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

Completed

• Conditions: Dry Eye Syndromes; Sjögren Syndrome

• Registration Number: NCT02011776
• Lead Sponsor: Santen Pharmaceutical(China) Co.,LTD

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Primary Completion: 2013-08
• Study Completion: 2013-11
• Study First Submitted: 2013-12-10
• Study First Submitted QC: 2013-12-10
• Study First Posted: 2013-12-13
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-07
• Last Update Posted: 2014-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
tear-film breakup time	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	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	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).

Trial Locations

Locations (1)

Eye & ENT Hospital of Fudan University; 🇨🇳 Shanghai, China