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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

35 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-03-31

Study Completion Date

2013-11-30

Brief Summary

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

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Detailed Description

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Conditions

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Dry Eye Syndromes Sjögren Syndrome

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

using the 0.1% fluorometholone eye drops combined with the 0.1% sodium hyaluronate eye drops

No interventions assigned to this group

Group 2

using the 0.5% cyclosporin A eye drops combined with 0.1% sodium hyaluronate eye drops

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No