Effect of Contact Lenses on Tear Osmolarity in a Controlled Low Humidity Chamber

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier:
NCT01482312
First received: November 28, 2011
Last updated: June 26, 2012
Last verified: June 2012

November 28, 2011
June 26, 2012
December 2010
February 2011   (final data collection date for primary outcome measure)
  • Tear Osmolarity [ Time Frame: 90 minutes ] [ Designated as safety issue: No ]
    The participant spent 90 minutes in the LHE (low humidity environment) chamber, after which tears were sampled from the lower tear meniscus (thin strip of tear fluid at the lower lid margin) and tear osmolarity was measured using a TearLab osmometer, a device that measures the osmolarity of human tears to aid in the diagnosis of dry eye disease. Tear osmolarity is the measure of solid particles (salt) in a solution (tears), and a higher number can be indicative of dry eye disease, while a lower number is generally indicative of the normal tear osmolarity.
  • Ocular Comfort [ Time Frame: 90 minutes ] [ Designated as safety issue: No ]
    Ocular comfort was assessed by the participant after 90 minutes in the LHE and quantified as a linear measure (cm) on a modified Visual Analog Scale (VAS) of 0-20 cm, with a higher number indicating greater perceived comfort.
  • Tear Osmolarity [ Time Frame: After 90 minutes ] [ Designated as safety issue: No ]
    Tears will be sampled from the lower tear meniscus and processed through the TearLab osmometer. Tear osmolarity will be measured after 90 minutes in the Low Humidity Environment (LHE) Chamber.
  • Ocular Comfort [ Time Frame: After 90 minutes ] [ Designated as safety issue: No ]
    Ocular comfort will be recorded by the participant on a diary card using a 5-point scale.
Complete list of historical versions of study NCT01482312 on ClinicalTrials.gov Archive Site
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Effect of Contact Lenses on Tear Osmolarity in a Controlled Low Humidity Chamber
Not Provided

The purpose of this study is to evaluate two different types of contact lenses and their effect on dry eyes when compared to wearing glasses in a controlled, low humidity chamber.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Myopia
  • Dry Eye
  • Device: lotrafilcon A contact lenses
    Commercially marketed, silicone hydrogel, single-vision, soft contact lenses FDA-approved for daily and extended (overnight) wear for up to 30 nights of continuous wear.
    Other Name: Air Optix Night and Day AQUA
  • Device: comfilcon A contact lenses
    Commercially marketed, silicone hydrogel, single-vision, soft contact lenses FDA-approved for daily and extended (overnight) wear for up to 30 nights of continuous wear.
    Other Name: Biofinity
  • Other: Glasses
    Glasses per habitual prescription
  • Active Comparator: Lotrafilcon A / Comfilcon A / Glasses
    Lotrafilcon A contact lenses worn first, followed by comfilcon A contact lenses, followed by habitual glasses. Each product worn for 90 minutes in a controlled, low-humidity environment (LHE) chamber. Each period separated by a washout of approximately 7 days.
    Interventions:
    • Device: lotrafilcon A contact lenses
    • Device: comfilcon A contact lenses
    • Other: Glasses
  • Active Comparator: comfilcon A / glasses / lotrafilcon A
    Comfilcon A contact lenses worn first, followed by glasses, followed by lotrafilcon A contact lenses. Each product worn for 90 minutes in a controlled, low-humidity environment (LHE) chamber. Each period separated by a washout of approximately 7 days.
    Interventions:
    • Device: lotrafilcon A contact lenses
    • Device: comfilcon A contact lenses
    • Other: Glasses
  • Active Comparator: glasses / lotrafilcon A / comfilcon A
    Glasses worn first, followed by lotrafilcon A contact lenses, followed by comfilcon A contact lenses. Each product worn for 90 minutes in a controlled, low-humidity environment (LHE) chamber. Each period separated by a washout of approximately 7 days.
    Interventions:
    • Device: lotrafilcon A contact lenses
    • Device: comfilcon A contact lenses
    • Other: Glasses
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
29
February 2011
February 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age 18 to 70.
  • History of end-of-day or low-humidity dryness with contact lenses.
  • Healthy eyes.
  • Best-corrected visual acuity of 20/50 or better for each eye.
  • Usable pair of eye glasses.
  • Willing and able to attend required study visits.
  • Sign informed consent.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Ocular or systemic allergies or diseases which might interfere with contact lens wear.
  • Clinically significant ocular findings which would contraindicate contact lens wear.
  • Unable to abstain from artificial tears or other ophthalmic drops for at least 7 days.
  • Participation in another clinical study currently or within 30 days of study entry.
  • Spectacle astigmatism of >1.00 diopter.
  • Other protocol-defined exclusion criteria may apply.
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01482312
P-373-C-900
No
Alcon Research ( CIBA VISION )
CIBA VISION
Not Provided
Principal Investigator: Deepen Patel, MD, CCFP Cetero Research, San Antonio
Alcon Research
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP