Rocklatan Adds Pressure Reduction After MIGS (Minimally Invasive Glaucoma Surgery)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Rocklatan (netarsudil 0.02% and latanoprost 0.005%), Systane.
- Who it may be relevant to
- Registry conditions: Primary Open Angle Glaucoma. Basic parameters: from 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug Rocklatan (netarsudil 0.02% and latanoprost 0.005%)
Additional intraocular eye pressure lowering post-Hydrus - Drug Systane
Placebo Comparator (artificial tears)
Primary outcome measures
- Mean diurnal intraocular pressure change from baseline [Time frame: After 28 days up to 35 days post initiation of Rocklatan vs placebo comparator]
Secondary outcome measures (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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Center for Sight — Las Vegas
Identifiers
NCT: NCT07048886 · CFS-RAPRAM-101 · 96015755