Clinical trial NCT02470429: Evaluation of Clinical Outcomes After the Use of SYSTANE® HYDRATION
Official title: Evaluation of Clinical Outcomes Following the Use of SYSTANE® HYDRATION in Subjects With Dry Eye
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2015-06-12
Enrollment: 114
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 compare SYSTANE® HYDRATION to Hyabak 0.15% based on total ocular surface staining scores (TOSS) at Day 42.

Detailed description: Subjects will first be dispensed preservative-free 0.9% saline eye drops (saline eye drops) to be used during the Run-in phase between Screening Visit and Day 0 (Visit 1). Subjects who qualify will be randomized in a 1:1 manner to receive either treatment with SYSTANE® HYDRATION Lubricant Eye Drops or Hyabak 0.15% Eye Drops.

Eligibility criteria: Inclusion Criteria:

* Willing and able to attend all study visits;
* Use of non-BAK (Benzalkonium Chloride) artificial tears at least once a day, for at least 3 months prior to Screening Visit;
* Diagnosis of Dry Eye (by a health care professional) for at least 3 months prior to Screening Visit;
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Women of childbearing potential who are pregnant or breast feeding;
* Any hypersensitivity to the use of the study products or an allergy to any ingredient(s) contained within study products;
* Ocular abnormalities in either eye that could adversely affect the safety or efficacy outcome;
* Active ocular infection (bacterial, viral, or fungal) or active inflammation not associated with dry eye;
* Use of chronic systemic medications: (prescription, over the counter, vitamins/supplements) on a stable dose for less than 30 days prior to Screening Visit, or any anticipated change in dosing regimen during the course of the study;
* History of ocular or intraocular surgery or serious ocular trauma in either eye within 6 months prior to Screening Visit;
* Any medical condition (systemic or ophthalmic) that may, in the opinion of the Investigator, preclude the safe administration of study products or safe participation in the study;
* Use of any topical ocular over-the-counter or prescribed medications in either eye (with the exception of artificial tears/gels/ lubricants) 2 weeks prior to Screening Visit;
* Contact lens use within 2 weeks prior to Screening Visit and unwilling to avoid contact lens use during the course of the study;
* Unwilling to avoid the use of additional artificial tears (other than the study products) throughout the study;
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Change From Baseline in Total Ocular Surface Staining (TOSS) Score at Day 42
timeFrame: Baseline (Day 0), Day 42
Secondary outcomes:
measure: Change From Baseline in IDEEL Treatment Effectiveness Score at Day 42
timeFrame: Baseline (Day 0), Day 42
measure: Change From Baseline in IDEEL Treatment Inconvenience Score at Day 42
timeFrame: Baseline (Day 0), Day 42
measure: Change From Baseline in Tear Film Break-up Time (TFBUT) at Day 42
timeFrame: Baseline (Day 0), Day 42
Other outcomes:
Locations:
Study officials:
affiliation: Alcon, A Novartis Division
name: Global Trial Leader, Global Development Operations
role: STUDY_DIRECTOR
References: