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NCT Number: NCT07641296

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

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).

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Key information

Conditions

Glaucoma Eye Diseases Ocular Hypertension

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BIM-DRS Low Dose

Drug

Bimatoprost-Drug Ring System Low Dose

BIM-DRS High Dose

Drug

Bimatoprost-Drug Ring System High Dose

SpyGlass IOL with silicone pads (no drug)

Device

SpyGlass Intraocular Lens with silicone pads (no drug)

Primary outcomes

  1. Mean IOP change from Baseline (mmHg)

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

Secondary outcomes

  1. Mean IOP (mmHg)

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

  2. Mean IOP change from Baseline (mmHg)

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

  3. Mean IOP change from Baseline

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

  4. 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

  5. Number of additional IOP-lowering medications introduced

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

Study contacts

Contact information is provided by the study sponsor or research team.

Sr. Vice President, Clinical Development

CONTACT

[email protected]

949-284-6904

Sponsors and collaborators

Lead sponsor

SpyGlass Pharma, Inc.

Industry

Registry information

Official study title

Prospective, Multi-Center, Open-Label, Non-Randomized, Multi-Arm Study to Evaluate the Safety, Efficacy, and Dose Response of the Bimatoprost Drug Ring System (BIM-DRS) in Pseudophakic Patients Implanted With a Posterior Chamber Intraocular Lens (PC-IOL) and Diagnosed With Mild to Moderate Open-Angle Glaucoma (OAG) or Ocular Hypertension (OHT)

Important dates

Study start
2026
Primary completion
2027
Study completion
2030
First posted
Jun 11, 2026
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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