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

Mati Therapeutics

Status and phase: Completed; Phase 2

Conditions: Glaucoma; Ocular Hypertension

Treatments: Drug: Formulation E1 of L-PPDS; Drug: Formulation E2 of L-PPDS

Study type: Interventional

Funder types: Industry

Identifiers

NCT00967811

PPL GLAU 07

Details and patient eligibility

About

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.

Enrollment: 83 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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83 participants in 2 patient groups

1. Formulation E1

Experimental group

Description:

Formulation E1 of Latanoprost-PPDS

Treatment:

Drug: Formulation E1 of L-PPDS

2. Formulation E2

Experimental group

Description:

Formulation E2 of Latanoprost-PPDS

Treatment:

Drug: Formulation E2 of L-PPDS