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OpenTrials
Completed

NCT Number: NCT01482312

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.

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Key information

Conditions

Myopia Dry Eye Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases Refractive Errors

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cetero Research

Mississauga, Ontario, L4W 1N2, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lotrafilcon A contact lenses

Device

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

Comfilcon A contact lenses

Device

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

Glasses

Other

Glasses per habitual prescription

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

CIBA VISION

Industry

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Nov 30, 2011
Registry last updated
Jul 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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