NCT01733732

Brief Summary

The purpose of this study is to evaluate the ability of SYSTANE® BALANCE and SYSTANE® Gel to improve comfort in subjects with dry eyes.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2013

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

November 21, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 27, 2012

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

November 4, 2014

Completed
Last Updated

June 29, 2018

Status Verified

November 1, 2013

Enrollment Period

7 months

First QC Date

November 21, 2012

Results QC Date

October 29, 2014

Last Update Submit

May 31, 2018

Conditions

Dry Eye Syndrome

Keywords

Dry eyeLipid deficiencyInflammatory markers

Outcome Measures

Primary Outcomes (1)

  • Ocular Comfort Measured as Mean Change From Baseline in OSDI Score by Visit

    The Ocular Surface Disease Index (OSDI) is a 12-question validated questionnaire used to measure ocular symptoms, visual function, and environmental factors that may affect a patient's vision. The OSDI scoring scale ranges from 0 to 100. The lower the score, the more symptomatic relief from dry eye symptoms a patient experiences. Baseline-adjusted scores were tabulated; a negative number change from baseline indicates a perceived improvement in ocular comfort.

    Baseline (Day 0), Day 14, Day 30

Secondary Outcomes (11)

  • Mean Change From Baseline in Best-corrected Visual Acuity (BCVA) by Visit

    Baseline (Day 0), Day 14, Day 30

  • Percentage of Eyes With Normal Slit-lamp Assessment

    Baseline (Day 0), Day 14, Day 30

  • Meibomian Gland Expression

    Baseline (Day 0), Day 14, Day 30

  • Mean Change From Baseline in Non-invasive Keratographic Tear Break up Time (NIKBUT) by Visit

    Baseline (Day 0), Day 14, Day 30

  • Mean Change From Baseline in Tear Meniscus Height (TMH) by Visit

    Baseline (Day 0), Day 14, Day 30

  • +6 more secondary outcomes

Study Arms (2)

Systane Balance

EXPERIMENTAL

SYSTANE® BALANCE Lubricant Eye Drops, 1 drop in each eye 4 times a day for 30 days

Other: SYSTANE® BALANCE Lubricant Eye Drops

Systane Gel

ACTIVE COMPARATOR

SYSTANE® Gel, 1 drop in each eye 4 times a day for 30 days

Other: SYSTANE® Gel

Interventions

SYSTANE® BALANCE Lubricant Eye DropsOTHER
Also known as: SYSTANE® BALANCE
Systane Balance
SYSTANE® GelOTHER
Systane Gel

Eligibility Criteria

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

You may qualify if:

  • Read, sign, and date the Informed Consent Document;
  • Must not have used any topical ocular drops for approximately 24 hours prior to Visit 1;
  • Meet the protocol-specified dry eye criteria at Screening Visit (Visit 1);
  • Intraocular pressure (IOP) less than or equal to 22 millimeters of mercury (mmHg) in both eyes;

You may not qualify if:

  • History or evidence of ocular or intraocular surgery or serious trauma in either eye within the past 6 months;
  • Current punctal occlusion of any type (e.g., collagen plugs, silicone plugs);
  • History or evidence of epithelial herpes simplex keratitis (dendritic keratitis); vaccinia; active or recent varicella viral disease of the cornea and/or conjunctiva; chronic bacterial disease of the cornea and/or conjunctiva and/or eyelids; mycobacterial infection of the eye; and/or fungal disease of the eye;
  • Use of any concomitant topical ocular medications during the study period;
  • Currently using Restasis but unwilling to discontinue its use 1 month prior to screening and for the entire study period;
  • Use of systemic medications that may contribute to dry eye unless on a stable dosing regimen for a minimum of 30 days prior to Visit 1 and that remains stable throughout the study;
  • Uncontrolled ocular conditions such as uveitis, glaucoma or any other ocular condition that may preclude the safe administration of either drop under investigation;

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
Abayomi Ogundele, Pharm.D, Global Brand Medical Affairs Lead
Organization
Alcon Research, Ltd.
alcon.medinfo@alcon.com
1-888-451-3937

Study Officials

  • Abayomi Ogundele, PharmD

    Alcon Research

    STUDY DIRECTOR

  • Penny A. Asbell, MD

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

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

November 21, 2012

First Posted

November 27, 2012

Study Start

March 1, 2013

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

June 29, 2018

Results First Posted

November 4, 2014

Record last verified: 2013-11