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Systane Balance - Inflammatory Markers

This study is currently recruiting participants.
Verified May 2013 by Alcon Research
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01733732
First received: November 21, 2012
Last updated: May 9, 2013
Last verified: May 2013
History of Changes
  Purpose

The purpose of this study is to evaluate the ability of Systane Balance dosed four times a day for 30 days to improve comfort over baseline compared to Systane gel.


Condition Intervention
Dry Eye Syndrome
 Other: Systane Balance Eye Drops
Other: Systane Gel Drops

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Study to Evaluate the Efficacy of Systane Balance in Reducing Symptoms and Inflammatory Biomarker Expression of HLA-DR and Tear Film Cytokines in Dry Eye Subjects With Lipid Deficiency

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Mean Change from Baseline in Ocular Surface Disease Index (OSDI) Score at Day 30 [ Time Frame: Baseline (Day 0), Day 30 ] [ Designated as safety issue: No ]
    The OSDI is a 12-question validated questionnaire (resultant overall 0-100 score) used to measure ocular symptoms, visual function, and environmental factors that may affect a patient's vision, where 0 = normal and 100 = severe. The OSDI questionnaire will be administered at both visits and completed by the patient with no assistance from the office staff, physician, or anyone else. The Baseline (Day 0) OSDI score will be subtracted from the Day 30 OSDI score and reported as change. A negative number will represent a perceived improvement in ocular health.


Estimated Enrollment: 50
Study Start Date: March 2013
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Drop A
Systane Balance Eye Drops, one drop in the right eye and one drop in the left eye four times a day for 30 days
 Other: Systane Balance Eye Drops
Other Name: SYSTANE® BALANCE
Active Comparator: Drop B
Systane Gel Drops, one drop in the right eye and one drop in the left eye four times a day for 30 days
 Other: Systane Gel Drops
Other Name: SYSTANE® Gel Drops

  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 the Informed Consent Document;
  • Willing and able to follow instructions and maintain the appointment schedule;
  • 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);
  • Willing to use study drugs 4 times per day in both eyes;
  • Willing to discontinue use of other artificial tear products and other eyedrops;
  • Intraocular pressure less than or equal to 22 mmHg in both eyes;
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • History or evidence of ocular or intraocular surgery or serious 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;
  • Currently using Restasis and 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;
  • Uncontrolled ocular conditions such as uveitis, glaucoma 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 and for at least one week prior to Visit 1;
  • Participation in an investigational drug or device study within 30 days of entering this study;
  • Pregnant or lactating women;
  • Monocular or legally blind;
  • Other protocol-defined exclusion criteria may apply.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01733732

Contacts
Contact: Alcon Call Center 1-888-241-7629

Locations
United States, Texas
Contact Alcon Call Center for Trial Locations Recruiting
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Abayomi Ogundele, PharmD Alcon Research
Principal Investigator: Penny A. Asbell, MD Mount Sinai School of Medicine
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01733732     History of Changes
Other Study ID Numbers: A00976
Study First Received: November 21, 2012
Last Updated: May 9, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Alcon Research:
Dry eye
Lipid deficiency

Additional relevant MeSH terms:
Dry Eye Syndromes
Keratoconjunctivitis Sicca
Lacrimal Apparatus Diseases
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal 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 May 19, 2013