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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
  Purpose

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 Intervention
Myopia
Dry Eye
Device: lotrafilcon A contact lenses
Device: comfilcon A contact lenses
Other: Glasses

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • 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.


Enrollment: 29
Study Start Date: December 2010
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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.
  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: 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
  More Information

No publications provided

Responsible Party: Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier: NCT01482312     History of Changes
Other Study ID Numbers: P-373-C-900
Study First Received: November 28, 2011
Results First Received: May 22, 2012
Last Updated: June 26, 2012
Health Authority: Canada: Ethics Review Committee

ClinicalTrials.gov processed this record on November 27, 2014