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NCT01037036 Clinical Trial

A Study of the L-PPDS With Adjunctive Xalatan® Eye Drops in Subjects With OH or OAG

Ocular Hypertension Clinical Trial

Official title:
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)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01037036
Other study ID # PPL GLAU 08
Secondary ID
Status Completed
Phase Phase 2
First received December 17, 2009
Last updated December 10, 2013
Start date December 2009
Est. completion date July 2010

Study information
Verified date December 2013
Source Mati Therapeutics Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 15
Est. completion date July 2010
Est. primary completion date April 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Latanoprost Punctal Plug Delivery System
To evaluate the control of IOP compared to baseline, for an experimental dose of Latanoprost Punctal Plug Delivery System for 4 week or until loss of efficacy. This is a single arm study.
• Xalatan
Subjects will administer adjunctive Xalatan eye drops once daily for 2 weeks. This is a single arm study.

Locations
Country Name City State
United States Menlo Park Menlo Park California

Sponsors (2)
Lead Sponsor Collaborator
Mati Therapeutics Inc. QLT Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change from baseline in IOP measurements 4 weeks No
See also
  Status Clinical Trial Phase
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Completed NCT02558374 - Double-masked Study of Netarsudil (AR-13324) Ophthalmic Solution in Subjects With Glaucoma or Ocular Hypertension Phase 3
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