Clinical Evaluation Following Use of SYSTANE® ULTRA in the Management of Dry Eye
| Status: | Completed |
|---|---|
| Conditions: | Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 7/28/2016 |
| Start Date: | June 2015 |
| End Date: | June 2016 |
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. This study will be
conducted in the US and in Australia.
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. This study will be
conducted in the US and in Australia.
This study will consist of a 14-day Run-in Phase (between the Screening Visit and
Baseline/Visit 1) and a Treatment Phase. During the Run-in Phase, subjects will discontinue
current artificial tears and be dispensed SYSTANE® ULTRA to be administered 1 drop in each
eye as needed (PRN). Subjects who meet the re-evaluation criteria after the Run-in Phase
will be randomized in a 1:2 manner to receive treatment with SYSTANE® ULTRA 4 times per day
(QID) or PRN, respectively, for 28 days.
Baseline/Visit 1) and a Treatment Phase. During the Run-in Phase, subjects will discontinue
current artificial tears and be dispensed SYSTANE® ULTRA to be administered 1 drop in each
eye as needed (PRN). Subjects who meet the re-evaluation criteria after the Run-in Phase
will be randomized in a 1:2 manner to receive treatment with SYSTANE® ULTRA 4 times per day
(QID) or PRN, respectively, for 28 days.
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,
within 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.
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