RECRUITINGPhase 3INTERVENTIONAL
Evaluation of the Safety and Efficacy of the Bimatoprost Implant System Used in Combination With the SpyGlass IOL Compared to Timolol Ophthalmic Solution (Rhone)
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%,
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- 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
Who Should NOT Join This Trial:
- 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
DRUG
Bimatoprost Implant System
Bimatoprost Implant System used in combination with the SpyGlass IOL
DEVICE
SpyGlass IOL
SpyGlass Intraocular Lens
DRUG
Timolol Maleate Ophthalmic Solution, 0.5%
Timolol Maleate Ophthalmic Solution, 0.5% BID
DEVICE
Commercial IOL
Commercially Available Aspheric Monofocal Non-Yellow Chromophore Intraocular Lens
Locations (1)
R and R Eye Research, LLC
San Antonio, Texas, United States