Clinical Evaluation of Two Daily Disposable Lenses in Sphere Design

Study Overview
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Brief Summary
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This was a single-blind, interventional, prospective, direct refit, bilateral wear, fixed-sequence crossover study.

Detailed Description
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The aim of this study was to evaluate the visual performance and subjective experiences of daily disposable hydrogel lens (DDH) when compared to daily disposable silicone hydrogel lens (DDSH) after 15 minutes of daily wear each.

Official Title
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Clinical Evaluation of Two Daily Disposable Lenses in Sphere Design

Conditions
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Ametropia

Intervention / Treatment
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* Device: Lens A
* Device: Lens B


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Is at least 18 years of age and has full legal capacity to volunteer. Has read and signed an information consent letter. Self-reports having a full eye examination in the previous two years. Anticipates being able to wear the study lenses for the required time of the study. Is willing and able to follow instructions and maintain the appointment schedule. Has refractive astigmatism no higher than -0.75 DC. Can be fit with the available lens parameters (sphere +8.00 to -10.00D). Can achieve binocular distance vision of at least 20/30 Snellen (logMAR 0.18) with the study contact lenses. Exclusion Criteria: Is participating in any concurrent clinical or research study. Has any known active ocular disease and/or infection that contraindicates contact lens wear. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable. Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable. Has known sensitivity to the diagnostic sodium fluorescein used in the study. Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment. Has undergone refractive error surgery or intraocular surgery.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: All participants received Lens A and then Lens B in fixed-sequence order.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lens A<br>All participants wore Lens A for 15 minutes (Period 1) | Device: Lens A<br>* DDH contact lens for 15 minutes<br>|
| Experimental: Lens B<br>All participants wore Lens B for 15 minutes (Period 2) | Device: Lens B<br>* DDSH contact lens for 15 minutes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lens Fit Acceptance | Measured on a scale of 0-4 (0 = Should not be worn, 1 = Borderline but unacceptable, 2 = Min. acceptable, early review, 3 = Not perfect but OK to dispense, 4 = Perfect) as assessed by an investigator. | 15 minutes |