Clinical Outcomes Following Treatment With Systane® Balance in Dry Eye Subjects

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Alcon Research
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01967147
First received: October 18, 2013
Last updated: July 22, 2014
Last verified: July 2014
  Purpose

The purpose of this study is to demonstrate the superior efficacy of Systane® Balance over Preservative-Free 0.9% Saline following 35 days of QID (4 times a day) dosing in treating dry eye subjects with lipid deficiency.


Condition Intervention
Dry Eye
Drug: Propylene Glycol, 0.6% eye drops
Drug: Preservative-free 0.9% Saline solution

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of Clinical Outcomes Following Treatment With Systane® Balance in Dry Eye Subjects With Lipid Deficiency

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Change from baseline in tear film break-up time (TFBUT) at Day 35 [ Time Frame: Baseline (Day 0), Day 35 ] [ Designated as safety issue: No ]
    TFBUT is defined as the time required for dry spots to appear on the corneal surface after blinking. TFBUT will be assessed by the investigator using ophthalmic dye and a biomicroscope and is measured in seconds. A shorter TFBUT indicates a higher likelihood of dry eye symptoms. Subjects must dose in the office 1 hour ±10 minutes prior to TFBUT assessment. A positive change indicates an improvement in TFBUT.


Secondary Outcome Measures:
  • Change from baseline in Total Ocular Surface Staining (TOSS) score at Day 35 [ Time Frame: Baseline (Day 0), Day 35 ] [ Designated as safety issue: No ]
    The TOSS score is a cumulative cornea and conjunctival staining score. Staining will be assessed by the investigator using ophthalmic dye and a biomicroscope. Three areas of the ocular surface will be graded for dryness on a 0-5 scale (0=Absent, 5=Severe), with a resultant overall score of 0-15. A negative change indicates an improvement in dry eye-related staining.

  • Change from baseline in ocular surface disease index (OSDI) score at Day 35 [ Time Frame: Baseline (Day 0), Day 35 ] [ Designated as safety issue: No ]
    The OSDI is a 12-item quality of life questionnaire designed to assess ocular surface symptoms, their severity, and their impact on the subject's ability to function. Each item will be scored by the subject on a 0-4 Likert-type scale (0=None, 4=All of the Time), with a resultant overall score of 0-100 (0=no disability, 100=complete disability). A negative change number represents a perceived improvement in ocular health.

  • Change from baseline in Impact of Dry Eye on Everyday Life (IDEEL) Treatment Effectiveness score at Day 35 [ Time Frame: Baseline (Day 0), Day 35 ] [ Designated as safety issue: No ]
    The IDEEL is a 10-item questionnaire designed to assess the subject's general satisfaction with treatment use. The subject's responses regarding treatment effectiveness will be graded using a 0-4 Likert-type scale (0=None of the time, 4=All of the time). A Treatment Effectiveness score is calculated, with higher scores indicating greater satisfaction. A positive change number represents perceived improvement.

  • Change from baseline in IDEEL Treatment Inconvenience score at Day 35 [ Time Frame: Baseline (Day 0), Day 35 ] [ Designated as safety issue: No ]
    The IDEEL is a 10-item questionnaire designed to assess the subject's general satisfaction with treatment use. The subject's responses regarding treatment inconvenience will be graded using a 0-4 Likert-type scale (0=All of the time, 4=None of the time). A Treatment Inconvenience score is calculated, with higher scores indicating greater satisfaction. A positive change number represents perceived improvement.


Estimated Enrollment: 294
Study Start Date: February 2014
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Systane® Balance
Propylene Glycol, 0.6% eye drops, 1 drop in each eye, 4 times per day, during Phase I (Day 0-35), followed by 1 drop in each eye as needed during Phase II (Day 35-90).
Drug: Propylene Glycol, 0.6% eye drops
Commercially available eye drops used during Treatment Phase
Other Name: Systane® Balance
Active Comparator: Saline
Preservative-Free 0.9% Saline solution, 1 drop in each eye, 4 times per day, during Phase I (Day 0-35), followed by 1 drop in each eye as needed during Phase II (Day 35-90).
Drug: Preservative-free 0.9% Saline solution
Commercially available solution used as Run-in (1 drop in each eye 4 times a day for 15 days) and during Treatment Phase

Detailed Description:

A 15-day Run-in phase will precede a 90-day Treatment period. The Treatment period will be conducted in 2 phases. In Phase 1, participants will be randomized to either Systane® Balance or Saline and dose 4 times a day for 35 days. In Phase II (Day 35-90) participants will continue to dose with their assigned product on an as-needed basis.

  Eligibility

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

Inclusion Criteria:

  • Must have all of the following in at least 1 eye at Screening:

    1. Meibomian Gland Dysfunction (MGD) grading for Expressibility ≤ 2 and Meibum Quality ≤ 2,
    2. The average of 3 measures of TFBUT < 5 seconds, and
    3. Unanesthetized Schirmer I test of ≥ 3 mm.
  • Must have an Ocular Surface Disease Index (OSDI) Score ≥ 18 at Visit 1 prior to randomization (ie, after 2 weeks of run-in with Preservative-Free 0.9% Saline administered 4 times a day).
  • Must have best-corrected visual acuity of 55 letters or better in each eye as assessed using an early treatment diabetic retinopathy study (ETDRS) chart (letter read method).
  • Physician diagnosis of dry eye at least 6 months prior to Screening visit.
  • Willing and able to attend all study visits.
  • Must sign a written informed consent form.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Subjects on topical ocular treatments containing benzalkonium chloride (BAK), or other products with known toxicity to the corneal surface, within 30 days of Screening.
  • Subjects who have started, stopped, or changed a lid hygiene regimen within 30 days of Screening.
  • Use of any artificial tears/lubricants/gels/rewetting drops within 4 hours of Screening.
  • Women of childbearing potential are excluded from participating in this study if they meet any of the following conditions:

    • Currently pregnant, or
    • Test positive for pregnancy at Screening visit, or
    • Currently breast feeding, or
    • Are not in agreement to use adequate birth control methods to prevent pregnancy throughout the study.
  • Hypersensitivity to the use of any of the study products or allergy to any ingredient in the study products.
  • Has an active ocular allergy.
  • Any ocular abnormalities that could adversely affect the safety or efficacy outcome, including eyelid anomalies, corneal disorders, history of herpes simplex, etc.
  • Subjects taking any systemic medication known to cause dry eye unless they have been on stable therapy/dosage for at least 30 days prior to Screening and will remain on a stable dosage for the duration of the study.
  • History of any ocular or intraocular surgery (including periocular Botox injections), eyelid surgery, keratorefractive procedure, corneal transplant and its variants, or serious ocular trauma within 1 year of Screening.
  • Active ocular infection (bacterial, viral or fungal), active inflammation not associated with dry eye such as uveitis, iritis, active blepharitis, active allergic conjunctivitis, etc.
  • Subjects with punctal plug insertion or diathermy procedure initiated within 30 days of Screening.
  • Any significant illnesses that could be expected to interfere with the study parameters.
  • Subjects with active oculodermal rosacea with meibomian gland dysfunction.
  • Participation in an investigational drug or device trial within 30 days of Screening.
  • Contact lens use within 30 days prior to Screening, or unwilling to avoid contact lens use during the course of the study.
  • Unwilling to avoid the use of additional artificial tears/lubricants/gels/rewetting drops (other than the assigned study medication) throughout the course of the study.
  • Other protocol-defined exclusion criteria may apply.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01967147

Contacts
Contact: Alcon Call Center 1-888-451-3937 alcon.medinfo@alcon.com

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: Christine Rosko, Clinical Manager Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01967147     History of Changes
Other Study ID Numbers: M-13-027
Study First Received: October 18, 2013
Last Updated: July 22, 2014
Health Authority: United Kingdom: Research Ethics Committee
France: Institutional Ethical Committee
France: Haute Autorité de Santé Transparency Commission
Germany: Federal Institute for Drugs and Medical Devices
Germany: Ethics Commission
Spain: Ethics Committee
Netherlands: Independent Ethics Committee
Italy: Ethics Committee
Poland: Ethics Committee

Keywords provided by Alcon Research:
Dry eye
Lipid deficiency
Tear film break-up time

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Pharmaceutical Solutions
Ophthalmic Solutions
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 16, 2014