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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-15

Study Completion Date

2026-12-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Primary Open Angle Glaucoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Placebo Comparator Systane Artificial Tears

Comparator arm is Systane artificial tears

Group Type PLACEBO_COMPARATOR

Systane

Intervention Type DRUG

Placebo Comparator (artificial tears)

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

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.

Group Type ACTIVE_COMPARATOR

Rocklatan (netarsudil 0.02% and latanoprost 0.005%)

Intervention Type DRUG

Additional intraocular eye pressure lowering post-Hydrus

Interventions

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Rocklatan (netarsudil 0.02% and latanoprost 0.005%)

Additional intraocular eye pressure lowering post-Hydrus

Intervention Type DRUG

Systane

Placebo Comparator (artificial tears)

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No