Skip to main content
OpenTrials
Completed

NCT Number: NCT01276223

Evaluation of Anti-Inflammatory Treatment in Dry Eye Patients

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Dry Eye Disease Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Contact Alcon Call Center at 1-888-451-3937 for Trial Locations

Fort Worth, Texas, 76134, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Difluprednate 0.05% ophthalmic emulsion

Drug

Topical ocular steroid

Other names: DUREZOL™

Difluprednate vehicle

Other

Inactive ingredients used as Run-In and placebo comparator

Primary outcomes

  1. Mean Change From Baseline (Week 0) in Visual Analog Scale (VAS) Global Ocular Discomfort Score Over 4 Weeks

    Time frame: Baseline, up to 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).

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jan 13, 2011
Registry last updated
Mar 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.