Evaluation of the Safety and Efficacy of the Bimatoprost Implant System Used in Combination With the SpyGlass IOL Compared to Timolol Ophthalmic Solution (Rhine)

Part of paid clinical trials in Houston, Texas.

Sponsor
SpyGlass Pharma, Inc.
Study ID
NCT07218783
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
22 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bimatoprost Implant System — DRUG
    Bimatoprost Implant System used in combination with the SpyGlass IOL
  • SpyGlass IOL — DEVICE
    SpyGlass Intraocular Lens
  • Timolol Maleate Ophthalmic Solution, 0.5% — DRUG
    Timolol Maleate Ophthalmic Solution, 0.5% BID
  • Commercial IOL — DEVICE
    Commercially Available Aspheric Monofocal Non-Yellow Chromophore Intraocular Lens

Study Details

This trial is a randomized study to evaluate the Bimatoprost Implant System used in combination with the SpyGlass IOL to Timolol Ophthalmic Solution in participants with mild to moderate open-angle glaucoma or ocular hypertension undergoing cataract surgery.

Key Dates

Start date
Oct 15, 2025
Status verified
Oct 2025
Primary completion
Mar 31, 2029
Completion
Mar 31, 2031

Study Design

Enrollment
400 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Bimatoprost Implant System / IOL Combination
  • Active Comparator: Timolol Maleate Ophthalmic Solution 0.5%

Primary Outcome Measure

Mean IOP Reduction from Baseline (mmHg) [ Time Frame: Weeks 2 and 6, and Month 3 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Houston Eye AssociatesHoustonTexas77025
Clinical Research Coordinator
[email protected]
832-553-7100

Find similar trials in Houston, TX

By condition
Glaucoma
By specialty
Ophthalmology
By research site
Houston Eye Associates· Houston, TX

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