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

Glaucoma Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00967811
• Other study ID #: PPL GLAU 07
• Status: Completed
• Phase: Phase 2
• First received: August 27, 2009
• Last updated: September 16, 2013
• Start date: August 2009
• Est. completion date: May 2010

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 the safety and preliminary efficacy of two formulations of the Latanoprost-PPDS in subjects with ocular hypertension or open-angle glaucoma.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Glaucoma
• Hypertension
• Ocular Hypertension

Intervention

Drug:
• Formulation E1 of L-PPDS
Control of IOP compared to baseline for Formulation E1 of the experimental dose of Latanoprost-PPDS for 6 weeks or until loss of efficacy.
• Formulation E2 of L-PPDS
Control of IOP compared to baseline for Formulation E2 of 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.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IOP change from baseline		12 weeks	No