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

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ClinicalTrials.gov Identifier: NCT01482312
Recruitment Status : Completed
First Posted : November 30, 2011
Results First Posted : July 27, 2012
Last Update Posted : July 27, 2012
Sponsor:
Information provided by (Responsible Party):
Alcon Research ( CIBA VISION )

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Myopia Dry Eye Device: lotrafilcon A contact lenses Device: comfilcon A contact lenses Other: Glasses Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : December 2010
Actual Primary Completion Date : February 2011
Actual Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear Tears

Arm Intervention/treatment
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.
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: 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.
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: 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.
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




Primary Outcome Measures :
  1. Tear Osmolarity [ Time Frame: 90 minutes ]
    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.

  2. Ocular Comfort [ Time Frame: 90 minutes ]
    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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01482312


Locations
Canada, Ontario
Cetero Research
Mississauga, Ontario, Canada, L4W 1N2
Sponsors and Collaborators
CIBA VISION
Investigators
Principal Investigator: Deepen Patel, MD, CCFP Cetero Research, San Antonio

Responsible Party: CIBA VISION
ClinicalTrials.gov Identifier: NCT01482312     History of Changes
Other Study ID Numbers: P-373-C-900
First Posted: November 30, 2011    Key Record Dates
Results First Posted: July 27, 2012
Last Update Posted: July 27, 2012
Last Verified: June 2012

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