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NCT Number: NCT07048886

Rocklatan Adds Pressure Reduction After MIGS (Minimally Invasive Glaucoma Surgery)

The primary objective of this study is to determine if the addition of Rocklatan post-Hydrus will provide additional intraocular pressure lowering.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Center for Sight

Las Vegas, Nevada, 89145, United States

Location contact

Clinical Research Coordinator

CONTACT

Clinical Research Manager

CONTACT

[email protected]

702-724-2005

About this study

The study is a prospective single-practice with multiple locations, single-surgeon, parallel double arm study in subjects with open angle glaucoma (OAG), who were implanted with Hydrus microstent combined with cataract surgery to be randomized to receive Rocklatan vs. Comparator (artificial tears). Unmedicated MDIOP (mean diurnal intraocular pressure) measurements will be assessed at baseline (after Hydrus, prior to study medication) and at 1-month post-initiation of Study Drop.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 40 years and older
  • Subjects who have mild to moderate Open Angle Glaucoma (OAG)
  • Subjects who have undergone uncomplicated cataract surgery and Hydrus microstent implantation > 3 months prior to screening and within the last 2 years
  • Post-Hydrus subjects on 0-2 ocular hypotensive medication classes who can safely washout (if on ocular hypotensive medications)
  • Unmedicated or washed out IOP range between 16-26 mmHg

Exclusion criteria

  • History of intraocular surgery except for uneventful refractive surgery or uncomplicated cataract surgery and hydrus microstent implantation
  • Prior Selective Laser Trabeculoplasty (SLT) within 18 months of surgery
  • Secondary glaucoma excluding pseudoexfoliation and pigmentary dispersion syndrome
  • Severe Open Angle Glaucoma
  • Narrow angles, other angle abnormalities or angle closure glaucoma
  • Allergy or intolerance to Rocklatan
  • History of corneal edema, or corneal disease or dystrophy
  • Current or history of intra-ocular infection or inflammation
  • History of retinal diseases that could affect diagnostic testing
  • Anticipated use of intra-ocular or topical steroids not associated with the study protocol
  • Pregnant, breastfeeding or planning to become pregnant during the study
  • Any condition in the opinion in the investigator that would potentially confound the results of the study

Treatment and study plan

Rocklatan (netarsudil 0.02% and latanoprost 0.005%)

Drug

Additional intraocular eye pressure lowering post-Hydrus

Systane

Drug

Placebo Comparator (artificial tears)

Primary outcomes

  1. Mean diurnal intraocular pressure change from baseline

    Time frame: After 28 days up to 35 days post initiation of Rocklatan vs placebo comparator

    After Hydrus prior to study initiation drop

Secondary outcomes

  1. Diurnal Intraocular pressure change from baseline and difference between intraocular pressure at each time point

    Time frame: After Hydrus prior to study drop and after 28 days up to 35 days post initiation of study drop for all time points 8am, 10am, 4pm (± 1 hour) between groups

    Goldmann Applanation Tonometry

Other outcomes

  1. Change in corneal hysteresis from baseline

    Time frame: Change from baseline after 28 days up to 35 days post initiation of study drop

    Ocular Response Analyzer

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Research Coordinator

CONTACT

702-724-2067

Clinical Research Manager

CONTACT

[email protected]

702-724-2005

Sponsors and collaborators

Lead sponsor

Center for Sight Las Vegas

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 3, 2025
Registry last updated
Jul 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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