Overview

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.