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A Randomized, Parallel-Group Comparison Study of Topical Corticosteroids in Dry Eye Patients With Sjögren Syndrome

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02011776
First Posted: December 13, 2013
Last Update Posted: July 9, 2014
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.
Information provided by (Responsible Party):
Lan Gong, Santen Pharmaceutical(China) Co.,LTD
  Purpose
The purpose of this study is to evaluate the effectiveness of fluorometholone combined with sodium hyaluronate eye drops in the treatment of Sjögren syndrome.

Condition
Dry Eye Syndromes Sjögren Syndrome

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration: 8 Weeks
Official Title: A Randomized, Parallel-Group Comparison Study of Topical Corticosteroids in Dry Eye Patients With Sjögren Syndrome

Resource links provided by NLM:


Further study details as provided by Lan Gong, Santen Pharmaceutical(China) Co.,LTD:

Primary Outcome Measures:
  • tear—film breakup time [ Time Frame: the enrolling day,2 weeks after treatment,4 weeks after treatment,8 weeks after treatment ]
    stain the cornea with the fluorescein; close the eye; open the eye and keep the eye open,count the seconds until the first black spot appears.

  • Schirmer test I without anesthesia [ Time Frame: the enrolling day,2 weeks after treatment,4 weeks after treatment, 8 weeks after treatment ]
    put the Schirmer test strip into the lower conjunctival sac; close the eye for 5 minutes; read the score of the test strip

  • corneal fluorescein staining [ Time Frame: the enrolling day,2 weeks after treatment,4 weeks after treatment,8 weeks after treatment ]
    Fluorescein staining scores were measured on 0-3 point scale, in each quarter of corneal zone: 0(No staining), 1(some staining), 2(Staining in more than a half of the area), 3(Staining in the whole area).


Enrollment: 35
Study Start Date: March 2013
Study Completion Date: November 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Group 1
using the 0.1% fluorometholone eye drops combined with the 0.1% sodium hyaluronate eye drops
Group 2
using the 0.5% cyclosporin A eye drops combined with 0.1% sodium hyaluronate eye drops

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
the people who suffered from the dry eye disease coused by the Sjögren syndrome
Criteria

Inclusion Criteria:

  • willing to participate in this clinical study, and signed informed consent
  • age from 18 to 70 years old,both genders are permitted
  • diagnosed as the Sjögren syndrome
  • have the symptoms and signs of dry eye disease as below:

    1. have at least 2 symptoms such as dryness,foreign body sensation ,eye strain,conjunctival congestion,secretion.The summed up score of symptoms greater than 6.
    2. the score of tear-film break up time less than 5 seconds or the score of Schirmer test less than 5mm/5min.
    3. the score of corneal fluorescein staining greater than 3.

      Exclusion Criteria:

  Contacts and Locations
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): NCT02011776


Locations
China
Eye & ENT Hospital of Fudan University
Shanghai, China, 200031
Sponsors and Collaborators
Santen Pharmaceutical(China) Co.,LTD
  More Information

Responsible Party: Lan Gong, Professor, Santen Pharmaceutical(China) Co.,LTD
ClinicalTrials.gov Identifier: NCT02011776     History of Changes
Other Study ID Numbers: FML-001
FML-001 ( Other Identifier: SantenChina )
First Submitted: December 10, 2013
First Posted: December 13, 2013
Last Update Posted: July 9, 2014
Last Verified: July 2014

Keywords provided by Lan Gong, Santen Pharmaceutical(China) Co.,LTD:
Corticosteroids Dry Eye Sjögren syndrome inflammation treatment

Additional relevant MeSH terms:
Sjogren's Syndrome
Syndrome
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Disease
Pathologic Processes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Arthritis, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Xerostomia
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases