NCT02776670

Brief Summary

The purpose of this study is to evaluate the clinical effectiveness of SYSTANE® BALANCE compared to REFRESH OPTIVE® Advanced in subjects with lipid-deficient dry eye.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
308

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2016

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

May 17, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 18, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

July 29, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 22, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 22, 2017

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

June 19, 2019

Completed
Last Updated

June 19, 2019

Status Verified

March 1, 2019

Enrollment Period

1.3 years

First QC Date

May 17, 2016

Results QC Date

November 19, 2018

Last Update Submit

March 19, 2019

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (1)

  • Mean Change From Baseline in Tear Film Break-Up Time (TFBUT) at Day 35

    TFBUT (the time required for dry spots to appear on the surface of the eye after blinking) was assessed with a fluorescein strip and measured in seconds. Using a stopwatch, the investigator measured the time from the last blink until one or more black (dry) spots appeared in the precorneal tear film. The longer it takes, the more stable the tear film. A positive number change from baseline indicates improvement. Only one eye (analysis eye) contributed to the analysis.

    Baseline (Day 0), Day 35

Secondary Outcomes (3)

  • Change From Baseline in TFBUT at Day 35

    Baseline (Day 0), Day 35

  • Lipid Layer Thickness (LLT) Area Under the Curve (AUC120) at Day 35

    Day 35

  • Mean Change From Baseline in Global Ocular Discomfort Visual Analog Scale (VAS) Score at Day 35

    Baseline (Day 0), Day 35

Study Arms (2)

SYSTANE BALANCE

EXPERIMENTAL

Propylene glycol, 0.6% eye drops, 1 drop in each eye 4 times per day for 35 days

Other: Propylene glycol, 0.6% eye drops

REFRESH OPTIVE

ACTIVE COMPARATOR

Lubricant eye drops, 1 drop in each eye 4 times per day for 35 days

Other: Lubricant eye drops

Interventions

Propylene glycol, 0.6% eye dropsOTHER
Also known as: SYSTANE® BALANCE
SYSTANE BALANCE
Lubricant eye dropsOTHER
Also known as: REFRESH OPTIVE® Advanced
REFRESH OPTIVE

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;
  • Must sign an informed consent form;
  • Best-corrected visual acuity (BCVA) of 55 letters or better in each eye as assessed using an early treatment diabetic retinopathy study (ETDRS) chart;
  • Willing to take study products as directed for entire study;

You may not qualify if:

  • Women of childbearing potential who are pregnant, plan to become pregnant during the study, breast feeding, or not using adequate birth control methods;
  • Contact lens use within 30 days prior to Screening Visit, or unwilling to avoid contact lens use during the course of the study;
  • Use of medication excluded by the protocol;
  • Diseases, illnesses, infections, or ocular abnormalities excluded by the protocol;
  • Ocular surgeries or procedures excluded by the protocol;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Propylene GlycolOphthalmic SolutionsLubricant Eye Drops

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Propylene GlycolsGlycolsAlcoholsOrganic ChemicalsPharmaceutical SolutionsSolutionsPharmaceutical PreparationsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesSpecialty Uses of ChemicalsLubricants

Results Point of Contact

Title
Head, CDMA Vision Care
Organization
Alcon, A Novartis Division
alcon.medinfo@alcon.com
1-888-451-3937

Study Officials

  • Clinical Project Manager, PLS

    Alcon, a Novartis Company

    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

May 17, 2016

First Posted

May 18, 2016

Study Start

July 29, 2016

Primary Completion

November 22, 2017

Study Completion

November 22, 2017

Last Updated

June 19, 2019

Results First Posted

June 19, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share