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

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%

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06120842

Acronym

Tigris

Enrollment

201

Registered

2023-11-07

Start date

2023-10-13

Completion date

2027-11-30

Last updated

2025-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract, Glaucoma, Ocular Hypertension

Brief summary

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.

Interventions

DRUGBimatoprost Implant System (High Dose)

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

DRUGBimatoprost Implant System (Low Dose)

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

DRUGTimolol Maleate Ophthalmic Solution, 0.5%

Timolol Maleate Ophthalmic Solution 0.5% BID

DEVICECommercially Available Aspheric Monofocal Non-Yellow Chromophore IOL

Commercially Available Aspheric Monofocal Non-Yellow Chromophore Intraocular Lens

DEVICESpyGlass IOL

SpyGlass Intraocular Lens

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

22 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Mean IOP Reduction from Baseline (mmHg)	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

Measure	Time frame	Description
Mean IOP	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
Mean IOP Change from Baseline	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
Time to postoperative introduction of IOP-lowering medications	Total Study Period of 36 Months	Time (Days) to postoperative introduction of IOP-lowering medications (IOP-lowering medications other than the study treatments)
Proportion of eyes achieving BCDVA 20/40 or better	Months 3, 6, and 12	Snellen Equivalent
Manifest refraction spherical equivalent	Month 3	Manifest refraction spherical equivalent (MRSE)
Number of IOP-lowering medications introduced postoperatively	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

Other

Measure	Time frame
Number and Rates of Adverse Events	Total Study Period of 36 Months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026