Evaluation of the Safety and Efficacy of the Bimatoprost Implant System Used in Combination With the SpyGlass IOL Compared to Timolol Ophthalmic Solution (Rhone)

Recruitment Status
RECRUITING
(See Contacts and Locations)Verified September 2025 by SpyGlass Pharma, Inc.
Sponsor
SpyGlass Pharma, Inc.
Information Provided by (Responsible Party)
SpyGlass Pharma, Inc.
Clinicaltrials.gov Identifier
NCT07218796
Other Study ID Numbers:
SGP-006
First Submitted
October 15, 2025
First Posted
October 19, 2025
Last Update Posted
October 19, 2025
Last Verified
September 2025

ClinicalTrials.gov processed this data on October 2025. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
CataractGlaucomaOcular Hypertension
Drug: Bimatoprost Implant SystemDrug: Timolol Maleate Ophthalmic Solution, 0.5%

Study Design

Study TypeInterventional
Actual Enrollment400 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingDouble
Primary PurposeTreatment
Official TitleA Prospective, Multicenter, Randomized, Masked, Controlled Study to Evaluate the Safety and Efficacy of the Bimatoprost Implant System (78 mcg) Used in Combination With the SpyGlass IOL Compared to Timolol Maleate Ophthalmic Solution, USP, 0.5%,
Study Start DateOctober 27, 2025
Actual Primary Completion Date3yrs 1w from now
Actual Study Completion Date5yrs 1w from now

Groups and Cohorts

Group/CohortIntervention/Treatment
Bimatoprost Implant System / IOL Combination
Drug: Bimatoprost Implant System
Bimatoprost Implant System used in combination with the SpyGlass IOL
Timolol Maleate Ophthalmic Solution 0.5%
Drug: Timolol Maleate Ophthalmic Solution, 0.5%
Timolol Maleate Ophthalmic Solution, 0.5% BID

Outcome Measures

Primary Outcome Measures
  1. Mean IOP Reduction from Baseline (mmHg)
    Time-matched mean IOP change from Baseline in the study eyes at all the individual IOP timepoints
  2. BCDVA 20/40 or better
    Study eyes achieving best corrected distance visual acuity (BCDVA) of 20/40 or better
Secondary Outcome Measures
  1. Mean IOP Reduction from Baseline (mmHg)
    Time matched mean IOP reduction from Baseline (mmHg) in the study eyes at all the individual IOP timepoints

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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, pseudoexfoliative, or pigmentary glaucoma
History of incisional glaucoma surgery or intraocular injections
Other ocular diseases, pathology, or conditions

Contacts and Locations

Sponsors and CollaboratorsSpyGlass Pharma, Inc.
Locations
R and R Eye Research, LLC | San Antonio Texas, United States, 78229
Investigators
Study Chair: Paul Yoo, OD, SpyGlass Pharma