Evaluation of Anti-Inflammatory Treatment in Dry Eye Patients

Dry Eye Disease Clinical Trial

Official title:

A Multi-Center, Randomized, Double-Masked Evaluation of Anti-Inflammatory Treatment in Patients With Dry Eye

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01276223
• Other study ID #: C-10-078
• Status: Completed
• Phase: Phase 2
• First received: January 11, 2011
• Last updated: March 8, 2013
• Start date: February 2011
• Est. completion date: January 2012

Study information

• Verified date: March 2013
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study was to determine if difluprednate ophthalmic emulsion is effective in reducing the ocular symptoms of dry eye disease, as measured by a global Visual Analog Scale (VAS) discomfort score.

Description:

Following Run-In, patients qualifying for treatment were randomized 1:1 to receive Durezol (experimental group) or Vehicle (control group) for 5 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 722
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Normal subjects:

• No known history of dry eye disease.

• Non-contact lens wearer.

• No current use of artificial tears or any other dry eye treatment.

OR

Dry eye patients:

• At least a 6 month history of dry eye.

• Non-contact lens wearer.

• Uses artificial tears.

• Experiences persistent ocular discomfort.

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• The presence of any acute infectious or non-infectious ocular conditions in either eye within 1 month of Visit 1.

• Severe Sjogren's Syndrome.

• Lid function abnormalities.

• Use of steroids, tetracycline, doxycycline, etc., within 30 days of Visit 1.

• History of corneal surgery including refractive surgeries.

• History of glaucoma or ocular hypertension

• Other protocol-defined exclusion criteria may apply.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dry Eye Disease
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

Drug:
• Difluprednate 0.05% ophthalmic emulsion
Topical ocular steroid

Other:
• Difluprednate vehicle
Inactive ingredients used as Run-In and placebo comparator

Locations

Country	Name	City	State
United States	Contact Alcon Call Center at 1-888-451-3937 for Trial Locations	Fort Worth	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change From Baseline (Week 0) in Visual Analog Scale (VAS) Global Ocular Discomfort Score Over 4 Weeks	A Visual Analog Scale (VAS) was used by the subject to assess ocular discomfort, both frequency and severity, at baseline (pre-treatment) and weekly thereafter for 4 additional weeks. Each scale was 100 millimeters (mm) in length. The VAS score was calculated by measuring the length in mm from the start of the line to the intersection point of the vertical mark made by the subject. The Global Ocular Discomfort Score is a composite of the two VAS scores, ranging from 0 (very mildly) to 100 (very severely uncomfortable).	Baseline, up to 4 weeks	No