Glaucoma, Ocular Hypertension
Conditions
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).
Interventions
DRUGBIM-DRS Low Dose
Bimatoprost-Drug Ring System Low Dose
DRUGBIM-DRS High Dose
Bimatoprost-Drug Ring System High Dose
DEVICESpyGlass IOL with silicone pads (no drug)
SpyGlass Intraocular Lens with silicone pads (no drug)
Sponsors
SpyGlass Pharma, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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)
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean IOP change from Baseline (mmHg) | Postoperative Week 2, Week 6, and Month 3. |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Contacts
CONTACTSr. Vice President, Clinical Development
Outcome results
None listed