Clinical Evaluation Following Use of SYSTANE® ULTRA in the Management of Dry Eye

• Status: Completed
• Trial end date: 2016-06-21
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the clinical benefits of SYSTANE® ULTRA Lubricant Eye Drops using total ocular surface staining scores in subjects with dry eye administering it either as a scheduled regimen or as-needed after 28 days of treatment.

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

Details

• Lead Sponsor: Alcon Research
• Treatments: Lubricant Eye Drops; Ophthalmic Solutions; Tetrahydrozoline

Criteria

Inclusion Criteria:

• Willing and able to attend all study visits.

• Use of BAK-free artificial tear drops on an as needed basis, at least once a week, for at least 3 months prior to Screening Visit (maximum use of 4 drops a day).

• At least one '8 hour waking period' per week during the run-in phase without using the provided artificial tear.

• Use provided artificial tear at least once a week during run-in phase.

• Willing to take study treatment as directed for the entire study and able to complete the study diaries as required.

• Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

• Use of artificial tears, as specified in the protocol.

• Use of topical ocular medications, as specified in the protocol.

• Women of childbearing potential who are pregnant, breast feeding, plan to become pregnant during the study, or not using adequate birth control methods to prevent pregnancy throughout the study.

• Any hypersensitivity to the use of the study product formulations or an allergy to any ingredient(s) contained within product formulations.

• Ocular abnormalities, infection, or active inflammation (not associated with dry eye) as specified in the protocol.

• Ocular or intraocular surgery or serious ocular trauma in either eye within the past 6 months prior to Screening Visit.

• Any medical condition (systemic or ophthalmic) that may preclude the safe administration of test article or safe participation in the study.

• Contact lens use within 2 weeks prior to Screening Visit, and unwilling to avoid contact lens use during the course of the study.

• Other protocol-specified exclusion criteria may apply.