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.

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Key information

Conditions

Dry Eye Syndromes Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Eye Diseases Immune System Diseases Joint Diseases Lacrimal Apparatus Diseases Mouth Diseases Musculoskeletal Diseases Rheumatic Diseases Salivary Gland Diseases Sjogren's Syndrome Sjögren Syndrome Skin and Connective Tissue Diseases Stomatognathic Diseases Xerostomia

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Eye & ENT Hospital of Fudan University

Shanghai, 200031, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:

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.
the score of tear-film break up time less than 5 seconds or the score of Schirmer test less than 5mm/5min.
the score of corneal fluorescein staining greater than 3.

Exclusion criteria

Treatment and study plan

Primary outcomes

tear-film breakup time

Time frame: 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

Time frame: 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

Time frame: 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).

Sponsors and collaborators

Lead sponsor

Santen Pharmaceutical(China) Co.,LTD

Industry

Registry information

Important dates

Study start: 2013
Primary completion: 2013
Study completion: 2013
First posted: Dec 13, 2013
Registry last updated: Jul 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed