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

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.

Study Overview

• Status: Completed
• Conditions: Dry Eye; Myopia
• Intervention / Treatment: Device: lotrafilcon A contact lenses; Device: comfilcon A contact lenses; Other: Glasses

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Mississauga, Ontario, Canada, L4W 1N2
      • Cetero Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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 Names: 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 Names: 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 Names: 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 Names: 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 Names: 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 Names: Biofinity; Other: Glasses; Glasses per habitual prescription

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tear Osmolarity	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.	90 minutes
Ocular Comfort	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.	90 minutes

Collaborators and Investigators

• Sponsor: CIBA VISION
• Investigators: Principal Investigator: Deepen Patel, MD, CCFP, Cetero Research, San Antonio

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): February 1, 2011
• Study Completion (Actual): February 1, 2011

Study Registration Dates

• First Submitted: November 28, 2011
• First Submitted That Met QC Criteria: November 28, 2011
• First Posted (Estimate): November 30, 2011

Study Record Updates

• Last Update Posted (Estimate): July 27, 2012
• Last Update Submitted That Met QC Criteria: June 26, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Refractive Errors; Dry Eye Syndromes; Myopia
• Other Study ID Numbers: P-373-C-900