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NCT Number: NCT06120842

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Cataract Eye Diseases Glaucoma Lens Diseases Ocular Hypertension

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Arizona Advanced Eye Research Institute

Glendale, Arizona, 85306, United States

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
  • 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

Treatment and study plan

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

Commercially Available Aspheric Monofocal Non-Yellow Chromophore IOL

Device

Commercially Available Aspheric Monofocal Non-Yellow Chromophore Intraocular Lens

SpyGlass IOL

Device

SpyGlass Intraocular Lens

Primary outcomes

  1. Mean IOP Reduction from Baseline (mmHg)

    Time frame: Weeks 2 and 6, and Month 3

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

Secondary outcomes

  1. Mean IOP

    Time frame: Weeks 2 and 6 and Months 3, 6, 12, 18, 24, 27, 30, 33, and 36

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

  2. Mean IOP Change from Baseline

    Time frame: Months 6, 12, 18, 24, 27, 30, 33, and 36

    Time matched mean IOP change from Baseline (mmHg) at Months 6, 12, 18, 24, 27, 30, 33, and 36

  3. Time to postoperative introduction of IOP-lowering medications

    Time frame: Total Study Period of 36 Months

    Time (Days) to postoperative introduction of IOP-lowering medications (IOP-lowering medications other than the study treatments)

  4. Number of IOP-lowering medications introduced postoperatively

    Time frame: Total Study Period of 36 Months

    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

  5. Proportion of eyes achieving BCDVA 20/40 or better

    Time frame: Months 3, 6, and 12

    Snellen Equivalent

  6. Manifest refraction spherical equivalent

    Time frame: Month 3

    Manifest refraction spherical equivalent (MRSE)

Other outcomes

  1. Number and Rates of Adverse Events

    Time frame: Total Study Period of 36 Months

Sponsors and collaborators

Lead sponsor

SpyGlass Pharma, Inc.

Industry

Registry information

Official study title

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%

Acronym: Tigris

Important dates

Study start
2023
Primary completion
2025
Study completion
2027
First posted
Nov 7, 2023
Registry last updated
Aug 22, 2025

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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