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

NCT01189032 | Completed Phase 2 Results

• 1 other identifier: 00890404
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (1)

• 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))

Study Arms (3)

High concentration

EXPERIMENTAL

Drug: DE-089 ophthalmic solution

Low concentration

EXPERIMENTAL

Drug: DE-089 ophthalmic solution

Placebo

PLACEBO COMPARATOR

Drug: Placebo ophthalmic solution

Interventions

DE-089 ophthalmic solution DRUG

High concentration

Placebo ophthalmic solution DRUG

Placebo

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Those who show:
• Keratoconjunctival disorder confirmed with vital dye staining
• Abnormal Schirmer score results

You may not qualify if:

• Eye disease that needs therapy other than that for dry eye
• Those who need to wear contact lenses during the clinical study

Sponsors & Collaborators

• Santen Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Santen study sites

Osaka, Osaka, Japan

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Results Point of Contact

• Title: General Manager of Clinical Development Group
• Organization: Santen Pharmaceutical Co., Ltd.

clinical@santen.co.jp

+81-6-4802-9341

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 24, 2010
• First Posted: August 26, 2010
• Primary Completion: July 1, 2006
• Last Updated: August 13, 2014
• Results First Posted: August 8, 2014

Record last verified: 2014-08

Locations

JP (1)