Safety and Efficacy of Punctum Plug Delivery System in Subjects With Open-Angle Glaucoma or Ocular Hypertension

A Phase II, Randomized, Masked, Parallel-Group Study of Safety and Preliminary Efficacy of the Punctum Plug Delivery System in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension

The purpose of this study is to determine if the Punctum Plug Delivery System (PPDS) is safe and effective in controlling intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

Inclusion Criteria:

• Over 18 yrs with open-angle glaucoma or ocular hypertension
• Subjects who have a best-corrected visual acuity of 20/100 or better.

Exclusion Criteria:

• Uncontrolled medical conditions.
• Subjects who wear contact lenses.
• Subjects requiring chronic topical artificial tears, lubricants, and/or requiring any other chronic topical medications.
• Subjects who have a history of chronic or recurrent inflammatory eye disease.