Evaluation of Anti-Inflammatory Treatment in Dry Eye Patients

Alcon

Status and phase: Completed; Phase 2

Conditions: Dry Eye Disease

Treatments: Drug: Difluprednate 0.05% ophthalmic emulsion; Other: Difluprednate vehicle

Study type: Interventional

Funder types: Industry

Identifiers

NCT01276223

C-10-078

Details and patient eligibility

About

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.

Full description

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

Enrollment: 722 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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722 participants in 2 patient groups, including a placebo group

Durezol

Experimental group

Description:

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.

Treatment:

Drug: Difluprednate 0.05% ophthalmic emulsion

Vehicle

Placebo Comparator group

Description:

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.

Treatment:

Other: Difluprednate vehicle