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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01189032
Recruitment Status : Completed
First Posted : August 26, 2010
Results First Posted : August 8, 2014
Last Update Posted : August 13, 2014
Sponsor:
Information provided by:
Santen Pharmaceutical Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
Dry Eye Drug: DE-089 ophthalmic solution Drug: Placebo ophthalmic solution Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 320 participants
Official Title: Dose-Response Study of DE-089 Ophthalmic Solution in Patients With Dry Eye -Late Phase II Confirmatory Study-
Actual Primary Completion Date : July 2006

Arm Intervention/treatment
Experimental: High concentration Drug: DE-089 ophthalmic solution
Experimental: Low concentration Drug: DE-089 ophthalmic solution
Placebo Comparator: Placebo Drug: Placebo ophthalmic solution



Primary Outcome Measures :
  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.




Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01189032


Locations
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Japan
Santen study sites
Osaka, Japan
Sponsors and Collaborators
Santen Pharmaceutical Co., Ltd.

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ClinicalTrials.gov Identifier: NCT01189032    
Other Study ID Numbers: 00890404
First Posted: August 26, 2010    Key Record Dates
Results First Posted: August 8, 2014
Last Update Posted: August 13, 2014
Last Verified: August 2014
Additional relevant MeSH terms:
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Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Ophthalmic Solutions
Pharmaceutical Solutions