Cataract, Glaucoma, Ocular Hypertension
Conditions
Brief summary
The goal of this clinical trial is to learn if the SpyGlass Pharma Bimatoprost Implant System / IOL Combination works to treat cataracts and either ocular hypertension or glaucoma. It will also learn about the safety of the Bimatoprost Implant System / IOL Combination. The main questions it aims to answer are: * Does the Bimatoprost Implant System / IOL Combination lower the pressure inside the eye to treat ocular hypertension or glaucoma? * Does the Bimatoprost Implant System / IOL Combination correct vision after cataract surgery? * What medical problems do participants have when treated with the Bimatoprost Implant System / IOL Combination? 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 standard of care cataract surgery followed by implantation of the Bimatoprost Implant System / IOL Combination. Only one eye of each participant will be treated. * Complete post-operative follow-up visits for evaluation at Day 1, Week 1, Month 1, Month 3, and Month 6 (last study visit).
Detailed description
This is a single center, proof-of-concept, nonrandomized, multi-arm, controlled clinical trial with a 6-month participation period. The study consists of 3 cohorts of up to 10 participants each. Participants are assigned sequentially to cohorts using a nonrandomized intervention model. Participants will receive standard-of-care cataract extraction by phacoemulsification followed by implantation of the SpyGlass Bimatoprost Implant System / IOL Combination (low-dose cohort; medium-dose cohort; and high-dose cohort). The primary endpoint was measured at 6 months. There was no masking in the study design, however, a 2-person reading method was used for all IOP measurements, wherein Observer 1 adjusts the dial and is masked to the reading on the dial and Observer 2 reads and records the value on the source documentation. Participants in this clinical study are seen for the following visits: a Screening visit, an Eligibility visit (Baseline), a Day 0 or Surgery visit, and postoperative visits at Day 1, Week 1, Month 1, Month 3, and Month 6 (Figure 1). Each participant has one eye designated as the study eye.
Interventions
COMBINATION_PRODUCTBimatoprost Implant System / IOL Combination
Bimatoprost Implant System used in combination with the SpyGlass intraocular lens
Sponsors
SpyGlass Pharma, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
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 * Planned removal of cataract * Diagnosis of mild to moderate open-angle glaucoma or ocular hypertension
Exclusion criteria
* Pregnant women as confirmed via urine pregnancy test for women of child-bearing age at screening * History of incisional/refractive corneal surgery * Pseudoexfoliation, pigmentary glaucoma, traumatic, uveitic, neovascular, or angle-closure glaucoma, or glaucoma associated with vascular disorders * Other ocular diseases, pathology, or conditions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Unmedicated eyes with IOP reduction of ≥20% from Baseline to the Month 6 | From Baseline until the end of post-operative follow-up at Month 6 | The proportion of unmedicated eyes with IOP reduction of ≥ 20% from Baseline to the Month 6 exam. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean change in unmedicated IOP from Baseline to Month 6 | From Baseline until the end of post-operative follow-up at Month 6 | Mean change in unmedicated IOP (mmHg) from Baseline to Month 6 |
| Number of topical glaucoma medications | From Screening until the end of post-operative follow-up at Month 6 | Number of topical glaucoma medications used at Screening compared to Month 6 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Supplementary Safety Parameter - Fundus Examination | From Screening until the end of post-operative follow-up at Month 6 | Dilated Fundus Examination Findings |
| Adverse Events | From Screening to the end of post-operative follow-up at Month 6 | All adverse events occurring during the conduct of this study will be captured and reported. |
| Supplementary Safety Parameter - Specular Microscopy | From Baseline until the end of post-operative follow-up at Month 6 | Endothelial cell density (cells per square millimeter) |
| Supplementary Safety Parameter - Pachymetry | From Screening until the end of post-operative follow-up at Month 6 | Mean central corneal thickness (micrometers) |
| Supplementary Safety Parameter - BCDVA | From Screening to the end of post-operative follow-up at Month 6 | Best Corrected Distance Visual Acuity (snellen) |
| Supplementary Safety Parameter - Slit Lamp Examination | From Screening to the end of post-operative follow-up at Month 6 | Slit Lamp Examination Findings |
Countries
Honduras
Outcome results
None listed