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

A Phase 2 Study Evaluating Safety and Efficacy of the Latanoprost Punctal Plug Delivery System (L PPDS)in Subjects With Ocular Hypertension (OH) or Open Angle Glaucoma (OAG)

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.

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.