Study to Evaluate the Product Performance of a New Silicone Hydrogel Contact Lens

Bausch + Lomb

Status: Completed

Conditions: Corneal Deformity

Treatments: Device: B&L Investigational Contact Lens

Study type: Interventional

Funder types: Industry

Identifiers

NCT02258139

14-002

Details and patient eligibility

About

This will be a randomized non-dispensing study comparing the overnight corneal swelling of an eye while wearing no contact lens to the Ultra contract lens.

Enrollment: 38 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Be between 18 and 40 years of age (inclusive)
• Not a current contact lens wearer (have not worn extended wear, and not worn in lenses in 6 months)
• Able to read, comprehend and sign an informed consent
• Willing to comply with the wear and study visit schedule
• Monocular best-corrected distance visual acuity >/-20/25 in each eye

Exclusion criteria

• Any active corneal infection, disease, injury, inflammation, past surgery, or ocular abnormality which may interfere with contact lens wear
• Systemic or ocular allergies, which might interfere with contact lens wear
• Systemic disease or condition, which might interfere with contact lens wear
• Use of prescription sleep aids or alcohol within 24 hours of study appointment
• Inability to wear contact lenses
• Under 18 years of age

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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38 participants in 1 patient group

Study Group 1

Experimental group

Description:

1st overnight visit with no contact lens; 2nd overnight visit randomized to either left or right eye for B\&L Investigational Contact Lens

Treatment:

Device: B&L Investigational Contact Lens