N/A
Completed N=97
Clinical Evaluation Following Use of SYSTANE® ULTRA in the Management of Dry Eye
Source: ClinicalTrials.gov NCT02446015 ↗Enrolled (actual)
97
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcomePrimary: Change From Baseline in Total Ocular Surface Staining (TOSS) Score at Day 28 — -1.19; -0.94 units on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Total Ocular Surface Staining (TOSS) Score at Day 28 |
-1.19; -0.94 | — |
| SECONDARY Change From Baseline in Impact of Dry Eye on Everyday Life Symptom-Bother (IDEEL SB) Score at Day 28 |
-7.00; -2.94 | — |
| SECONDARY Change From Baseline in IDEEL Treatment Satisfaction Scores (Treatment Effectiveness and Treatment-related Inconvenience) at Day 28 |
2.43; 0.16; -11.56; -2.77 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT02446015). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.