Rocklatan Adds Pressure Reduction After MIGS (Minimally Invasive Glaucoma Surgery)
United States68 participantsStarted 2025-07-15
Plain-language summary
The primary objective of this study is to determine if the addition of Rocklatan post-Hydrus will provide additional intraocular pressure lowering.
Who can participate
Age range40 Years
SexALL
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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
What they're measuring
1
Mean diurnal intraocular pressure change from baseline
Timeframe: After 28 days up to 35 days post initiation of Rocklatan vs placebo comparator