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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

271 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-14

Study Completion Date

2024-07-03

Brief Summary

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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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Detailed Description

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Conditions

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Dry Eye Dry Eye Syndromes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A Multicenter, Randomized, Double-blind, Active control for Evaluating the Efficacy and Safety of the test drug(TJO-083) Compared with the control drug in Dry Eye Sydrome

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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TJO-083

TJO-083 : 1 drop 3 times a day

Group Type EXPERIMENTAL

TJO-083

Intervention Type DRUG

Diquafosol ophthalmic sodium solution, 1 drop 3 times a day

Diquas-s Ophthalmic solution 3% 0.4mL

1 drop 6 times a day

Group Type ACTIVE_COMPARATOR

Diquafosol ophthalmic sodium solution 3%

Intervention Type DRUG

Diquafosol ophthalmic sodium solution, 1 drop 6 times a day

Interventions

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TJO-083

Diquafosol ophthalmic sodium solution, 1 drop 3 times a day

Intervention Type DRUG

Diquafosol ophthalmic sodium solution 3%

Diquafosol ophthalmic sodium solution, 1 drop 6 times a day

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes