NCT02470429

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
114

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2015

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 10, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 12, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

July 17, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 26, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 26, 2016

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

June 16, 2017

Completed
Last Updated

July 2, 2018

Status Verified

June 1, 2017

Enrollment Period

10 months

First QC Date

June 10, 2015

Results QC Date

April 4, 2017

Last Update Submit

May 31, 2018

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in Total Ocular Surface Staining (TOSS) Score at Day 42

    The TOSS score is a cumulative cornea and conjunctival staining score. After instilling ophthalmic dye in the eye, the investigator graded 3 areas of the ocular surface for dryness on a scale from 0 to 5, where 0=Absent and 5=Severe. The 3 scores were summed for a resultant overall 0-15 score. A more negative change value indicates greater efficacy. One eye (study eye) contributed to the analysis.

    Baseline (Day 0), Day 42

Secondary Outcomes (3)

  • Change From Baseline in IDEEL Treatment Effectiveness Score at Day 42

    Baseline (Day 0), Day 42

  • Change From Baseline in IDEEL Treatment Inconvenience Score at Day 42

    Baseline (Day 0), Day 42

  • Change From Baseline in Tear Film Break-up Time (TFBUT) at Day 42

    Baseline (Day 0), Day 42

Study Arms (2)

SYSTANE HYDRATION

EXPERIMENTAL

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

Device: SYSTANE HYDRATION lubricant eye dropsDrug: 0.9% saline eye drops

Hyabak 0.15%

ACTIVE COMPARATOR

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

Device: Hyabak 0.15% eye dropsDrug: 0.9% saline eye drops

Interventions

SYSTANE HYDRATION lubricant eye dropsDEVICE

Preserved with POLYQUAD (polidronium chloride) 0.001%

Also known as: SYSTANE® HYDRATION
SYSTANE HYDRATION
Hyabak 0.15% eye dropsDEVICE

Preservative-free

Also known as: Hyabak 0.15%
Hyabak 0.15%
0.9% saline eye dropsDRUG

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

Hyabak 0.15%SYSTANE HYDRATION

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Results Point of Contact

Title
WW Medical Affairs Director, GMA Ophthalmics
Organization
Alcon, A Novartis Division
alcon.medinfo@alcon.com
1-888-451-3937

Study Officials

  • Global Trial Leader, Global Development Operations

    Alcon, A Novartis Division

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2015

First Posted

June 12, 2015

Study Start

July 17, 2015

Primary Completion

May 26, 2016

Study Completion

May 26, 2016

Last Updated

July 2, 2018

Results First Posted

June 16, 2017

Record last verified: 2017-06