Status:
COMPLETED
A Study Evaluating the Latanoprost Punctal Plug Delivery System (L-PPDS) in Subjects With Ocular Hypertension or Open-Angle Glaucoma
Lead Sponsor:
Mati Therapeutics Inc.
Conditions:
Ocular Hypertension
Open Angle Glaucoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
121 Patients enrolled
Trial Details
Trial ID
NCT01229982
Start Date
October 1 2010
End Date
August 1 2011
Last Update
September 19 2013
Active Locations (1)
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1
QLT Inc.
Vancouver, British Columbia, Canada, V5T 4T5