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

NCT05618730 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-09-07

No results posted yet for this study

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).

Conditions

  • Dry Eye
  • Keratoconjunctivitis Sicca
  • Ocular Inflammation

Interventions

DEVICE

punctum plug insertion

EXP-TC delivers the anti-inflammatory drug tacrolimus that acts as inhibitor of T lymphocytes and may therefore lead to the inhibition of release of inflammatory cytokines. EXP-TC has a Pangolin design and has 3 different designs: big, medium and small with drug content ranging from 194 to 348 µg. After plug insertion preservative-free, 0.15% sodium hyaluronate (Hyabak, Théa laboratories) is taken 4 times daily.

DRUG

Eye Drops, Lubricant

Preservative-free, 0.15% sodium hyaluronate (Hyabak, Théa laboratories) 4 times daily.

Sponsors & Collaborators

  • Eximore Ltd.

    lead INDUSTRY

Principal Investigators

  • Nallely Ramos Betancourt, Dr. · Asociación para Evitar la Ceguera en México

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-29
Primary Completion
2023-12-30
Completion
2023-12-30

Countries

  • Mexico

Study Locations

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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 NCT05618730 on ClinicalTrials.gov