NCT01688726

Brief Summary

The purpose of this study is to evaluate the repeated use of SYSTANE® BALANCE on stabilizing the tear film of dry eye patients with an unstable tear film.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
91

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2012

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

September 17, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 20, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
1 year until next milestone

Results Posted

Study results publicly available

November 18, 2014

Completed
Last Updated

June 29, 2018

Status Verified

August 1, 2014

Enrollment Period

11 months

First QC Date

September 17, 2012

Results QC Date

November 11, 2014

Last Update Submit

May 31, 2018

Conditions

Dry Eye SyndromeLipid Deficiency

Keywords

Dry eyeOcular surfaceVision complaintTear film stabilityTime controlled functional visual acuityTear film kinetics

Outcome Measures

Primary Outcomes (1)

  • Mean Bulbar Conjunctival Staining

    The conjunctival staining present in the bulbar area was evaluated 120 minutes post eyedrop instillation using a slit lamp with digital image capture and lissamine green strips. Staining coverage as a percentage of the exposed bulbar conjunctiva is reported. A lower percentage in staining area represents a better outcome.

    Month 1

Secondary Outcomes (2)

  • High Contrast logMAR Time Controlled Visual Acuity (TCVA)

    Month 1

  • Non Invasive Tear Film Break-up-time (NIBUT)

    Month 1

Study Arms (2)

SYSTANE BALANCE

EXPERIMENTAL

SYSTANE® BALANCE eyedrops, 1 drop 4 times a day for a continuous period of 1 month

Other: SYSTANE® BALANCE eyedrops

Minims Saline

ACTIVE COMPARATOR

Minims® Saline 0.9% eyedrops, 1 drop 4 times a day for a continuous period of 1 month

Other: Minims® Saline 0.9% eyedrops

Interventions

SYSTANE® BALANCE eyedropsOTHER
SYSTANE BALANCE
Minims® Saline 0.9% eyedropsOTHER
Minims Saline

Eligibility Criteria

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

You may qualify if:

  • Non-contact lens wearer;
  • Symptomatology as defined by the Ocular Surface Disease Index (OSDI) questionnaire;
  • Lipid deficiency;
  • Best visual acuity of 6/9 or better in each eye;
  • Willingness to adhere to the instructions set in the clinical protocol;
  • Signature of the subject informed consent form;

You may not qualify if:

  • Use of systemic medication which might produce dry eye side effects;
  • Systemic disease which might produce dry eye side effects;
  • Active or recent ocular inflammation or infection;
  • Use of ocular medication;
  • Significant ocular anomaly;
  • Previous ocular surgery;
  • Previous use of Restasis;
  • Any medical condition that might be prejudicial to the study;
  • Pregnant or lactating;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Ophthalmic Solutions

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical SolutionsSolutionsPharmaceutical PreparationsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesSpecialty Uses of Chemicals

Results Point of Contact

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

Study Officials

  • Michel Guillon, PhD, FCOptom, FAAO, CCTI

    OTG Research & Consultancy

    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
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2012

First Posted

September 20, 2012

Study Start

December 1, 2012

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

June 29, 2018

Results First Posted

November 18, 2014

Record last verified: 2014-08