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

The purpose of this study is to evaluate the effectiveness of fluorometholone combined with sodium hyaluronate eye drops in the treatment of Sjögren syndrome.

Study Overview

• Status: Completed
• Conditions: Dry Eye Syndromes; Sjögren Syndrome

• Study Type: Observational
• Enrollment (Actual): 35

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 200031
    • Eye & ENT Hospital of Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

the people who suffered from the dry eye disease coused by the Sjögren syndrome

Description

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:

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
tear-film breakup time	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.	the enrolling day,2 weeks after treatment,4 weeks after treatment,8 weeks after treatment
Schirmer test I without anesthesia	put the Schirmer test strip into the lower conjunctival sac; close the eye for 5 minutes; read the score of the test strip	the enrolling day,2 weeks after treatment,4 weeks after treatment, 8 weeks after treatment
corneal fluorescein staining	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).	the enrolling day,2 weeks after treatment,4 weeks after treatment,8 weeks after treatment

Collaborators and Investigators

• Sponsor: Santen Pharmaceutical(China) Co.,LTD

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): November 1, 2013

Study Registration Dates

• First Submitted: December 10, 2013
• First Submitted That Met QC Criteria: December 10, 2013
• First Posted (Estimate): December 13, 2013

Study Record Updates

• Last Update Posted (Estimate): July 9, 2014
• Last Update Submitted That Met QC Criteria: July 7, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: Corticosteroids Dry Eye Sjögren syndrome inflammation treatment
• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Autoimmune Diseases; Eye Diseases; Disease; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Stomatognathic Diseases; Mouth Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Arthritis, Rheumatoid; Xerostomia; Salivary Gland Diseases; Syndrome; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Sjogren's Syndrome
• Other Study ID Numbers: FML-001 (Other Identifier: SantenChina)