- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07048886
Rocklatan Eye Drops Study for Glaucoma Patients After Minimally Invasive Surgery
This important clinical trial is evaluating whether Rocklatan eye drops can provide additional pressure reduction for glaucoma patients who've undergone a minimally invasive glaucoma surgery (MIGS) called Hydrus microstent implantation. The study compares Rocklatan against artificial tears in patients who previously had cataract surgery combined with the Hydrus procedure.
Glaucoma is a serious eye condition where increased pressure damages the optic nerve, potentially leading to vision loss. While MIGS procedures like the Hydrus microstent have revolutionized glaucoma treatment by offering safer surgical options with quicker recovery, many patients still require additional medication to control their eye pressure. This study aims to determine if adding Rocklatan - which combines two pressure-lowering medications - provides better results than artificial tears alone in these post-surgical patients.
The research involves 68 adult participants aged 40+ with mild to moderate open-angle glaucoma. All participants previously had successful cataract surgery with Hydrus microstent implantation between 3 months and 2 years before joining the study. The trial carefully monitors changes in eye pressure at different times of day (8am, 10am, and 4pm) using gold-standard measurement techniques.
Key aspects of the study include:
- Random assignment to either Rocklatan or artificial tears (Systane) groups
- Double-blind design where neither patients nor researchers know which treatment is being used
- Detailed pressure measurements before and after starting the eye drops
- Special evaluation of corneal properties using advanced technology
This Phase 4 trial is particularly valuable because it examines how well Rocklatan works in real-world clinical practice after patients have received modern MIGS treatment. As glaucoma often requires lifelong management, finding the most effective medication combinations after surgery could significantly improve patients' quality of life and vision preservation.
Why this research matters for patients:
- Many glaucoma patients undergo MIGS procedures but still need medications
- Rocklatan combines two different pressure-lowering mechanisms in one drop
- Better pressure control may slow glaucoma progression and preserve vision
- Understanding post-surgical medication needs helps optimize treatment plans
The study excludes certain patients for safety reasons, including those with severe glaucoma, certain eye conditions, or allergies to the study medication. Women who are pregnant or planning pregnancy cannot participate due to potential risks.
For glaucoma patients and caregivers, this research represents an important step in understanding how to combine surgical and medical treatments most effectively. As MIGS procedures become more common, studies like this help ophthalmologists make evidence-based decisions about postoperative care. The results could lead to better standardized protocols for managing glaucoma after minimally invasive surgery, potentially reducing the number of medications patients need to use while maintaining optimal pressure control.
Glaucoma research continues to evolve rapidly, with new surgical techniques and medications offering hope for better outcomes. This study bridges an important gap between surgical innovation and medical management, addressing a common clinical question faced by both doctors and patients after MIGS procedures. The findings may help shape future treatment guidelines and give patients more options for preserving their vision with convenient, effective treatment combinations.