Multicenter, Randomized, Double-masked, Parallel Group Trial to Evaluate the Safety and Efficacy of iDose® TR (Travoprost Intracameral Implant) in Conjunction With Cataract Surgery vs. Cataract Surgery Alone
Glaukos Corporation
Summary
This trial will evaluate the safety and IOP -lowering efficacy of administering an iDose TR (travoprost intracameral implant) in conjunction with cataract surgery compared to cataract surgery alone
Description
This is a Phase 4 randomized, double-masked, parallel group trial designed to evaluate the safety and IOP-lowering efficacy of administering iDose TR (travoprost intracameral implant 75 mcg) in conjunction with uncomplicated cataract surgery (phacoemulsification with a posterior chamber intraocular lens) compared to uncomplicated cataract surgery alone, in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).
Eligibility
- Age range
- 45+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Cataract diagnosis: clinically significant age-related cataract eligible for phacoemulsification in the study eye. * OAG or OHT diagnosis: either OAG (i.e. primary, pseudoexfoliation, or pigmentary glaucoma) or OHT in the study eye (i.e., eye to undergo cataract surgery) Exclusion Criteria: * Active corneal inflammation or edema. * Retinal disorders not associated with glaucoma.
Interventions
- Combination ProductiDose TR (travoprost intracameral implant) 75 µg in conjunction with cataract surgery
iDose TR (travoprost intracameral implant) 75 µg in conjunction with cataract surgery
- ProcedureSham procedure in conjunction with cataract surgery
Sham procedure in conjunction with cataract surgery
Location
- Glaukos Investigator SiteKenosha, Wisconsin