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Safety, Tolerability and Preliminary Efficacy of Unilateral Latanoprost-loaded Punctual Plug -EXP-LP

NCT03318146 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2017-11-28

No results posted yet for this study

Summary

Glaucoma is the most frequent cause of irreversible \& preventable blindness worldwide, affecting about 2% of the world's population in people over 40. The major risk factor, and only treatable factor in glaucoma, is increased intraocular pressure (IOP). IOP reduction can slow or arrest the progression of vision loss.

Current treatment consists of drops administered on a daily basis with unfortunately low patient compliance, increasing the chance of blindness.

Eximore's product aims to eliminate the need to apply eye drops on a daily basis and thus solves the significant problem of patient compliance.

Conditions

Interventions

DEVICE

drug delivery system

The EXP-LP sustained released formula inserted into a small punctual plug. The plug is designed to release the drug over a period of up to 6 months in a slow release profile.

DRUG

XALATAN®

one drop in the affected eye(s) once daily in the evening

Sponsors & Collaborators

  • Shaare Zedek Medical Center

    lead OTHER

Principal Investigators

  • Tal Lavi · Gsap Medical Ltd.

  • Ishay Attar, CEO · Eximore Ltd.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-01
Primary Completion
2019-06-01
Completion
2019-09-01

Countries

  • Israel

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03318146 on ClinicalTrials.gov