Actively Recruiting
Efficacy and Tolerability of Simbrinza and Rocklatan Compared to Cosopt and Latanoprost for Mild to Moderate Open-Angle Glaucoma
Led by Prairie Eye Center · Updated on 2025-05-15
70
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
P
Prairie Eye Center
Lead Sponsor
S
Sengi
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating adults with mild to moderate open-angle glaucoma (OAG) who have been using a combination of Cosopt and Latanoprost eye medications for at least one month. This phase 4, randomized study compares the effectiveness and tolerability of two treatment combinations: Simbrinza and Rocklatan versus Cosopt and Latanoprost. The purpose is to assess how these treatments lower eye pressure in patients with this condition. Participants will be randomly assigned to receive either Simbrinza (containing brinzolamide and brimonidine tartrate) combined with Rocklatan (containing netarsudil and latanoprost) or the current standard treatment of Cosopt (dorzolamide hydrochloride and timolol maleate) combined with Latanoprost. Both treatments are given as eye drops, and the study will monitor changes in eye pressure over an 8-week period. During the study, participants will have their eye pressure measured at different times of the day to observe the effects of the treatments. Researchers will collect data on the decrease in mean diurnal intraocular pressure (IOP) from the start of the study to week 8. Safety and tolerability will also be monitored throughout the trial. The total duration of participation is approximately 8 weeks, ending with a final assessment of eye pressure reduction.
CONDITIONS
Brief Title
Efficacy of Simbrinza and Rocklatan vs Cosopt and Latanoprost
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years and older with mild to moderate open-angle glaucoma
- Currently using combination topical medication of Cosopt and Latanoprost for at least 1 month
- Evidence of optic nerve damage based on optic disc or retinal nerve fiber layer abnormalities
- Reliable and reproducible visual field abnormality consistent with glaucoma damage
- Mean diurnal intraocular pressure (IOP) between 18 mmHg and less than 28 mmHg in at least one eye
- Central corneal thickness between 450 and 650 micrometers
You will not qualify if you...
- Prior ocular procedures or eye surgery within 1 year before baseline
- History of glaucoma surgeries or laser treatments except selective laser trabeculoplasty more than 1 year before baseline
- Known allergy or hypersensitivity to study medications or related drug classes
- Presence of uncontrolled systemic diseases that may affect safety or adherence
- Significant eye diseases that would prevent accurate eye pressure measurement
- History of uncontrolled eye pressure with the study dual therapies
- Significant eye surface irritation found during examination
- Chronic use of systemic medications affecting eye pressure
- Pregnant, lactating, or planning pregnancy
- Any condition that may affect study results as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks
Participants receive one of two combination drug therapies for mild to moderate open-angle glaucoma to compare efficacy and tolerability.
Multiple visits during treatment as scheduled by the study team
Trial Site Locations
Total: 1 location
1
Prairie Eye Center
Springfield, Illinois, United States, 62704
Actively Recruiting
Research Team
J
Jennifer Lyons
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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