Clinical trial NCT02446015: Clinical Evaluation Following Use of SYSTANE® ULTRA in the Management of Dry Eye
Official title: Clinical Evaluation Following Use of SYSTANE® ULTRA in the Management of Dry Eye
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye Syndrome
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2015-05-15
Enrollment: 159
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: This study consists 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 will 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.

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.

Primary outcomes:
measure: Change From Baseline in Total Ocular Surface Staining (TOSS) Score at Day 28
timeFrame: Baseline (Day 0), Day 28
Secondary outcomes:
measure: Change From Baseline in Impact of Dry Eye on Everyday Life Symptom-Bother (IDEEL SB) Score at Day 28
timeFrame: Baseline (Day 0), Day 28
measure: Change From Baseline in IDEEL Treatment Satisfaction Scores (Treatment Effectiveness and Treatment-related Inconvenience) at Day 28
timeFrame: Baseline (Day 0), Day 28
Other outcomes:
Locations:
Study officials:
affiliation: Alcon Research
name: Sr. Clinical Manager, GCRA
role: STUDY_DIRECTOR
References:
citation: Asbell P, Vingrys AJ, Tan J, Ogundele A, Downie LE, Jerkins G, Shettle L. Clinical Outcomes of Fixed Versus As-Needed Use of Artificial Tears in Dry Eye Disease: A 6-Week, Observer-Masked Phase 4 Clinical Trial. Invest Ophthalmol Vis Sci. 2018 May 1;59(6):2275-2280. doi: 10.1167/iovs.17-23733.