Evaluation of Anti-Inflammatory Treatment in Dry Eye Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01276223
First received: January 11, 2011
Last updated: March 8, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention Phase
Dry Eye Disease
Drug: Difluprednate 0.05% ophthalmic emulsion
Other: Difluprednate vehicle
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multi-Center, Randomized, Double-Masked Evaluation of Anti-Inflammatory Treatment in Patients With Dry Eye

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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).


Enrollment: 722
Study Start Date: February 2011
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Durezol
Difluprednate 0.05% ophthalmic emulsion, 1 drop to the study eye 2 times a day for 4 weeks, followed by 1 drop to the study eye once daily for 1 week to allow for tapering of the steroid exposure.
Drug: Difluprednate 0.05% ophthalmic emulsion
Topical ocular steroid
Other Name: DUREZOL™
Placebo Comparator: Vehicle
Difluprednate vehicle, 1 drop to the study eye 2 times a day for 4 weeks, followed by 1 drop to the study eye once daily for 1 week.
Other: Difluprednate vehicle
Inactive ingredients used as Run-In and placebo comparator

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01276223

Locations
United States, Texas
Contact Alcon Call Center at 1-888-451-3937 for Trial Locations
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01276223     History of Changes
Other Study ID Numbers: C-10-078
Study First Received: January 11, 2011
Results First Received: January 31, 2013
Last Updated: March 8, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Alcon Research:
Dry eye
ocular discomfort

Additional relevant MeSH terms:
Dry Eye Syndromes
Eye Diseases
Keratoconjunctivitis Sicca
Conjunctival Diseases
Conjunctivitis
Corneal Diseases
Keratitis
Keratoconjunctivitis
Lacrimal Apparatus Diseases
Anti-Inflammatory Agents
Difluprednate
Fluprednisolone
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014