Two Trabecular Micro-bypass Stents & Postoperative Travoprost to Treat Glaucoma Subjects on Two Hypotensive Agents

• Status: Unknown status
• Trial end date: 2019-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The study objective was to evaluate the intraocular pressure (IOP) lowering effect of two iStent devices in eyes of subjects with primary open-angle glaucoma, washed out of two anti-glaucoma medications (one a Prostaglandin) prior to stent implantation.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Glaukos Corporation
• Treatments: Antihypertensive Agents; BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Tobramycin; Travoprost

Criteria

Inclusion Criteria:

Screening Exam Inclusion Criteria:

• Phakic patients or pseudophakic patients with posterior chamber intraocular lenses (PC-IOLs)

• Primary open-angle glaucoma (including pigmentary or pseudoexfoliative)

• C/D ratio ≤ 0.9

• Visual field defects, or nerve abnormality characteristic of glaucoma

• Two topical hypotensive medications at time of screening exam

• IOP > 18 mmHg and ≤ 30 mmHg (medicated) at screening exam

• Study eye BCVA 20/100 or better

• Normal angle anatomy as determined by gonioscopy

• Absence of peripheral anterior synechia (PAS), rubeosis or other angle abnormalities that could impair proper placement of stent

Baseline Exam Inclusion Criteria:

• Subject has completed appropriate medication washout

• Mean IOP > 22 mmHg and ≤ 38 mmHg after anti-glaucoma medication washout period

• A 3mmHg IOP increase over screening mean IOP

Exclusion Criteria:

Screening Exam Exclusion Criteria:

• Aphakic patients or pseudophakic patients with anterior chamber IOLs (AC-IOLs)

• Prior stent implantations (study eye)

• Traumatic, uveitic, neovascular, or angle-closure glaucoma; or glaucoma associated with vascular disorders

• Functionally significant visual field loss, including severe nerve fiber bundle defects

• Prior incisional glaucoma surgery

• Prior SLT within 90 days prior to screening

• Prior ALT

• Iridectomy or laser iridotomy

• Ineligibility for ocular hypotensive medication washout period as determined by the investigator.

• Any active corneal inflammation or edema (e.g., keratitis, keratoconjunctivitis, keratouveitis)

• Clinically significant corneal dystrophy (e.g., bullous keratopathy, Fuch's dystrophy); any guttata

• Corneal surgery (prior or anticipated) of any type (including LASIK, LASEK, PRK, etc.) that may interfere with IOP measurement reliability

• Corneal opacities that would inhibit visualization of the nasal angle

• Congenital or traumatic cataract

• Retinal or optic nerve disorders that are not associated with the existing glaucoma condition

• Elevated episcleral venous pressure such as associated with: active thyroid orbitopathy; cavernous sinus fistula; Sturge-Weber syndrome; orbital tumors; orbital congestive disease

• Clinically significant sequelae from trauma

• Chronic ocular inflammatory disease or presence of active ocular inflammation

Baseline Exam Exclusion Criteria:

• Subject did not complete medication washout

• Mean IOP < 22 mmHg or > 38 mmHg after anti-glaucoma medication washout

• Subject does not have a 3mmHg IOP increase over screening mean diurnal