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

Not Applicable

Completed

• Conditions: Myopia; Hyperopia; Refractive Error
• Interventions: Device: Nelfilcon A contact lenses; Device: Etafilcon A contact lenses; Device: Omafilcon A contact lenses

• Registration Number: NCT01839318
• Lead Sponsor: Alcon Research

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-04-22
• Study First Submitted QC: 2013-04-22
• Study First Posted: 2013-04-24
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2014-05
• Results First Submitted: 2014-05-21
• Results First Submitted QC: 2014-05-21
• Last Update Submitted: 2014-05-21
• Results First Posted: 2014-06-20
• Last Update Posted: 2014-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
DAILIES AquaComfort Plus	Nelfilcon A contact lenses	Nelfilcon A contact lenses worn first, followed by etafilcon A and omafilcon A in randomized order. Each product worn for 1 day, 12 hours.
1-DAY ACUVUE MOIST	Etafilcon A contact lenses	Etafilcon A contact lenses worn first, followed by nelfilcon A and omafilcon A in randomized order. Each product worn for 1 day, 12 hours.
Proclear 1 day	Omafilcon A contact lenses	Omafilcon A contact lenses worn first, followed by etafilcon A and nelfilcon A in randomized order. Each product worn for 1 day, 12 hours.

Primary Outcome Measures

Name	Time	Method
Pre-Lens Non-Invasive Keratograph Break Up Time (PL NIK-BUT) at 8 Hours	Hour 8	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.

Secondary Outcome Measures

Name	Time	Method
Total Wettability Score	Hour 8	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.