Safety and Efficacy of iDose® TR With Cataract Surgery vs. Cataract Surgery Alone

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

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

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).

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.