MedTrace Logo

Safety Study of the Use of Topical Cyclosporine in the Treatment of Dry Eye Disease

NCT02004067 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2020-09-22

No results posted yet for this study

Summary

In the present study the investigators aim to determine the efficacy of an immunomodulating topical medication, compared with a topical lubricant, on the treatment of dry eye disease (DED) due to primary or secondary Sjögren's syndrome (aqueous deficient DED) and evaporative DED.

Conditions

  • Primary Sjogren Syndrome
  • Secondary Sjogren Syndrome
  • Aqueous Deficient Dry Eye Disease
  • Evaporative Dry Eye Disease

Interventions

DRUG

Restasis

Restasis is an ophthalmic emulsion containing cyclosporine 0.5 mg/mL, produced by Allergan Inc.

DRUG

Refresh Endura

Refresh Endura is a topical lubricant produced by Allergan, Inc.

Sponsors & Collaborators

  • Allergan

    collaborator INDUSTRY

  • Federal University of São Paulo

    lead OTHER

Principal Investigators

  • Rossen M Hazarbassanov, PhD · Federal University of São Paulo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2016-08-31
Completion
2016-08-31

Countries

  • Brazil

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02004067 on ClinicalTrials.gov