Rocklatan Adds Pressure Reduction After MIGS (Minimally Invasive Glaucoma Surgery)
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 68
- Locations
- 1
- Primary Endpoint
- Mean diurnal intraocular pressure change from baseline
Study Overview
Brief Summary
The primary objective of this study is to determine if the addition of Rocklatan post-Hydrus will provide additional intraocular pressure lowering.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Placebo Comparator Systane Artificial Tears
Comparator arm is Systane artificial tears
Intervention: Systane (Drug)
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.
Intervention: Rocklatan (netarsudil 0.02% and latanoprost 0.005%) (Drug)
Outcomes
Primary Outcomes
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
- 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)