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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02011776

Enrollment

Registered

2013-12-13

Start date

2013-03-31

Completion date

2013-11-30

Last updated

2014-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Eye Syndromes, Sjögren Syndrome

Keywords

Corticosteroids Dry Eye Sjögren syndrome inflammation treatment

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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).

Countries

China

Outcome results