Evaluating the Efficacy and Safety of TJO-087 in Moderate to Severe 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

PHASE3

Total Enrollment

182 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-19

Study Completion Date

2023-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Dry Eye Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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TJO-087

Group Type EXPERIMENTAL

TJO-087

Intervention Type DRUG

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

Cyclosporine 0.05%

Group Type ACTIVE_COMPARATOR

Cyclosporine ophthalmic solution 0.05%

Intervention Type DRUG

Cyclosporine ophthalmic solution 0.05%, 1 drop twice/day

Interventions

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TJO-087

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

Intervention Type DRUG

Cyclosporine ophthalmic solution 0.05%

Cyclosporine ophthalmic solution 0.05%, 1 drop twice/day

Intervention Type DRUG

Eligibility Criteria

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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

* 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.

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No