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
Prospective, Multi-Center, Open-Label, Non-Randomized, Multi-Arm Study to Evaluate the Safety, Efficacy, and Dose Response of the Bimatoprost Drug Ring System (BIM-DRS) in Pseudophakic Patients Implanted With a Posterior Chamber Intraocular Lens (PC-IOL) and Diagnosed With Mild to Moderate Open-Angle Glaucoma (OAG) or Ocular Hypertension (OHT)
1 other identifier
interventional
24
0 countries
N/A
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jul 2026
Typical duration for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 27, 2026
CompletedFirst Posted
Study publicly available on registry
June 11, 2026
CompletedStudy Start
First participant enrolled
July 31, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2027
Study Completion
Last participant's last visit for all outcomes
March 31, 2030
June 11, 2026
June 1, 2026
7 months
May 27, 2026
June 8, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Mean IOP change from Baseline (mmHg)
Postoperative Week 2, Week 6, and Month 3.
Secondary Outcomes (5)
Mean IOP (mmHg)
Postoperative Week 2, Week 6, and Months 3, 6, 12, 18, 24, 30, and 36
Mean IOP change from Baseline (mmHg)
Postoperative Months 6, 12, 18, 24, 30, and 36
Mean IOP change from Baseline
Postoperative Months 6, 12, 18, 24, 30, and 36
Time to postoperative introduction of additional IOP-lowering medication
Postoperative Day 1, Week 2, Week 6, Month 3, Month 6, Month 12, Month 18, Month 24, Month 30, and Month 36
Number of additional IOP-lowering medications introduced
Postoperative Months 3, 6, 12, 18, 24, 30, and 36
Study Arms (4)
Bimatoprost-Drug Ring System Low Dose and Previously Implanted Commercially Available Monofocal IOL
EXPERIMENTALBimatoprost-Drug Ring System High Dose and Previously Implanted Commercially Available Monofocal IOL
EXPERIMENTALBimatoprost-Drug Ring System Low Dose with SpyGlass IOL (IOL with silicone pads (no drug))
EXPERIMENTALBimatoprost-Drug Ring System High Dose with SpyGlass IOL (IOL with silicone pads (no drug))
EXPERIMENTALInterventions
Bimatoprost-Drug Ring System Low Dose
Bimatoprost-Drug Ring System High Dose
SpyGlass Intraocular Lens with silicone pads (no drug)
Eligibility Criteria
You may qualify if:
- Diagnosis of mild to moderate open-angle glaucoma or ocular hypertension
- Pseudophakic or planned removal of cataract
- Female participants of childbearing potential must have a negative urine pregnancy test at the baseline visit and agree to the use of contraception
You may not qualify if:
- Uncontrolled systemic disease
- History of incisional/refractive corneal surgery
- Any glaucoma diagnosis other than OHT, open-angle, or pigmentary glaucoma
- History of incisional glaucoma surgery
- Other ocular diseases, pathology, or conditions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- To minimize bias, IOP will be measured by 2 observers - one observer will perform measurements (unmasked to treatment), while the second observer will record the measurements (masked to treatment)
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 27, 2026
First Posted
June 11, 2026
Study Start (Estimated)
July 31, 2026
Primary Completion (Estimated)
February 28, 2027
Study Completion (Estimated)
March 31, 2030
Last Updated
June 11, 2026
Record last verified: 2026-06