A Study Evaluating the Latanoprost Punctal Plug Delivery System (L-PPDS) in Subjects With Ocular Hypertension or Open-Angle Glaucoma

Phase 2

Completed

• Conditions: Open Angle Glaucoma; Ocular Hypertension
• Interventions: Drug: Latanoprost-PPDS

• Registration Number: NCT01229982
• Lead Sponsor: Mati Therapeutics Inc.

Brief Summary

The purpose of this study is to test if latanoprost punctal plugs will reduce eye pressure in subjects with ocular hypertension or open-angle glaucoma.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-10-27
• Study First Submitted QC: 2010-10-27
• Study First Posted: 2010-10-28
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Status Verified: 2013-09
• Disposition First Submitted: 2013-09-16
• Disposition First Submitted QC: 2013-09-16
• Last Update Submitted: 2013-09-16
• Disposition First Posted: 2013-09-19
• Last Update Posted: 2013-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 121

Inclusion Criteria

• Diagnosed with bilateral OH or OAG and on topical prostaglandin monotherapy bilaterally as standard of care for treatment of OH or OAG.
• Adequate IOP control on topical prostaglandin monotherapy during the past 1 month.

Exclusion Criteria

• Functionally significant vision loss, or progressive field loss within the last year.
• Contact lens wear at any time during the treatment period.
• Keratoconjunctivitis sicca requiring chronic topical artificial tears, lubricants, and/or Restasis®.
• Active lid disease (i.e., moderate or severe blepharitis, meibomianitis) that requires medical treatment.
• Subjects with ≥0.9 vertical cup or completely notched optic nerve head rim.
• Currently on chronic ocular topical medications
• Currently on any ophthalmic or systemic steroid therapy.
• Laser surgery for glaucoma within the last 3 months or 6 months for incisional surgeries.
• History of macular edema
• History of chronic/recurrent inflammatory eye disease.
• History of a non-response to topical prostaglandin therapy.
• Subjects who have epiphora.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
L-PPDS	Latanoprost-PPDS	-

Primary Outcome Measures

Name	Time	Method
IOP change from baseline at 4 weeks	Baseline to 4 Weeks	4 Weeks minus baseline

Trial Locations

Locations (1)

QLT Inc.; 🇨🇦 Vancouver, British Columbia, Canada