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

NCT02011776 | Completed

• 1 other identifier: FML-001
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Eye Syndromes; Sjögren Syndrome

Keywords

Corticosteroids Dry Eye Sjögren syndrome inflammation treatment

Outcome Measures

Primary Outcomes (3)

• 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.

  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

  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).

  the enrolling day,2 weeks after treatment,4 weeks after treatment,8 weeks after treatment

Study Arms (2)

Group 1

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

Group 2

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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

the people who suffered from the dry eye disease coused by the Sjögren syndrome

You may qualify if:

• 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.

Sponsors & Collaborators

• Santen Pharmaceutical(China) Co.,LTD: lead

Study Sites (1)

Eye & ENT Hospital of Fudan University

Shanghai, 200031, China

Location

MeSH Terms

Conditions

Dry Eye Syndromes; Sjogren's Syndrome

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 8 Weeks
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 10, 2013
• First Posted: December 13, 2013
• Study Start: March 1, 2013
• Primary Completion: August 1, 2013
• Study Completion: November 1, 2013
• Last Updated: July 9, 2014

Record last verified: 2014-07

Locations

CN (1)