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

NCT07048886 | Not Yet Recruiting Phase 4 FDA Drug

• 2 other identifiers: CFS-RAPRAM-10196015755
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Primary Open Angle Glaucoma

Keywords

Primary Open Angle Glaucoma; Rocklatan

Outcome Measures

Primary Outcomes (1)

• Mean diurnal intraocular pressure change from baseline

  After Hydrus prior to study initiation drop

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

Secondary Outcomes (1)

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

  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

Other Outcomes (1)

• Change in corneal hysteresis from baseline

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

Study Arms (2)

Placebo Comparator Systane Artificial Tears

PLACEBO COMPARATOR

Comparator arm is Systane artificial tears

Drug: Systane

FDA Approved Rocklatan (netarsudil 0.02% and latanoprost 0.005%)

ACTIVE COMPARATOR

FDA approved Rocklatan (netarsudil 0.02% and latanoprost 0.005%) is a fixed dose combination of a Rho kinase inhibitor and a prostaglandin analogue indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

Drug: Rocklatan (netarsudil 0.02% and latanoprost 0.005%)

Interventions

Rocklatan (netarsudil 0.02% and latanoprost 0.005%) DRUG

Additional intraocular eye pressure lowering post-Hydrus

FDA Approved Rocklatan (netarsudil 0.02% and latanoprost 0.005%)

Systane DRUG

Placebo Comparator (artificial tears)

Placebo Comparator Systane Artificial Tears

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Center for Sight Las Vegas: lead

Study Sites (1)

Center for Sight

Las Vegas, Nevada, 89145, United States

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle

Interventions

netarsudil

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Study Officials

• Medical Director, Medical Doctor

  Center For Sight

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Research Manager

CONTACT

702-724-2005; jodi.kennedy@c4slv.com

Clinical Research Coordinator

CONTACT

702-724-2067

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2025
• First Posted: July 3, 2025
• Study Start: July 15, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 3, 2025

Record last verified: 2025-06

Locations

US (1)