A Phase 2 Study of the Latanoprost Punctal Plug Delivery System in Subjects With Ocular Hypertension or Open-Angle Glaucoma

Glaucoma Clinical Trial

Official title:

A Partially Masked, Phase 2 Study of the Latanoprost Punctal Plug Delivery System (L-PPDS) in Subjects With Ocular Hypertension (OH) or Open-Angle Glaucoma (OAG)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00855517
• Other study ID #: PPL GLAU 06
• Status: Withdrawn
• Phase: Phase 2
• First received: March 2, 2009
• Last updated: September 16, 2013
• Start date: March 2009
• Est. completion date: July 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 purpose of this study is to evaluate IOP response to experimental dose of Latanoprost- PPDS in subjects with ocular hypertension or open-angle glaucoma.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Over 18 yrs of age with ocular hypertension or open-angle glaucoma

• Subjects who have a best corrected visual acuity of 20/100 or better

Exclusion Criteria:

• Subjects who wear contact lenses.

• Uncontrolled medical conditions

• Subjects requiring chronic topical artifical tears, lubricants and/or requiring any other chronic topical medications

• Subjects who have a history of chronic or recurrent inflammatory eye disease

Study Design

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

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension

Intervention

Drug:
• Latanoprost-PPDS
Control of IOP compared to baseline for the experimental dose of Latanoprost-PPDS for 6 weeks or until loss of efficacy.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mati Therapeutics Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IOP change from baseline		6 weeks	No