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NCT01189032 Clinical Trial

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

Dry Eye Clinical Trial

Official title:
Dose-Response Study of DE-089 Ophthalmic Solution in Patients With Dry Eye -Late Phase II Confirmatory Study-

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01189032
Other study ID # 00890404
Secondary ID
Status Completed
Phase Phase 2
First received August 24, 2010
Last updated August 8, 2014

Study information
Verified date August 2014
Source Santen Pharmaceutical Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and Welfare
Study type Interventional

Clinical Trial Summary

Dose response related to efficacy and safety of DE-089 ophthalmic solution are examined in patients with dry eye, using a multicenter, randomized, double-blind, parallel group comparison study, and the optimal concentration is determined.

Recruitment information / eligibility
Status Completed
Enrollment 320
Est. completion date
Est. primary completion date July 2006
Accepts healthy volunteers
Gender Both
Age group 20 Years and older
Eligibility 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

Study Design

N/A

Related Conditions & MeSH terms

Intervention

Drug:
• DE-089 ophthalmic solution

• DE-089 ophthalmic solution

• Placebo ophthalmic solution

Locations
Country Name City State
Japan Santen study sites Osaka

Sponsors (1)
Lead Sponsor Collaborator
Santen Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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)) No
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