Phase III Confirmatory Study of DE-089 Ophthalmic Solution in Patients With Dry Eye

Study Overview
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Brief Summary
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To investigate that the efficacy of 3% DE-089 ophthalmic solution (one drop at a time, 6 times daily, 4 weeks topical administration), in comparison to 0.1% sodium hyaluronate ophthalmic solution (0.1% HA) (one drop at a time, 6 times daily, 4 weeks topical administration), is at least non-inferior in the change in fluorescein staining score, and is superior in the change in Rose bengal score, in a multicenter, double-masked, parallel-group comparison study. Safety profile will likewise be compared.

Official Title
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Double-masked Comparison Study of DE-089 Ophthalmic Solution in Patients With Dry Eye (Multi-center Study, in Comparison to 0.1% Sodium Hyaluronate Ophthalmic Solution) - Phase III Confirmatory Study -

Conditions
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Dry Eye

Intervention / Treatment
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* Drug: 3% DE-089 ophthalmic solution
* Drug: 0.1% sodium hyaluronate ophthalmic solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Those who show: Keratoconjunctival disorder confirmed with vital dye staining Abnormal Schirmer score results Exclusion Criteria: Eye disease that needs therapy other than that for dry eye Those who need to wear contact lenses during the clinical study

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3% DE-089<br> | Drug: 3% DE-089 ophthalmic solution<br> <br> |
| Active Comparator: 0.1% HA<br> | Drug: 0.1% sodium hyaluronate ophthalmic solution<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change in Fluorescein Staining Score From Baseline | Fluorescein staining was scored according to the protocol by Shimmura et al. The cornea was divided into 3 equal zones: upper, middle, and lower. Each zone had a staining score ranging between 0 and 3 points, with minimum and maximum total staining scores ranging between 0 and 9 points. 0 is better. The degree of staining with Fluorescein dyes was scored as follows: 0 = no staining, 1= staining of less than half of the area, 2= staining of more than half of the area, 3= staining in the whole area. | Baseline and 4-week (discontinued (LOCF)) | 
| Mean Change in Rose Bengal Staining Score From Baseline | Rose bengal staining were scored according to the protocol by Shimmura et al. The ocular surface was divided into 5 zones: nasal and temporal conjunctival, and upper, middle, and lower corneal areas. A staining score between 0 and 3 points was used in each zone, with the minimum and maximum total staining scores ranging between 0 and 15 points.0 is better. The degree of staining with Rose bengal dyes was scored as follows: 0 = no staining, 1= staining of less than half of the area, 2= staining of more than half of the area, 3= staining in the whole area. | Baseline and 4-week (discontinued (LOCF)) |