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

• Sponsor: Santen Pharmaceutical(China) Co.,LTD (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02011776
• Collaborator: (none)
• Enrollment: 35
• Location: 1
• Duration (Months): 8
• Patients Per Site Per Month: 4.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Syndromes; Sjögren Syndrome

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 35 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: A Randomized, Parallel-Group Comparison Study of Topical Corticosteroids in Dry Eye Patients With Sjögren Syndrome
• Study Start Date: Mar 1, 2013
• Actual Primary Completion Date: Aug 1, 2013
• Actual Study Completion Date: Nov 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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

3. 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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Eye & ENT Hospital of Fudan University	Shanghai		China	200031

Sponsors and Collaborators

• Santen Pharmaceutical(China) Co.,LTD

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lan Gong, Professor, Santen Pharmaceutical(China) Co.,LTD
• ClinicalTrials.gov Identifier: NCT02011776
• Other Study ID Numbers: FML-001; FML-001
• First Posted: Dec 13, 2013
• Last Update Posted: Jul 9, 2014
• Last Verified: Jul 1, 2014

• Keywords provided by Lan Gong, Professor, Santen Pharmaceutical(China) Co.,LTD: Corticosteroids Dry Eye Sjögren syndrome inflammation treatment
• Additional relevant MeSH terms: Sjogren's Syndrome; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Syndrome

Study Results

No Results Posted as of Jul 9, 2014