throughout, with total study involvement lasting up to 10 weeks including screening and washout periods.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of ocular hypertension or mild-to-moderate open angle glaucoma in both eyes
  • Intraocular pressure of 18 mmHg or higher but less than 34 mmHg in both eyes
  • Able and willing to provide signed informed consent
  • Able to cooperate with study examinations and attend all visits
  • Contact lens wearers must remove lenses at least 24 hours before visits
  • Best-corrected visual acuity of +0.4 logMAR units (about 20/50) or better in each eye
Not Eligible

You will not qualify if you...

  • Narrow angles (3 quadrants Grade 2 or less), angle closure, or history of angle closure in either eye
  • Severe glaucomatous damage
  • Difference in intraocular pressure between eyes greater than 4 mmHg at baseline
  • Use of more than two ocular pressure-lowering medications within 30 days before screening
  • Chronic or recurrent inflammatory eye diseases
  • Recent ocular infection or inflammation within 3 months
  • Recent ocular trauma (except minor corneal abrasion) within 6 months
  • Significant retinal diseases such as severe diabetic retinopathy or macular degeneration
  • Corneal changes preventing reliable measurements
  • High myopia greater than -6.00D or hyperopia greater than +2.00D
  • Central corneal thickness outside 480 to 620 micrometers
  • Previous eye surgeries except uncomplicated cataract surgery
  • Previous glaucoma surgeries or laser treatments except selective laser trabeculoplasty over 6 months ago
  • Severe dry eye
  • Use of ocular medications within 30 days except study-required washout and lubricating drops
  • Known allergy to study medication components
  • Significant systemic diseases interfering with the study
  • Participation in other interventional studies within 30 days
  • Recent or anticipated changes in systemic medications affecting eye pressure
  • Women who are pregnant, nursing, planning pregnancy, or not using acceptable birth control
  • Known allergies or contraindications to study medication ingredients

AI-Screening

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Your Study Journey

Screening

Duration - Up to 10 weeks including any necessary washout from prior treatment

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 14 days

Participants receive netarsudil-latanoprost fixed combination ophthalmic solution in one eye and latanoprost ophthalmic solution in the other eye once daily at night for 14 consecutive days.

Daily medication application with 1 baseline visit and follow-up visits during treatment

Trial Site Locations

Total: 1 location

1

Mayo Clinic in Rochester

Rochester, Minnesota, United States, 55905

Actively Recruiting

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Research Team

B

Bridgette Halder

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Frequently Asked Questions

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Published Research Related To This Trial

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.

Sanjay Asrani, Jason Bacharach, Edward Holland...

https://pubmed.ncbi.nlm.nih.gov/32166538

One Year of Netarsudil and Latanoprost Fixed-Dose Combination for Elevated Intraocular Pressure: Phase 3, Randomized MERCURY-1 Study.

Jacob W Brubaker, Savak Teymoorian, Richard A Lewis...

https://pubmed.ncbi.nlm.nih.gov/32768361

A Randomized, Phase 2 Study of 24-h Efficacy and Tolerability of Netarsudil in Ocular Hypertension and Open-Angle Glaucoma.

James H Peace, Hayley J McKee, Casey C Kopczynski

https://pubmed.ncbi.nlm.nih.gov/33244711

Twenty-four-hour effects of bimatoprost 0.01% monotherapy on intraocular pressure and ocular perfusion pressure.

Jonathan D Tung, Ali Tafreshi, Robert N Weinreb...

https://pubmed.ncbi.nlm.nih.gov/22918671