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

Dry Eye Clinical Trial

Official title:

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 -

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01240382
• Other study ID #: 00890602
• Status: Completed
• Phase: Phase 3
• First received: November 12, 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 332
• Est. primary completion date: February 2008
• 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

• Dry Eye
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Drug:
• 3% DE-089 ophthalmic solution

• 0.1% sodium hyaluronate 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
Primary	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))	No