Comparing Efficacy and Safety of TJO-083 in Dry Eye Disease 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

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-14

Study Completion Date

2023-06-30

Brief Summary

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This is a prospective randomized study compared with active control and placebo arms.

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Detailed Description

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Conditions

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Dry Eye Syndromes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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TJO-083 [Part 2]

1 drop 3 times a day

Group Type EXPERIMENTAL

TJO-083

Intervention Type DRUG

Diquafosol ophthalmic sodium solution, 1 drop 3 times a day

Placebo of TJO-083 [Part 2]

1 drop 6 times a day

Group Type PLACEBO_COMPARATOR

Placebo (vehicle)

Intervention Type OTHER

1 drop 6 times a day

Diquas-s Ophthalmic solution 3% 0.4mL [Part 2]

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

Placebo (vehicle)

1 drop 6 times a day

Intervention Type OTHER

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
* Patient who have been diagnosed with dry eye syndrome at least 6 months ago
* Screening both eyes, the corrected visual acuity is 0.2 or more
* Written informed consent to participate in the trial

Exclusion Criteria

* Screening visits within 2 months the patients with systemic or ocular disorders affected the test results (ocular surgery, trauma, or disease)
* Intraocular pressure(IOP)\> 21 mmHg

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No