An Open-Label, Phase 2 Study of the Latanoprost Punctal Plug Delivery System (L-PPDS) With Adjunctive Xalatan® Eye Drops in Subjects With Ocular Hypertension (OH) or Open-Angle Glaucoma (OAG)
Overview
- Phase
- Phase 2
- Intervention
- Latanoprost Punctal Plug Delivery System
- Conditions
- Ocular Hypertension
- Sponsor
- Mati Therapeutics Inc.
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Change from baseline in IOP measurements
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
The objective of this study is to investigate how the intraocular pressure (IOP)-lowering effect of the L-PPDS is altered by adjunctive Xalatan therapy.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Over 18 years
- •Diagnosed with bilateral Open-Angle Glaucoma or Ocular Hypertension
- •Currently on prostaglandin therapy
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
Arms & Interventions
Latanoprost Punctal Plug Delivery System followed by Xalatan
Subjects will have the Latanoprost Punctal Plug Delivery System placed for 4 week or until loss of efficacy. After removal of the Latanoprost Punctal Plug Delivery system, subjects will administer adjunctive Xalatan eye drops once daily for 2 weeks. This is a single arm study.
Intervention: Latanoprost Punctal Plug Delivery System
Latanoprost Punctal Plug Delivery System followed by Xalatan
Subjects will have the Latanoprost Punctal Plug Delivery System placed for 4 week or until loss of efficacy. After removal of the Latanoprost Punctal Plug Delivery system, subjects will administer adjunctive Xalatan eye drops once daily for 2 weeks. This is a single arm study.
Intervention: Xalatan
Outcomes
Primary Outcomes
Change from baseline in IOP measurements
Time Frame: 4 weeks