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

Phase 2Active Not RecruitingNCT06120842

SpyGlass Pharma, Inc.201 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

201

Conditions

Cataract Glaucoma Ocular Hypertension

Interventions

Bimatoprost Implant System (High Dose)DRUG

Bimatoprost Implant System (High Dose) used in combination with the SpyGlass IOL

Bimatoprost Implant System (Low Dose)DRUG

Bimatoprost Implant System (Low Dose) used in combination with the SpyGlass IOL

Timolol Maleate Ophthalmic Solution, 0.5%DRUG

Timolol Maleate Ophthalmic Solution 0.5% BID

Eligibility

Sex: ALLMin age: 22 Years

Medical Language ↔ Plain English

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

Locations (1)

Arizona Advanced Eye Research Institute

Glendale, Arizona, United States

Outcomes

Primary Outcomes

Mean IOP Reduction from Baseline (mmHg)

Time matched mean IOP reduction from Baseline (mmHg) in the study eyes at all the individual IOP timepoints

Time frame: Weeks 2 and 6, and Month 3

Secondary Outcomes

Mean IOP

Time matched mean IOP (mmHg) at Weeks 2 and 6 and Months 3, 6, 12, 18, 24, 27, 30, 33, and 36

Time frame: 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

Time frame: 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)

Time frame: 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

Time frame: Total Study Period of 36 Months

Proportion of eyes achieving BCDVA 20/40 or better

Snellen Equivalent

Time frame: Months 3, 6, and 12

Manifest refraction spherical equivalent

Manifest refraction spherical equivalent (MRSE)

Time frame: Month 3

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.