On-Eye Optical Quality of Lotrafilcon B Lenses Over 12 Hours

Indiana University

Status and phase: Completed; Phase 4

Conditions: Myopia; Hyperopia

Treatments: Device: lotrafilcon B with Hydraluxe; Device: Lotrafilcon B

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03881670

Kollbaum002

Details and patient eligibility

About

The current study aims to systematically investigate the diurnal variation in the optical quality of soft contact lenses on eye throughout the day. Subject reported quality of vision will also be evaluated.

Enrollment: 24 patients

Sex: All

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Habitual prescription +5.00 D to -6.00 D
• 18-35 years of age
• The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
• Vertex corrected refractive cylinder must be -0.75 or less.
• Visual acuity best correctable to 20/25 or better for each eye
• The subject must read and sign the Informed Consent form.
• Mesopic pupil size >5.00 mm.

Exclusion criteria

• active condition that would prevent contact lens wear
• history of issues of eye alignment or binocularity by self-report
• doctor diagnosed, self-reported accommodative or binocular vision issues
• doctor diagnosed, self-reported ocular surface disease or dry eye requiring regular, ongoing treatment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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24 participants in 2 patient groups, including a placebo group

Lotrafilcon B

Placebo Comparator group

Treatment:

Device: Lotrafilcon B

Device: lotrafilcon B with Hydraluxe

Lotrafilcon B Hydraluxe

Active Comparator group

Treatment:

Device: Lotrafilcon B

Device: lotrafilcon B with Hydraluxe