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

NCT01482312 | Completed Results

• 1 other identifier: P-373-C-900
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Myopia; Dry Eye

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

Lotrafilcon A / Comfilcon A / Glasses

ACTIVE COMPARATOR

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; Device: comfilcon A contact lenses; Other: Glasses

comfilcon A / glasses / lotrafilcon A

ACTIVE COMPARATOR

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; Device: comfilcon A contact lenses; Other: Glasses

glasses / lotrafilcon A / comfilcon A

ACTIVE COMPARATOR

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; Device: comfilcon A contact lenses; Other: Glasses

Interventions

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.

Also known as: Air Optix Night and Day AQUA

Lotrafilcon A / Comfilcon A / Glasses; comfilcon A / glasses / lotrafilcon A; glasses / lotrafilcon A / comfilcon A

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.

Also known as: Biofinity

Lotrafilcon A / Comfilcon A / Glasses; comfilcon A / glasses / lotrafilcon A; glasses / lotrafilcon A / comfilcon A

Glasses OTHER

Glasses per habitual prescription

Lotrafilcon A / Comfilcon A / Glasses; comfilcon A / glasses / lotrafilcon A; glasses / lotrafilcon A / comfilcon A

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CIBA VISION: lead

Study Sites (1)

Cetero Research

Mississauga, Ontario, L4W 1N2, Canada

Location

MeSH Terms

Conditions

Myopia; Dry Eye Syndromes

Interventions

Eyeglasses

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases; Lacrimal Apparatus Diseases

Intervention Hierarchy (Ancestors)

Lenses; Optical Devices; Equipment and Supplies

Results Point of Contact

• Title: Director of Alcon Clinical
• Organization: Alcon Research

1-800-241-7629

Study Officials

• Deepen Patel, MD, CCFP

  Cetero Research, San Antonio

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2011
• First Posted: November 30, 2011
• Study Start: December 1, 2010
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: July 27, 2012
• Results First Posted: July 27, 2012

Record last verified: 2012-06

Locations

CA (1)