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OpenTrials
Completed

NCT Number: NCT06427031

Comparing Efficacy and Safety of TJO-083 in Dry Eye Diseases Patients

In patients with dry eye syndrome, the test drug(TJO-083) or the control drug is administered for 12 weeks, and the corneal staining of each group would be evaluated. The purpose of this clinical Study is to demonstrate that the test drug is not clinically inferior to the control drug.

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Key information

Conditions

Dry Eye Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Taejoon Pharmaceutical Co., Ltd.

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female, age 20 or over
  • Has dry eye symptoms (minimum 3 months)
  • Screening both eyes, the corrected visual acuity is 0.2 or more
  • Written informed consent to participate in the trial

Exclusion criteria

  • The patients who treated with topical NSAIDs/hyaluronate sodium ophthalmic solutions within 2 weeks of randomized visits.
  • The patients with systemic or ocular disorders affecting the test results(ocular surgery, trauma, or disease) within 2 months of screening visits.
  • Intraocular pressure(IOP)> 21 mmHg
  • Patients with contact lens

Treatment and study plan

TJO-083

Drug

Diquafosol ophthalmic sodium solution, 1 drop 3 times a day

Diquafosol ophthalmic sodium solution 3%

Drug

Diquafosol ophthalmic sodium solution, 1 drop 6 times a day

Primary outcomes

  1. Change From Baseline in Corneal Staining at Week 4

    Time frame: Baseline and Week 4

    Change from Baseline in corneal staining using blue fluorescein staining procedure at Week 4.

Secondary outcomes

  1. Change From Baseline in Corneal Staining at Week 8, 12

    Time frame: Baseline and Week 8 and 12

    Change from Baseline in corneal staining using blue fluorescein staining procedure at Week 8, 12.

  2. Change From Baseline in Conjunctival Staining at Week 4, 8 and 12

    Time frame: Baseline and Week 4, 8 and 12

    Change From Baseline in Conjunctival Staining using Rose Bengal staining procedure at Week 4, 8 and 12

  3. Change From Baseline in Non-anesthetic Schirmer Test at Week 4, 8, 12

    Time frame: Baseline and Week 4, 8 and 12

    The Schirmer test without anesthesia was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac.

Sponsors and collaborators

Lead sponsor

Taejoon Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Multi-center, Randomized, Double-blinded, Active Control, Parallel, Phase 3 Trial to Evaluate the Efficacy and Safety of TJO-083 in Dry Eye Diseases Patients

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 23, 2024
Registry last updated
Apr 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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