A Study of Different Formulations of the L-PPDS in Subjects With OH or OAG

Phase 2

Completed

• Conditions: Glaucoma; Ocular Hypertension
• Interventions: Drug: Formulation E1 of L-PPDS; Drug: Formulation E2 of L-PPDS

• Registration Number: NCT00967811
• Lead Sponsor: Mati Therapeutics Inc.

Brief Summary

The purpose of this study is to evaluate the safety and preliminary efficacy of two formulations of the Latanoprost-PPDS in subjects with ocular hypertension or open-angle glaucoma.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-08-27
• Study First Submitted QC: 2009-08-27
• Study First Posted: 2009-08-28
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Disposition First Submitted: 2011-06-17
• Disposition First Submitted QC: 2011-06-27
• Disposition First Posted: 2011-06-29
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-16
• Last Update Posted: 2013-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 83

Inclusion Criteria

• Subjects over 18 years of age diagnosed 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
• Subjects who have uncontrolled medical conditions
• Subjects requiring chronic topical artificial tears, lubricants, and/or requiring any other chronic ocular topical medications
• Subjects who have a history of chronic or recurrent inflammatory eye disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1. Formulation E1	Formulation E1 of L-PPDS	Formulation E1 of Latanoprost-PPDS
2. Formulation E2	Formulation E2 of L-PPDS	Formulation E2 of Latanoprost-PPDS

Primary Outcome Measures

Name	Time	Method
IOP change from baseline	12 weeks