The Effect of Systane Balance on Tear Film Break Up Time in Dry Eye Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01718028
First received: October 29, 2012
Last updated: February 22, 2013
Last verified: February 2013
  Purpose

The purpose of this study is to evaluate the ability of Systane Balance dosed four times a day for 30 days to increase non-invasive tear film break up time over baseline compared to a saline control in dry eye subjects with lipid deficiency.


Condition Intervention
Dry Eye
Other: Systane BALANCE eye drops
Other: Saline eye drops

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Systane Balance on Non-Invasive Tear Film Break Up Time (NITFBUT) in Dry Eye Subjects With Lipid Deficiency Following 30 Days of Use

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Mean Change from Baseline in Non-Invasive Tear Film Break Up Time (NITFBUT) at 30 Days [ Time Frame: Baseline (Day 0), Day 30 ] [ Designated as safety issue: No ]
    The subject will be instructed to blink naturally. After 10 seconds, the subject will stare straight ahead without blinking until told otherwise. The precorneal tear film will be viewed noninvasively using a Tearscope device, and the investigator will time the occurrence of the first break in the tear film, i.e., appearance of a dry area.


Enrollment: 51
Study Start Date: September 2012
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Systane BALANCE
Systane BALANCE eye drops, one drop in each eye 4 times a day for 30 days
Other: Systane BALANCE eye drops
Systane BALANCE ocular emulsion, one drop in each eye 4 times daily for 30 days
Other Name: SYSTANE® BALANCE
Active Comparator: Saline
Saline eye drops, one drop in each eye 4 times a day for 30 days
Other: Saline eye drops
Sodium chloride 0.9% saline solution, one drop in each eye 4 times daily for 30 days

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Read, sign, and date an information consent letter;
  • Willing and able to follow instructions and maintain the appointment schedule;
  • Best-corrected visual acuity of 0.6 logMAR or better in each eye as assessed at Visit 1;
  • Must not have used any topical ocular drops for approximately 24 hours prior to Visit 1;
  • Meet protocol-specified criteria for dry eye at Visit 1;
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • History or evidence of ocular or intraocular surgery or serious ocular trauma in either eye within the past six months;
  • Current punctal occlusion of any type (e.g., collagen plugs, silicone plugs);
  • History of intolerance or hypersensitivity to any component of the study medications;
  • 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;
  • 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;
  • Ocular conditions such as conjunctival infections, iritis, or any other ocular condition that may preclude the safe administration of either drop under investigation;
  • Unwilling to discontinue contact lens wear during the study period. Contact lens wear must have been discontinued at least one week prior to Visit 1.
  • Participation in an investigational drug or device study within 30 days of entering this study;
  • Other protocol-defined exclusion criteria may apply.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01718028

Locations
Argentina
Consultório Oftalmológico
Martinez, Buenos Aires, Argentina
Sponsors and Collaborators
Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01718028     History of Changes
Other Study ID Numbers: RDG-11-262
Study First Received: October 29, 2012
Last Updated: February 22, 2013
Health Authority: Argentina: CCIS - Comisión Conjunta de Investigación en Salud - Ministerio de Salud- La Provincia Buenos Aires
Argentina: Human Research Bioethics Committee

Keywords provided by Alcon Research:
Systane BALANCE
Dry eye
lipid deficiency
NITFBUT

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Tetrahydrozoline
Nasal Decongestants
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Respiratory System Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 18, 2013