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Open Angle GlaucomaPhase 4NCT07325240

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

A Phase 4 study testing Netarsudil 0.02%/latanoprost 0.005% fixed dose combination ophthalmic solution and Latanoprost 0.005% Ophthalmic Solution in people with Open Angle Glaucoma and Ocular Hypertension, run by Mayo Clinic at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Open Angle Glaucoma, Ocular Hypertension
What is being tested?
Netarsudil 0.02%/latanoprost 0.005% fixed dose combination ophthalmic solution and Latanoprost 0.005% Ophthalmic Solution
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
21 Nov 2025to Oct 2027
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 26Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site, 1 recruiting
  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

    Bridgette Halder, 507-422-2780

    Arthur J Sit, MD, MS

    Recruiting

Other trials in United States

About this study

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

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).

Read the detailed description

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.

Being tested
Netarsudil 0.02%/latanoprost 0.005% fixed dose combination ophthalmic solution, Latanoprost 0.005% Ophthalmic Solution
Medical subject headings
Glaucoma, Open-Angle, Ocular Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Netarsudil 0.02%/latanoprost 0.005% fixed dose combination ophthalmic solutionDrug

    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

  • Latanoprost 0.005% Ophthalmic SolutionDrug

    latanoprost 0.005% solution will be applied in the contralateral eye, once daily, QD (PM) for 14 days

Study groups in NCT07325240
Study groupRoleWhat they receive
netarsudil-latanoprost armExperimentalNot described
Receives: Drug: Netarsudil 0.02%/latanoprost 0.005% fixed dose combination ophthalmic solution
latanoprost armActive comparatorNot described
Receives: Drug: Latanoprost 0.005% Ophthalmic Solution

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in mean Intraocular Pressure (IOP)

    Change in mean IOP from baseline at each time point for Latanoprost

    Measured: Change in mean IOP after 2 weeks of treatment with Latanoprost compared to baseline

  2. Change in mean IOP

    Change in mean IOP from baseline at each time point for Rocklatan

    Measured: Change in mean IOP after 2 weeks of treatment with Rocklatan compared to baseline

  3. Change in mean IOP

    Change in mean IOP from Latanoprost at each time point for Rocklatan

    Measured: 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

Secondary outcomes (4)
  1. Change in mean nocturnal IOP

    Change in mean nocturnal IOP (both absolute and % change) from baseline for Latanoprost

    Measured: 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

  2. Change in mean nocturnal IOP

    Change in mean nocturnal IOP (both absolute and % change) from baseline for Rocklatan

    Measured: 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

  3. Change in mean diurnal IOP

    Change in mean diurnal IOP (both absolute and % change) from baseline for Latanoprost

    Measured: 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

  4. Change in mean diurnal IOP

    Change in mean diurnal IOP (both absolute and % change) from baseline for Rocklatan

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jan 2026
  2. Study start21 Nov 2025
  3. Primary completionJul 2027 (estimated)
  4. Study completionOct 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07325240
Sponsor's protocol ID
25-012250
Status last verified
Apr 2026
First submitted
1 Jan 2026
Last updated
1 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Nelson W, Tong YL, Lee JK, Halberg F. Methods for cosinor-rhythmometry. Chronobiologia. 1979 Oct-Dec;6(4):305-23. No abstract available.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 16765686
  • Brubaker RF. Flow of aqueous humor in humans [The Friedenwald Lecture]. Invest Ophthalmol Vis Sci. 1991 Dec;32(13):3145-66.

    PubMed 1748546
  • Tung JD, Tafreshi A, Weinreb RN, Slight JR, Medeiros FA, Liu JH. Twenty-four-hour effects of bimatoprost 0.01% monotherapy on intraocular pressure and ocular perfusion pressure. BMJ Open. 2012 Aug 23;2(4):e001106. doi: 10.1136/bmjopen-2012-001106. Print 2012.

    PubMed 22918671
  • Liu JH, Medeiros FA, Slight JR, Weinreb RN. Diurnal and nocturnal effects of brimonidine monotherapy on intraocular pressure. Ophthalmology. 2010 Nov;117(11):2075-9. doi: 10.1016/j.ophtha.2010.03.026. Epub 2010 Jul 21.

    PubMed 20663566
  • Liu JH, Medeiros FA, Slight JR, Weinreb RN. Comparing diurnal and nocturnal effects of brinzolamide and timolol on intraocular pressure in patients receiving latanoprost monotherapy. Ophthalmology. 2009 Mar;116(3):449-54. doi: 10.1016/j.ophtha.2008.09.054. Epub 2009 Jan 20.

    PubMed 19157559
  • Liu JH, Kripke DF, Weinreb RN. Comparison of the nocturnal effects of once-daily timolol and latanoprost on intraocular pressure. Am J Ophthalmol. 2004 Sep;138(3):389-95. doi: 10.1016/j.ajo.2004.04.022.

    PubMed 15364220
  • Sit AJ, Gupta D, Kazemi A, McKee H, Challa P, Liu KC, Lopez J, Kopczynski C, Heah T. Netarsudil Improves Trabecular Outflow Facility in Patients with Primary Open Angle Glaucoma or Ocular Hypertension: A Phase 2 Study. Am J Ophthalmol. 2021 Jun;226:262-269. doi: 10.1016/j.ajo.2021.01.019. Epub 2021 Jan 29.

    PubMed 33524367
  • Kazemi A, McLaren JW, Kopczynski CC, Heah TG, Novack GD, Sit AJ. The Effects of Netarsudil Ophthalmic Solution on Aqueous Humor Dynamics in a Randomized Study in Humans. J Ocul Pharmacol Ther. 2018 Jun;34(5):380-386. doi: 10.1089/jop.2017.0138. Epub 2018 Feb 22.

    PubMed 29469601

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Netarsudil 0.02%/latanoprost 0.005% fixed dose combination ophthalmic solution and Latanoprost 0.005% Ophthalmic Solution in people with Open Angle Glaucoma and Ocular Hypertension, run by Mayo Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Bridgette Halder (507-422-2780, Halder.Bridgette@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in mean Intraocular Pressure (IOP) (time frame: Change in mean IOP after 2 weeks of treatment with Latanoprost compared to baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07325240, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.

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