Evaluation of Clinical Outcomes After the Use of SYSTANE® HYDRATION

Alcon

Status: Completed

Conditions: Dry Eye

Treatments: Drug: 0.9% saline eye drops; Device: Hyabak 0.15% eye drops; Device: SYSTANE HYDRATION lubricant eye drops

Study type: Interventional

Funder types: Industry

Identifiers

NCT02470429

EXK947-P001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 114 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

114 participants in 2 patient groups

SYSTANE HYDRATION

Experimental group

Description:

SYSTANE HYDRATION lubricant eye drops, 1 drop 4 times per day (QID) in each eye for 42 days

Treatment:

Drug: 0.9% saline eye drops

Device: SYSTANE HYDRATION lubricant eye drops

Hyabak 0.15%

Active Comparator group

Description:

Hyabak 0.15% eye drops, 1 drop 4 times per day (QID) in each eye for 42 days

Treatment:

Drug: 0.9% saline eye drops

Device: Hyabak 0.15% eye drops