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Status unknownNCT05245604Updated Feb 18, 2022

Evaluating the Efficacy and Safety of TJO-087 in Moderate to Severe Dry Eye Disease Patients

A Phase 3 interventional study of TJO-087 and Cyclosporine ophthalmic solution 0.05% in Dry Eye Syndrome, sponsored by Taejoon Pharmaceutical Co., Ltd.. Status unknown at 1 site in Korea, Republic of. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2022-02-18.

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

The sponsor has not verified this record recently (last verified Feb 2022), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 1 year 7 months after the study started (first participant enrolled Jun 2020, registered Feb 2022).
Phase
Phase 3
Study type
Interventional
Enrollment
182
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study summary

The purpose of this clinical study is to prove that the test drug (TJO-087) is not clinically inferior to the control drug after 32 weeks of administration to patients with suppressed tear production due to moderate or severe dry eye syndrome.

02

Conditions studied

  • Dry Eye Syndrome
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 planned enrollment of 182 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 and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Male or female, age 20 or over
  • Patients with moderate to severe dry eye
  • Screening both eyes, the corrected visual acuity is 0.2 or more
  • Written informed consent to participate in the trial

Exclusion criteria

Exclusion Criteria:

  • Screening visits within 2 weeks who treated with topical NSAIDs/hyaluronate sodium ophthalmic solutions
  • Screening visits within 2 months the patients with systemic or ocular disorders affected the test results (ocular surgery, trauma, or disease)
  • Intraocular pressure(IOP)> 25 mmHg
  • Patient using or to use punctual plug within 1 months.
  • Patients with contact lens.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
182 participants (estimated)

Study arms

  • Experimental
    TJO-087

    Drug: TJO-087

  • Active comparator
    Cyclosporine 0.05%

    Drug: Cyclosporine ophthalmic solution 0.05%

Interventions

  • DrugTJO-087

    Cyclosporine ophthalmic nano-emulsion 0.08%, 1 drop once daily

  • DrugCyclosporine ophthalmic solution 0.05%

    Cyclosporine ophthalmic solution 0.05%, 1 drop twice/day

06

What researchers measure

Primary outcomes

  1. Change From Baseline in Non-anesthetic Schirmer Test at Week 32

    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 32

Secondary outcomes

  1. Change From Baseline in Non-anesthetic Schirmer Test at Week 8, 16, 24

    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, Week 8, 16 and 24

  2. Change From Baseline in Corneal Fluorescein Staining Score at Week 8, 16, 24 and 32

    Change from Baseline in corneal staining of the worse eye using blue fluorescein staining procedure.

    Time frame: Baseline, Week 8, 16, 24 and 32

07

Study locations

1 of 1 sites recruiting
  • Hyo Myung, Kim
    Seoul, Korea, Republic of
    • Hyo Myung Kim, MD, PhD · Contact
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 18, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05245604
Lead sponsor
Taejoon Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Feb 18, 2022
Start date
Jun 19, 2020
Primary completion
Aug 2022 (estimated)
Completion
Apr 2023 (estimated)
Last update
Feb 18, 2022

Study contacts

Sukyoung Kwon
Contact
skkwon@taejoon.co.kr
82-2-799-0184
Hyo Myung Kim, MD, PhD
principal investigator · Korea University Anam Hospital

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 status unknown, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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