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

Ciba Vision

Status: Completed

Conditions: Myopia; Dry Eye

Treatments: Other: Glasses; Device: lotrafilcon A contact lenses; Device: comfilcon A contact lenses

Study type: Interventional

Funder types: Industry

Identifiers

NCT01482312

P-373-C-900

Details and patient eligibility

About

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.

Enrollment: 29 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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29 participants in 3 patient groups

Lotrafilcon A / Comfilcon A / Glasses

Active Comparator group

Description:

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.

Treatment:

Device: comfilcon A contact lenses

Device: lotrafilcon A contact lenses

Other: Glasses

comfilcon A / glasses / lotrafilcon A

Active Comparator group

Description:

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.

Treatment:

Device: comfilcon A contact lenses

Device: lotrafilcon A contact lenses

Other: Glasses

glasses / lotrafilcon A / comfilcon A

Active Comparator group

Description:

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.

Treatment:

Device: comfilcon A contact lenses

Device: lotrafilcon A contact lenses

Other: Glasses