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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: BIM-DRS Low Dose, BIM-DRS High Dose, SpyGlass IOL with silicone pads (no drug).
- Who it may be relevant to
- Registry conditions: Glaucoma, Ocular Hypertension. Basic parameters: from 22 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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)
Overview
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).
Interventions
- Drug BIM-DRS Low Dose
Bimatoprost-Drug Ring System Low Dose - Drug BIM-DRS High Dose
Bimatoprost-Drug Ring System High Dose - Device SpyGlass IOL with silicone pads (no drug)
SpyGlass Intraocular Lens with silicone pads (no drug)
Primary outcome measures
- Mean IOP change from Baseline (mmHg) [Time frame: Postoperative Week 2, Week 6, and Month 3.]
Secondary outcome measures (5)
- Mean IOP (mmHg) [Time frame: Postoperative Week 2, Week 6, and Months 3, 6, 12, 18, 24, 30, and 36]
- Mean IOP change from Baseline (mmHg) [Time frame: Postoperative Months 6, 12, 18, 24, 30, and 36]
- Mean IOP change from Baseline [Time frame: Postoperative Months 6, 12, 18, 24, 30, and 36]
- Time to postoperative introduction of additional IOP-lowering medication [Time frame: 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 [Time frame: Postoperative Months 3, 6, 12, 18, 24, 30, and 36]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07641296 · SGP-201