Evaluation of the Safety and Efficacy of the Bimatoprost Implant System Used in Combination With the SpyGlass IOL Compared to Timolol Ophthalmic Solution (Rhine)
A 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%,
1 other identifier
interventional
400
1 country
1
Brief Summary
This trial is a randomized study to evaluate 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Oct 2025
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 15, 2025
CompletedFirst Submitted
Initial submission to the registry
October 16, 2025
CompletedFirst Posted
Study publicly available on registry
October 20, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 31, 2031
October 20, 2025
October 1, 2025
3.5 years
October 16, 2025
October 16, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Mean IOP Reduction from Baseline (mmHg)
Time-matched mean IOP change from Baseline in the study eyes at all the individual IOP timepoints
Weeks 2 and 6, and Month 3
BCDVA 20/40 or better
Study eyes achieving best corrected distance visual acuity (BCDVA) of 20/40 or better
Month 6
Secondary Outcomes (1)
Mean IOP Reduction from Baseline (mmHg)
Month 6, 9 and 12
Study Arms (2)
Bimatoprost Implant System / IOL Combination
EXPERIMENTALTimolol Maleate Ophthalmic Solution 0.5%
ACTIVE COMPARATORInterventions
Bimatoprost Implant System used in combination with the SpyGlass IOL
Timolol Maleate Ophthalmic Solution, 0.5% BID
Commercially Available Aspheric Monofocal Non-Yellow Chromophore Intraocular Lens
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Houston Eye Associates
Houston, Texas, 77025, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Paul Yoo, OD
SpyGlass Pharma
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 16, 2025
First Posted
October 20, 2025
Study Start
October 15, 2025
Primary Completion (Estimated)
March 31, 2029
Study Completion (Estimated)
March 31, 2031
Last Updated
October 20, 2025
Record last verified: 2025-10