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Completed

NCT Number: NCT01240382

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

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.

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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 3

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

3% DE-089 ophthalmic solution

Drug

0.1% sodium hyaluronate ophthalmic solution

Drug

Primary outcomes

  1. 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.

  2. Mean Change in Rose Bengal Staining Score From Baseline

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

    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.

Sponsors and collaborators

Lead sponsor

Santen Pharmaceutical Co., Ltd.

Industry

Registry information

Official study 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 -

Important dates

Primary completion
2008
First posted
Nov 15, 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.

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