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CompletedNCT06427031Updated Apr 22, 2025

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

A Phase 3 interventional study of TJO-083 and Diquafosol ophthalmic sodium solution 3% in Dry Eye and Dry Eye Syndromes, sponsored by Taejoon Pharmaceutical Co., Ltd.. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-22.

Sponsored by Taejoon Pharmaceutical Co., Ltd. · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Jul 2023, registered May 2024).
Phase
Phase 3
Study type
Interventional
Enrollment
271
Allocation
Randomized
Ages
20 Years to 80 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Dry Eye
  • Dry Eye Syndromes
03

In context

Dry Eye Syndromes

1,292 studies on the registry are indexed under Dry Eye Syndromes; 191 are open to participants now.

This study's enrollment of 271 is above the median of 60 across 1,077 interventional studies indexed under Dry Eye Syndromes.

Browse Dry Eye Syndromes studies →

Lead sponsor

Taejoon Pharmaceutical Co., Ltd. is the lead sponsor of 16 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
271 participants (actual)

Study arms

  • Experimental
    TJO-083

    TJO-083 : 1 drop 3 times a day

    Drug: TJO-083

  • Active comparator
    Diquas-s Ophthalmic solution 3% 0.4mL

    1 drop 6 times a day

    Drug: Diquafosol ophthalmic sodium solution 3%

Interventions

  • DrugTJO-083

    Diquafosol ophthalmic sodium solution, 1 drop 3 times a day

  • DrugDiquafosol ophthalmic sodium solution 3%

    Diquafosol ophthalmic sodium solution, 1 drop 6 times a day

06

What researchers measure

Primary outcomes

  1. Change From Baseline in Corneal Staining at Week 4

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

    Time frame: Baseline and Week 4

Secondary outcomes

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

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

    Time frame: Baseline and Week 8 and 12

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

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

    Time frame: Baseline and Week 4, 8 and 12

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

    Time frame: Baseline and Week 4, 8 and 12

07

Study locations

1 site
  • Taejoon Pharmaceutical Co., Ltd.
    Seoul, Korea, Republic of
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06427031
Lead sponsor
Taejoon Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
May 23, 2024
Start date
Jul 14, 2023
Primary completion
May 22, 2024
Completion
Jul 3, 2024
Last update
Apr 22, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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