Evaluation of Clinical Outcomes After the Use of SYSTANE® HYDRATION

NCT ID: NCT02470429

Last Updated: 2018-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 114 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-17
• Study Completion Date: 2016-05-26

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.

Conditions

Dry Eye

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

SYSTANE HYDRATION

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

Group Type: EXPERIMENTAL

SYSTANE HYDRATION lubricant eye drops

Intervention Type: DEVICE

Preserved with POLYQUAD (polidronium chloride) 0.001%

0.9% saline eye drops

Intervention Type: DRUG

Preservative-free, one drop 4 times a day in each eye (run-in period)

Hyabak 0.15%

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

Group Type: ACTIVE_COMPARATOR

Hyabak 0.15% eye drops

Intervention Type: DEVICE

Preservative-free

0.9% saline eye drops

Intervention Type: DRUG

Preservative-free, one drop 4 times a day in each eye (run-in period)

Interventions

SYSTANE HYDRATION lubricant eye drops

Preserved with POLYQUAD (polidronium chloride) 0.001%

Intervention Type: DEVICE

Hyabak 0.15% eye drops

Preservative-free

Intervention Type: DEVICE

0.9% saline eye drops

Preservative-free, one drop 4 times a day in each eye (run-in period)

Intervention Type: DRUG

Other Intervention Names

SYSTANE® HYDRATION; Hyabak 0.15%

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;

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;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Global Trial Leader, Global Development Operations

Role: STUDY_DIRECTOR

Alcon, A Novartis Division

Other Identifiers

EXK947-P001

Identifier Type: -

Identifier Source: org_study_id