An Open-Label, Phase 2 Study of Different Formulations (E1 and E2) of the Latanoprost Punctal Plug Delivery System (L-PPDS) in Subjects With Ocular Hypertension (OH) or Open-Angle Glaucoma (OAG)

Mati Therapeutics Inc.0 sites83 target enrollmentAugust 2009

ConditionsGlaucoma Ocular Hypertension

InterventionsFormulation E1 of L-PPDS Formulation E2 of L-PPDS

DrugsFormulation E1 of L-PPDS Formulation E2 of L-PPDS

Overview

Phase: Phase 2
Intervention: Formulation E1 of L-PPDS
Conditions: Glaucoma
Sponsor: Mati Therapeutics Inc.
Enrollment: 83
Primary Endpoint: IOP change from baseline
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 2009

End Date

May 2010

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Mati Therapeutics Inc.

Responsible Party

Sponsor

Eligibility Criteria

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