Evaluation of Clinical Outcomes After the Use of SYSTANE® HYDRATION

• Status: Completed
• Trial end date: 2016-05-26
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alcon Research
• Treatments: Lubricant Eye Drops; Ophthalmic Solutions; Tetrahydrozoline

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.