Subjects With Open-angle Glaucoma, Pseudoexfoliative Glaucoma, or Ocular Hypertension Naïve to Medical and Surgical Therapy, Treated With Two Trabecular Micro-bypass Stents (iStent Inject) or Travoprost

Glaukos

Status and phase: Completed; Phase 4

Conditions: Open-angle Glaucoma

Treatments: Drug: Travoprost; Device: iStent inject

Study type: Interventional

Funder types: Industry

Identifiers

NCT01444040

GCF-027

Details and patient eligibility

About

Evaluation of the intraocular pressure (IOP) lowering effect of two iStent inject devices versus medical therapy in eyes of subjects with primary open-angle glaucoma, pseudoexfoliative glaucoma, or ocular hypertension naïve to medical and surgical therapy.

Full description

Evaluation of the intraocular pressure (IOP) lowering effect of two iStent inject devices versus medical therapy in eyes of subjects with primary open-angle glaucoma, pseudoexfoliative glaucoma, or ocular hypertension naïve to medical and surgical therapy.

Enrollment: 196 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Phakic study eye
• IOP ≥ 21 mmHg and ≤ 40 mmHg at the screening visit (subjects with OHT require a second screening IOP measurement

Exclusion criteria

• Aphakic or pseudophakic eyes (AC-IOLs or PC-IOLs)
• Previous usage of topical prostaglandin analogues or prior medical therapy for glaucoma

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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196 participants in 2 patient groups

iStent inject

Active Comparator group

Description:

Implantation of two iStent inject devices

Treatment:

Device: iStent inject

Drug

Active Comparator group

Description:

Travoprost drops

Treatment:

Drug: Travoprost