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Treatment of Dry Eye Disease Using Pro-ocular™ - A Proof of Concept, Safety, and Efficacy Study

NCT04884217 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2021-05-14

No results posted yet for this study

Summary

To evaluate the safety and efficacy of 1% Pro-ocular topical gel administered twice daily for 12 weeks in treatment of Dry Eye Disease

Conditions

  • Dry Eye Syndrome
  • Keratoconjunctivitis Sicca

Interventions

DRUG

Pro-ocular™ Topical Gel

Pro-ocular™ Topical Gel 1% is applied dermally to the forehead twice-daily

DRUG

Placebo Topical Gel

Placebo is a toopical gel without active ingredient applied dermally to the forehead twice-daily

Sponsors & Collaborators

  • Glia, LLC

    collaborator INDUSTRY

  • PharmaDax Inc.

    lead INDUSTRY

Principal Investigators

  • Peichun Kuo · PharmaDax Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-20
Primary Completion
2021-10-30
Completion
2021-12-30
FDA Drug
Yes

Countries

  • Taiwan

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 NCT04884217 on ClinicalTrials.gov