Evaluation of Anti-Inflammatory Treatment in Dry Eye Patients

NCT01276223 | Completed Phase 2 Results

• 1 other identifier: C-10-078
• Study Type: interventional
• Target: 722
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dry Eye Disease

Keywords

Dry eye; ocular discomfort

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Durezol

EXPERIMENTAL

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

Vehicle

PLACEBO COMPARATOR

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

Interventions

Difluprednate 0.05% ophthalmic emulsion DRUG

Topical ocular steroid

Also known as: DUREZOL™

Durezol

Difluprednate vehicle OTHER

Inactive ingredients used as Run-In and placebo comparator

Vehicle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Dry eye patients:
• At least a 6 month history of dry eye.
• Non-contact lens wearer.
• Uses artificial tears.
• Experiences persistent ocular discomfort.

You may not qualify if:

• 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

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (1)

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

Fort Worth, Texas, 76134, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

difluprednate

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Results Point of Contact

• Title: Director of Alcon Clinical
• Organization: Alcon Research

1-888-451-3937

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2011
• First Posted: January 13, 2011
• Study Start: February 1, 2011
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: March 11, 2013
• Results First Posted: March 11, 2013

Record last verified: 2013-03

Locations

US (1)