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

N/ACompletedNCT02011776

Santen Pharmaceutical(China) Co.,LTD35 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Dry Eye Syndromes Sjögren Syndrome

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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:

Locations (1)

Eye & ENT Hospital of Fudan University

Shanghai, China

Outcomes

Primary Outcomes

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.

Time frame: 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

Time frame: 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).

Time frame: the enrolling day,2 weeks after treatment,4 weeks after treatment,8 weeks after treatment

Data from ClinicalTrials.gov

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