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

Myopia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01482312
• Other study ID #: P-373-C-900
• Status: Completed
• Phase: N/A
• First received: November 28, 2011
• Last updated: June 26, 2012
• Start date: December 2010
• Est. completion date: February 2011

Study information

• Verified date: June 2012
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dry Eye
• Myopia

Intervention

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.
• 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:
• Glasses
Glasses per habitual prescription

Locations

Country	Name	City	State
Canada	Cetero Research	Mississauga	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
CIBA VISION

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No