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N/A N=99 Randomized Double-blind Treatment

Evaluation of Clinical Outcomes After the Use of SYSTANE® HYDRATION

Dry Eye

Enrolled (actual)
99
Serious AEs
0.9%
Results posted
Jun 2017
Primary outcome: Primary: Change From Baseline in Total Ocular Surface Staining (TOSS) Score at Day 42 — -1.16; -0.92 units on a scale

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
SYSTANE HYDRATION lubricant eye drops (Device); Hyabak 0.15% eye drops (Device); 0.9% saline eye drops (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Alcon Research
Primary completion
May 2016

Outcome Measures

OutcomeResultp-value
PRIMARY
Change From Baseline in Total Ocular Surface Staining (TOSS) Score at Day 42
-1.16; -0.92
SECONDARY
Change From Baseline in IDEEL Treatment Effectiveness Score at Day 42
9.62; 12.80
SECONDARY
Change From Baseline in IDEEL Treatment Inconvenience Score at Day 42
-10.32; 2.24
SECONDARY
Change From Baseline in Tear Film Break-up Time (TFBUT) at Day 42
0.39; 0.68

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.

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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02470429). 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.

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