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

This study has been completed.
Sponsor:
Information provided by:
Santen Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01101984
First received: April 7, 2010
Last updated: November 11, 2012
Last verified: November 2012
History of Changes
  Purpose

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


Condition Intervention
Dry Eye
 Drug: diquafosol ophthalmic solution
Drug: 0.1% sodium hyaluronate ophthalmic solution.

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official 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 －

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Santen Pharmaceutical Co., Ltd.:

Primary Outcome Measures:
  • Changes in the fluorescein and rose bengal staining score [ Time Frame: 2 weeks and 4 weeks from baseline. ] [ Designated as safety issue: No ]
    1. Changes in the fluorescein staining score at Week 4 / at the time of discontinuation (non-inferiority)
    2. Changes in the rose bengal staining score at Week 4 / at the time of discontinuation (superiority)


Secondary Outcome Measures:
  • Changes in tear film breakup time (second) [ Time Frame: 2 weeks and 4 weeks from baseline. ] [ Designated as safety issue: No ]
    Changes in tear film breakup time (second) 2 weeks, 4 week after the study / at the discontinuation


Estimated Enrollment: 400
Study Start Date: February 2010
Study Completion Date: April 2012
Arms Assigned Interventions
Experimental: DE-089
DE-089 ophthalmic solution
 Drug: diquafosol ophthalmic solution
DE-089 topical ocular application, 6 times daily for 4 weeks.
Other Name: HA
Drug: 0.1% sodium hyaluronate ophthalmic solution.
0.1% HA topical ocular application, 6 times daily for 4 weeks.
Active Comparator: HA
0.1% sodium hyaluronate ophthalmic solution
 Drug: 0.1% sodium hyaluronate ophthalmic solution.
0.1% HA topical ocular application, 6 times daily for 4 weeks.

  Eligibility

Ages Eligible for Study:   21 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01101984

Locations
China
Eye & Ear Hospital of Fudan University
Shanghai, China, 200032
Singapore
Singapore Eye Research Institute
Singapore, Singapore, 168751
Sponsors and Collaborators
Santen Pharmaceutical Co., Ltd.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01101984     History of Changes
Other Study ID Numbers: 08901
Study First Received: April 7, 2010
Last Updated: November 11, 2012
Health Authority: China: Food and Drug Administration
Singapore: Health Sciences Authority

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
 Corneal Diseases
Lacrimal Apparatus Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013