Evaluation of the Safety, Efficacy, Dose Response of the Bimatoprost Drug Ring System (BIM-DRS) in Pseudophakic Patients Diagnosed With Open Angle Glaucoma or Ocular Hypertension

Sponsor
SpyGlass Pharma, Inc.
Study ID
NCT07641296
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

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

Interventions

  • BIM-DRS Low Dose — DRUG
    Bimatoprost-Drug Ring System Low Dose
  • BIM-DRS High Dose — DRUG
    Bimatoprost-Drug Ring System High Dose
  • SpyGlass IOL with silicone pads (no drug) — DEVICE
    SpyGlass Intraocular Lens with silicone pads (no drug)

Study Details

The goal of this clinical trial is to learn if two different doses of the SpyGlass Bimatoprost-Drug Ring System (BIM-DRS) work to treat adult pseudophakic patients with either glaucoma or ocular hypertension. The main question it aims to answer is: Does the BIM-DRS lower the pressure inside the eye to treat glaucoma or ocular hypertension? Researchers will compare two different doses of the BIM-DRS implanted either with a pre-existing commercially available monofocal intraocular lens (IOL) or concurrently with the SpyGlass IOL (IOL with silicone pads (no drug)). Participants will: * Upon providing informed consent and successfully completing the screening visit, stop taking their IOP lowering medications in the eye to be treated. * Complete a baseline visit to further evaluate eligibility in the study eye. * Undergo surgery to implant the BIM-DRS (BIM-DRS and SpyGlass IOL for Cohorts 3 and 4). Only one eye of each participant will be treated. * Complete post-operative follow-up visits for evaluation at Day 1, Week 2, Week 6, Month 3, Month 6, Month 12, Month 18, Month 24, Month 30, and Month 36 (last study visit).

Key Dates

First listed
Jun 11, 2026
Start date
Jul 31, 2026
Status verified
Jun 2026
Primary completion
Feb 28, 2027
Completion
Mar 31, 2030

Study Design

Enrollment
24 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Bimatoprost-Drug Ring System Low Dose and Previously Implanted Commercially Available Monofocal IOL
  • Experimental: Bimatoprost-Drug Ring System High Dose and Previously Implanted Commercially Available Monofocal IOL
  • Experimental: Bimatoprost-Drug Ring System Low Dose with SpyGlass IOL (IOL with silicone pads (no drug))
  • Experimental: Bimatoprost-Drug Ring System High Dose with SpyGlass IOL (IOL with silicone pads (no drug))

Primary Outcome Measure

Mean IOP change from Baseline (mmHg) [ Time Frame: Postoperative Week 2, Week 6, and Month 3. ]

Central Contacts

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