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

Dry Eye Syndromes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02011776
• Other study ID #: FML-001
• Secondary ID: FML-001
• Status: Completed
• Phase: N/A
• First received: December 10, 2013
• Last updated: July 7, 2014
• Start date: March 2013
• Est. completion date: November 2013

Study information

• Verified date: July 2014
• Source: Santen Pharmaceutical(China) Co.,LTD
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: November 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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:

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Keratoconjunctivitis Sicca
• Sjögren Syndrome
• Sjogren's Syndrome
• Syndrome

Locations

Country	Name	City	State
China	Eye & ENT Hospital of Fudan University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Santen Pharmaceutical(China) Co.,LTD

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes