ClinicalTrials.gg
RecruitingNCT07325240Updated May 1, 2026

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

A Phase 4 interventional study of Netarsudil 0.02%/latanoprost 0.005% fixed dose combination ophthalmic solution and Latanoprost 0.005% Ophthalmic Solution in Open Angle Glaucoma and Ocular Hypertension, sponsored by Mayo Clinic. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-01.

Sponsored by Mayo Clinic · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Started Nov 2025; still recruiting 11 months later.
Phase
Phase 4
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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).

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.

02

Conditions studied

  • Open Angle Glaucoma
  • Ocular Hypertension
03

In context

Glaucoma, Open-Angle

924 studies on the registry are indexed under Glaucoma, Open-Angle; 117 are open to participants now.

This study's planned enrollment of 30 is below the median of 80 across 692 interventional studies indexed under Glaucoma, Open-Angle.

Browse Glaucoma, Open-Angle studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,269 studies on the registry; 672 are open to participants now.

Of its 452 completed or terminated interventional studies of FDA-regulated products, 321 (71%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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

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
  • 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 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 , calcium channel blockers, diuretics, and vasodilators
  • Women of who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of . An adult woman is considered to be of childbearing potential unless she is one year 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 to any of the ingredients in the study medications
Terms in these criteria, in plain language(8)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    netarsudil-latanoprost arm

    Drug: Netarsudil 0.02%/latanoprost 0.005% fixed dose combination ophthalmic solution

  • Active comparator
    latanoprost arm

    Drug: Latanoprost 0.005% Ophthalmic Solution

Interventions

  • DrugNetarsudil 0.02%/latanoprost 0.005% fixed dose combination ophthalmic solution

    Drug page: Netarsudil

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

06

What researchers measure

Primary outcomes

  1. Change in mean Intraocular Pressure (IOP)

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

    Time frame: 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

    Time frame: 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

    Time frame: 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

  1. Change in mean nocturnal IOP

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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

Other outcomes

  1. 24-hour IOP variability

    24-hour IOP variability based on standard deviation and range of measurements from 12 time points over a 24-hour period, and circadian amplitude from cosinor analysis of the 24-hour curve

    Time frame: During the time period of analysis, approximately 18 months

  2. Diurnal IOP variability

    Diurnal IOP variability based on standard deviation and range of measurements during the waking period

    Time frame: During the time period of analysis, approximately 18 months

  3. Nocturnal IOP variability

    Nocturnal IOP variability based on standard deviation and range of measurements during the sleeping period

    Time frame: During the time period of analysis, approximately 18 months

07

Study locations

1 of 1 sites recruiting
  • Mayo Clinic in Rochester
    Rochester, Minnesota 55905, United States
    Recruiting
    • Bridgette Halder · Contact507-422-2780
    • Arthur J Sit, MD, MS · Principal investigator
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07325240
Lead sponsor
Mayo Clinic
Collaborators
Alcon Research
Responsible party
Arthur J. Sit, M.D. (Principal Investigator, Mayo Clinic) — Principal investigator
First posted
Jan 8, 2026
Start date
Nov 21, 2025
Primary completion
Jul 2027 (estimated)
Completion
Oct 2027 (estimated)
Last update
May 1, 2026

Study contacts

Bridgette Halder
Contact
Halder.Bridgette@mayo.edu
507-422-2780
Arthur J Sit, MD, MS
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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