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

• Status: Completed
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mati Therapeutics Inc.
• Treatments: Latanoprost

Criteria

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.