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

Not Applicable

Completed

• Conditions: Myopia; Dry Eye
• Interventions: Device: lotrafilcon A contact lenses; Device: comfilcon A contact lenses; Other: Glasses

• Registration Number: NCT01482312
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Study First Submitted: 2011-11-28
• Study First Submitted QC: 2011-11-28
• Study First Posted: 2011-11-30
• Results First Submitted: 2012-05-22
• Status Verified: 2012-06
• Results First Submitted QC: 2012-06-26
• Last Update Submitted: 2012-06-26
• Results First Posted: 2012-07-27
• Last Update Posted: 2012-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Lotrafilcon A / Comfilcon A / Glasses	lotrafilcon A contact lenses	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.
Lotrafilcon A / Comfilcon A / Glasses	comfilcon A contact lenses	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.
Lotrafilcon A / Comfilcon A / Glasses	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.
comfilcon A / glasses / lotrafilcon A	lotrafilcon A contact lenses	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.
comfilcon A / glasses / lotrafilcon A	comfilcon A contact lenses	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.
glasses / lotrafilcon A / comfilcon A	lotrafilcon A contact lenses	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.
glasses / lotrafilcon A / comfilcon A	comfilcon A contact lenses	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.
comfilcon A / glasses / lotrafilcon A	Glasses	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.
glasses / lotrafilcon A / comfilcon A	Glasses	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.

Primary Outcome Measures

Name	Time	Method
Tear Osmolarity	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.
Ocular Comfort	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.

Trial Locations

Locations (1)

Cetero Research; 🇨🇦 Mississauga, Ontario, Canada