Study of the Effects of Artificial Tears on the Response to the Latanoprost Punctal Plug Delivery System in Subjects With Ocular Hypertension or Open-Angle Glaucoma

Mati Therapeutics

Status and phase: Completed; Phase 2

Conditions: Glaucoma; Ocular Hypertension

Treatments: Drug: Latanoprost punctal plug; Drug: artificial tears preserved with Benzalkonium Chloride

Study type: Interventional

Funder types: Industry

Identifiers

NCT00845299

PPL GLAU 04

Details and patient eligibility

About

The purpose of this study is to determine the effect of artificial tears preserved with Benzalkonium Chloride (AT-BAK) on the IOP response to the L-PPDS and to evaluate the safety of the L-PPDS in subjects with OH or OAG following treatment.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Over 18 years 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 with a known sensitivity to latanoprost, BAK, or any other products required for the study
• Subjects requiring chronic topical artificial tears, lubricants, and/or requiring any other chronic topical medications.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

1

Experimental group

Description:

Latanoprost punctal plug and use of artificial tears containing Benzalkonium Chloride

Treatment:

Drug: Latanoprost punctal plug

Drug: artificial tears preserved with Benzalkonium Chloride

2

Experimental group

Description:

Latanoprost punctal plug only

Treatment:

Drug: Latanoprost punctal plug