Systane Ultra Versus Maxidex Versus Saline

• Status: Completed
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This study was to evaluate the healing action on the eye surface of the artificial tear Systane® ULTRA as compared to two other eyedrops: Maxidex and Saline solution. Dry eye disease leads to inflammation of the eye surface and treating dry eyes with artificial tears may lead to reduction in this inflammation and improvement of symptoms and signs.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborator: Alcon Research
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Lubricant Eye Drops; Ophthalmic Solutions; Pharmaceutical Solutions; Tetrahydrozoline

Criteria

Inclusion Criteria:

• A score of at least 15 on the Ocular Surface Discomfort Index (OSDI) symptom questionnaire.

• Moderate vital staining, fluorescein (for corneal evaluation, 3-15 on the NEI scale) OR lissamine (for conjunctival evaluation, score of 2-6; temporal and nasal areas, each graded 0-3).

• Willingness to use study drugs 4 times per day in both eyes.

• Willingness to discontinue use of other artificial tear products.

• Patient must provide written informed consent

• Patient must understand the scope of the study including completion of worksheet and be willing to follow instructions and return for all required study visits

• An intraocular pressure less than or equal to 22 mmHg in both eyes

Exclusion Criteria:

• Contact Lens wearers

• Pregnant and/or lactating women

• Those with moderate to severe Meibomian Gland Disease i.e. plugging of 3 or more glands and/or pasty secretion from 3 or more glands or presence of obstructed glands out of a total of 10 glands evaluated in the central portion of the lower lid.

• Uncontrolled systemic or ocular disease

• Dry eye due to seasonal allergic conjunctivitis, contact lens related conjunctivitis or other acute or seasonal diagnosis.

• Are monocular and/or legally blind

• Had ocular surgery or trauma within last six months

• Participation in an ophthalmic drug or device research study within 30 days prior to entry in this study

• Current use of any eye drops other than artificial tears

• Use of Restasis within three months prior to entry in this study