NCT01229982CompletedPhase 2
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)
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Mati Therapeutics Inc.
- Enrollment
- 121
- Locations
- 1
- Primary Endpoint
- IOP change from baseline at 4 weeks
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
L-PPDS
Experimental
Intervention: Latanoprost-PPDS (Drug)
Outcomes
Primary Outcomes
IOP change from baseline at 4 weeks
Time Frame: Baseline to 4 Weeks
4 Weeks minus baseline
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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