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

Study Overview
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Brief Summary
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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.

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

Conditions
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Hyperopia, Myopia

Intervention / Treatment
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* Device: Lotrafilcon B
* Device: lotrafilcon B with Hydraluxe


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Lotrafilcon B<br> | Device: Lotrafilcon B<br>* commercially available contact lens<br>Device: lotrafilcon B with Hydraluxe<br>* commercially available contact lens<br>|
| Active Comparator: Lotrafilcon B Hydraluxe<br> | Device: Lotrafilcon B<br>* commercially available contact lens<br>Device: lotrafilcon B with Hydraluxe<br>* commercially available contact lens<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Higher Order Aberrations | Higher-order Root Mean Squared (RMS) over a 3mm pupil; difference in RMS error between 0 and 12 hour timepoints; averaged across all subjects | 0-12 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective Stability of Vision Rating | Subjects are asked to rate their stability of vision on a numeric rating scale (0, poor to 100 excellent) (Kollbaum 2012). The difference between time 0 and time 12 hours is reported for all subjects (negative number represents a decrease in stability of vision) | 0-12 hours | 
| Image Quality Metrics | Root Mean Squared (RMS) wavefront error over a 3mm pupil; difference in RMS error between 0 and 12 hour timepoints; averaged across all subjects | 0-12 hours |