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NCT00821002 Clinical Trial

A Phase 2 Study of Punctal Placement of the Latanoprost Punctal Plug Delivery System (L-PPDS)

Ocular Hypertension Clinical Trial

Official title:
An Open-Label, Phase 2 Study of Punctal Placement of the Latanoprost Punctal Plug System (L-PPDS) in Subjects With Ocular Hypertension (OH) or Open-Angle Glaucoma (OAG)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00821002
Other study ID # PPL GLAU 05
Secondary ID
Status Completed
Phase Phase 2
First received January 8, 2009
Last updated September 16, 2013
Start date January 2009
Est. completion date November 2009

Study information
Verified date September 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 study objective is to compare IOP and safety outcomes based on plug placement (upper or lower puncta).

Recruitment information / eligibility
Status Completed
Enrollment 32
Est. completion date November 2009
Est. primary completion date November 2009
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

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Latanoprost
Comparison of punctal plug placement between upper and lower puncta

Locations
Country Name City State
n/a

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 Intraocular pressure change from baseline (mmHg) 6 weeks Yes
Secondary Number of subjects with adverse events 6 weeks Yes
See also
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