Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
Participants will:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bimatoprost Implant System / IOL Combination Low Dose | Experimental | Bimatoprost Implant System (Low Dose) used in combination with the SpyGlass Intraocular Lens |
|
| Bimatoprost Implant System / IOL Combination Medium Dose | Experimental | Bimatoprost Implant System (Medium Dose) used in combination with the SpyGlass Intraocular Lens |
|
| Bimatoprost Implant System / IOL Combination High Dose | Experimental | Bimatoprost Implant System (High Dose) used in combination with the SpyGlass Intraocular Lens |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bimatoprost Implant System / IOL Combination | Combination Product | Bimatoprost Implant System used in combination with the SpyGlass intraocular lens |
|
| Measure | Description | Time Frame |
|---|---|---|
| Unmedicated eyes with IOP reduction of ≥20% from Baseline to the Month 6 | The proportion of unmedicated eyes with IOP reduction of ≥ 20% from Baseline to the Month 6 exam. | From Baseline until the end of post-operative follow-up at Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in unmedicated IOP from Baseline to Month 6 | Mean change in unmedicated IOP (mmHg) from Baseline to Month 6 | From Baseline until the end of post-operative follow-up at Month 6 |
| Number of topical glaucoma medications |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | All adverse events occurring during the conduct of this study will be captured and reported. | From Screening to the end of post-operative follow-up at Month 6 |
| Supplementary Safety Parameter - BCDVA |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sr. Director, Clinical Affairs | SpyGlass Pharma, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro Oftalmológico Robles | Santa Rosa de Copán | 41101 | Honduras |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41621045 | Derived | Tan NE, Katz G, Robles M, Gupta PK, Kahook MY, Sussman G, Yoo P, Radcliffe NM. Prospective Pilot Study of Sustained Release Bimatoprost Implant with SpyGlass Intraocular Lens: 3-Year Results. Ophthalmol Ther. 2026 Feb;15(2):855-874. doi: 10.1007/s40123-026-01313-4. Epub 2026 Feb 1. |
Not provided
Not provided
This is a proof of concept trial (first in human).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Number of topical glaucoma medications used at Screening compared to Month 6
| From Screening until the end of post-operative follow-up at Month 6 |
Best Corrected Distance Visual Acuity (snellen)
| From Screening to the end of post-operative follow-up at Month 6 |
| Supplementary Safety Parameter - Slit Lamp Examination | Slit Lamp Examination Findings | From Screening to the end of post-operative follow-up at Month 6 |
| Supplementary Safety Parameter - Fundus Examination | Dilated Fundus Examination Findings | From Screening until the end of post-operative follow-up at Month 6 |
| Supplementary Safety Parameter - Pachymetry | Mean central corneal thickness (micrometers) | From Screening until the end of post-operative follow-up at Month 6 |
| Supplementary Safety Parameter - Specular Microscopy | Endothelial cell density (cells per square millimeter) | From Baseline until the end of post-operative follow-up at Month 6 |
| ID | Term |
|---|---|
| D002386 | Cataract |
| D009798 | Ocular Hypertension |
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided