Evaluation of the Safety, Efficacy, Dose Response of the Bimatoprost Drug Ring System (BIM-DRS) in Pseudophakic Patients Diagnosed With Open Angle Glaucoma or Ocular Hypertension

Phase 1Not Yet RecruitingNCT07641296

SpyGlass Pharma, Inc.24 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Glaucoma Ocular Hypertension

Eligibility

Sex: ALLMin age: 22 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Mean IOP change from Baseline (mmHg)

Time frame: Postoperative Week 2, Week 6, and Month 3.

Secondary Outcomes

Mean IOP (mmHg)

Time frame: Postoperative Week 2, Week 6, and Months 3, 6, 12, 18, 24, 30, and 36

Mean IOP change from Baseline (mmHg)

Time frame: Postoperative Months 6, 12, 18, 24, 30, and 36

Mean IOP change from Baseline

Time frame: Postoperative Months 6, 12, 18, 24, 30, and 36

Time to postoperative introduction of additional IOP-lowering medication

Time frame: 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

Time frame: Postoperative Months 3, 6, 12, 18, 24, 30, and 36