Evaluation of the Bimatoprost Implant System Used in Combination With the SpyGlass Intraocular Lens Compared to Timolol Ophthalmic Solution

Study Overview
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Brief Summary
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This trial is a randomized study to evaluate and compare two doses of the Bimatoprost Implant System used in combination with the SpyGlass IOL to Timolol Ophthalmic Solution in participants with mild to moderate open-angle glaucoma or ocular hypertension undergoing cataract surgery.

Official Title
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A Prospective, Multicenter, Randomized, Masked, Controlled Study to Evaluate the Safety, Efficacy, and Dose-response of the Bimatoprost Implant System Used in Combination With the SpyGlass IOL Compared to Timolol Maleate Ophthalmic Solution, USP, 0.5%

Conditions
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Cataract, Glaucoma, Ocular Hypertension

Intervention / Treatment
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* Drug: Bimatoprost Implant System (High Dose)
* Drug: Bimatoprost Implant System (Low Dose)
* Drug: Timolol Maleate Ophthalmic Solution, 0.5%
* Device: Commercially Available Aspheric Monofocal Non-Yellow Chromophore IOL
* Device: SpyGlass IOL


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of mild to moderate open-angle glaucoma or ocular hypertension 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, pseudoexfoliation, or pigmentary glaucoma History of incisional glaucoma surgery or intraocular injections Other ocular diseases, pathology, or conditions

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bimatoprost Implant System (High Dose) / IOL Combination<br> | Drug: Bimatoprost Implant System (High Dose)<br>* Bimatoprost Implant System (High Dose) used in combination with the SpyGlass IOL<br>Device: SpyGlass IOL<br>* SpyGlass Intraocular Lens<br>|
| Experimental: Bimatoprost Implant System (Low Dose) / IOL Combination<br> | Drug: Bimatoprost Implant System (Low Dose)<br>* Bimatoprost Implant System (Low Dose) used in combination with the SpyGlass IOL<br>Device: SpyGlass IOL<br>* SpyGlass Intraocular Lens<br>|
| Active Comparator: Timolol Maleate Ophthalmic Solution 0.5%<br> | Drug: Timolol Maleate Ophthalmic Solution, 0.5%<br>* Timolol Maleate Ophthalmic Solution 0.5% BID<br>Device: Commercially Available Aspheric Monofocal Non-Yellow Chromophore IOL<br>* Commercially Available Aspheric Monofocal Non-Yellow Chromophore Intraocular Lens<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean IOP Reduction from Baseline (mmHg) | Time matched mean IOP reduction from Baseline (mmHg) in the study eyes at all the individual IOP timepoints | Weeks 2 and 6, and Month 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean IOP | Time matched mean IOP (mmHg) at Weeks 2 and 6 and Months 3, 6, 12, 18, 24, 27, 30, 33, and 36 | Weeks 2 and 6 and Months 3, 6, 12, 18, 24, 27, 30, 33, and 36 | 
| Mean IOP Change from Baseline | Time matched mean IOP change from Baseline (mmHg) at Months 6, 12, 18, 24, 27, 30, 33, and 36 | Months 6, 12, 18, 24, 27, 30, 33, and 36 | 
| Time to postoperative introduction of IOP-lowering medications | Time (Days) to postoperative introduction of IOP-lowering medications (IOP-lowering medications other than the study treatments) | Total Study Period of 36 Months | 
| Number of IOP-lowering medications introduced postoperatively | Number of IOP-lowering medications introduced postoperatively (N) at Weeks 2 and 6, and Months 3, 6, 12, 18, 24, 27, 30, 33, and 36 | Total Study Period of 36 Months | 
| Proportion of eyes achieving BCDVA 20/40 or better | Snellen Equivalent | Months 3, 6, and 12 | 
| Manifest refraction spherical equivalent | Manifest refraction spherical equivalent (MRSE) | Month 3 |