Subjective Comparison of Pre-Lens Tear Film Stability With Daily Disposable Contact Lenses

Study Overview
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Brief Summary
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The purpose of this study was to compare three CE-marked daily disposable contact lenses for tear film stability as measured by pre-lens non-invasive keratograph break up time (PL NIK-BUT). Secondarily, contact lens surface wettability was assessed.

Detailed Description
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Each participant wore 3 brands of contact lenses in a randomized, cross-over fashion, with a washout phase of at least 1 night between brands.

Official Title
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Subjective Comparison of Pre-Lens Tear Film Stability With Daily Disposable Contact Lenses Using Ring Mire Projection

Conditions
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Myopia, Hyperopia, Refractive Error

Intervention / Treatment
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* Device: Nelfilcon A contact lenses
* Device: Omafilcon A contact lenses
* Device: Etafilcon A contact lenses


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Sign Informed Consent. Adapted soft contact lens wearer. Willing to wear contact lenses up to 12 hours and attend all study visits. Vision correctable to 0.1 (logMAR) or better in each eye at distance with pre-study lenses at Visit 1. Contact lens prescription within the power range specified in the protocol. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Any ocular infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear. Any use of systemic or ocular medications that would contraindicate contact lens wear. Any ocular finding observed during the Visit 1 examination that would contraindicate contact lens wear. Monocular (only 1 eye with functional vision) or fit with only 1 lens. History of herpetic keratitis, ocular surgery, or irregular cornea. Known pregnancy. Unstable tear film with a NIK-BUT value below 13 seconds in either eye without lenses. Participation in any clinical study within 30 days of Visit 1. Other protocol-defined exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 44 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

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DAILIES AquaComfort Plus<br>Nelfilcon A contact lenses worn first, followed by etafilcon A and omafilcon A in randomized order. Each product worn for 1 day, 12 hours. | Device: Nelfilcon A contact lenses<br> <br> * Other names: DAILIES® AquaComfort Plus®;|
| Active Comparator: 1-DAY ACUVUE MOIST<br>Etafilcon A contact lenses worn first, followed by nelfilcon A and omafilcon A in randomized order. Each product worn for 1 day, 12 hours. | Device: Etafilcon A contact lenses<br> <br> * Other names: 1-DAY ACUVUE® MOIST®;|
| Active Comparator: Proclear 1 day<br>Omafilcon A contact lenses worn first, followed by etafilcon A and nelfilcon A in randomized order. Each product worn for 1 day, 12 hours. | Device: Omafilcon A contact lenses<br> <br> * Other names: Proclear® 1 day;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pre-Lens Non-Invasive Keratograph Break Up Time (PL NIK-BUT) at 8 Hours | The pre-lens tear film is the layer of tears located on top of the contact lens (i.e., between the eye lid and the contact lens). The time required for a dry spot to appear on the corneal surface after blinking is referred to as the tear film break-up time. Circular images were projected onto the contact lens using an Oculus Keratograph 5 and the tear film reflection was observed. PL NIK-BUT was recorded at the first sign of distortion. A longer tear film break-up time indicates a more stable tear film. One eye (right eye) contributed to the mean. | Hour 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Wettability Score | The investigator graded lens wettability by corneal region using a scale from 0 (fully wettable) to 3 (clearly visible ring distortions in more than 1/3 of ring reflection zone). The total wettability score per eye was calculated by averaging the grade of each of the 5 corneal regions (central, superior, nasal, inferior, and temporal). One eye (right eye) contributed to the mean. | Hour 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Soft contact lenses, Daily disposable contact lenses, Tear Film Break Up Time, Contact lens wettability