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Completed

NCT Number: NCT01101984

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

Safety and efficacy of DE-089 ophthalmic solution in patients with dry eye will be evaluated in comparison with sodium hyaluronate ophthalmic solution.

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Key information

Conditions

Dry Eye Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

21 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eye & Ear Hospital of Fudan University, Shanghai, China

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Who can participate

Healthy volunteers accepted: No

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

diquafosol ophthalmic solution

Drug

DE-089 topical ocular application, 6 times daily for 4 weeks.

Other names: HA

0.1% sodium hyaluronate ophthalmic solution.

Drug

0.1% HA topical ocular application, 6 times daily for 4 weeks.

Primary outcomes

  1. Changes in the fluorescein and rose bengal staining score

    Time frame: 2 weeks and 4 weeks from baseline.

    • Changes in the fluorescein staining score at Week 4 / at the time of discontinuation (non-inferiority)
    • Changes in the rose bengal staining score at Week 4 / at the time of discontinuation (superiority)

Secondary outcomes

  1. Changes in tear film breakup time (second)

    Time frame: 2 weeks and 4 weeks from baseline.

    Changes in tear film breakup time (second) 2 weeks, 4 week after the study / at the discontinuation

Sponsors and collaborators

Lead sponsor

Santen Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Randomized, Parallel- Group Comparison Study of DE-089 Ophthalmic Solution in Patients With Dry Eye (Comparison With 0.1% Sodium Hyaluronate Ophthalmic Solution) - A Multinational Study -

Important dates

Study start
2010
Study completion
2012
First posted
Apr 12, 2010
Registry last updated
Nov 14, 2012

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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