Overview

Safety, Tolerability and Preliminary Efficacy of Tacrolimus-loaded Punctal Plug in Patients With Moderate to Severe Dry Eye Disease - Cohort B

Status:
Recruiting

Trial end date:
2023-05-30

Target enrollment:

Participant gender:

Summary

The purpose of this interventional study is to assess safety, patient tolerability, plug retention rate, and preliminary efficacy in improving the symptoms of Dry Eye Disease (DED) of EXP-TC tacrolimus releasing punctal plug. The main questions it aims to answer are: 1. The safety of using EXP-TC plug following all study adverse events 2. The number of patients with Adverse Events related to the us of EXP-LP plug 3. The number of patients discontinuing the study due to plug discomfort 4. The total patients with plugs remained during the 3-months study duration from plug insertion 5. Exploratory: change from baseline in the study eye to follow-up visits in various Dryness clinical measurements. The change of measurements from baseline will also be compared between the study and fellow control eye (receiving artificial tears only, 0.15% sodium hyaluronate).

Phase:

Phase 1

Details

Lead Sponsor:

Eximore Ltd.

Treatments:

Lubricant Eye Drops
Ophthalmic Solutions