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

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.

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Key information

Conditions

Dry Eye Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Santen study sites

Osaka, Japan

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DE-089 ophthalmic solution

Drug

Placebo Ophthalmic Solution

Drug

Primary outcomes

Mean Change in Fluorescein Staining Score From Baseline

Time frame: Baseline and 4-week (discontinued(LOCF))

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.

Sponsors and collaborators

Lead sponsor

Santen Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Primary completion: 2006
First posted: Aug 26, 2010
Registry last updated: Aug 13, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed