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

CIBA VISION29 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Myopia Dry Eye

Interventions

lotrafilcon A contact lensesDEVICE

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.

comfilcon A contact lensesDEVICE

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.

GlassesOTHER

Glasses per habitual prescription

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

Cetero Research

Mississauga, Ontario, Canada

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 90 minutes

Data from ClinicalTrials.gov

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