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

Santen

Status: Completed

Conditions: Dry Eye Syndromes; Sjögren Syndrome

Study type: Observational

Funder types: Industry

Identifiers

NCT02011776

FML-001 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 35 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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:

Trial design

35 participants in 2 patient groups

Group 1

Description:

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

Group 2

Description:

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