Pre-Lens Tear Film Performance of Silicone Hydrogel Daily Disposable Contact Lenses

Not Applicable

Completed

• Conditions: Myopia
• Interventions: Device: Delefilcon A contact lens; Device: Narafilcon A contact lens; Device: Filcon II 3 contact lens

• Registration Number: NCT01548833
• Lead Sponsor: Alcon Research

Brief Summary

The purpose of this study was to compare the pre-lens tear film stability of DAILIES TOTAL1® silicone hydrogel daily disposable contact lenses with that of two other silicone hydrogel daily disposable contact lenses.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-03-06
• Study First Submitted QC: 2012-03-07
• Study First Posted: 2012-03-08
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Results First Submitted: 2013-04-22
• Status Verified: 2013-06
• Results First Submitted QC: 2013-06-06
• Last Update Submitted: 2013-06-06
• Results First Posted: 2013-06-24
• Last Update Posted: 2013-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

• Be of legal age of consent and sign written Informed Consent document, or if under legal age, have written consent of parent or guardian to participate.
• Require vision correction in both eyes.
• Wear either daily disposable contact lenses or weekly/monthly replacement contact lenses in powers between -0.50 and -10.00 diopters, cylinder ≤0.75 diopter, no ADD correction.
• Wear habitual contact lenses an average of 12-14 hours per day, at least 5 days per week.
• Willing and able to wear study contact lenses 16 hours per day.
• Able to achieve visual acuity of at least 6/7.5 in each eye with study lenses.
• Other protocol-defined inclusion criteria may apply.

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Exclusion Criteria

• Currently wearing DAILIES TOTAL1®, 1-DAY ACUVUE® TRUEYE™, or Clariti™ 1day contact lenses.
• Require monovision correction.
• Any systemic or ocular disease or disorder (refractive disorder allowed and dry eye permitted), complicating factors, or structural abnormality that would negatively affect the conduct or outcome of the study.
• Ocular surgery/trauma within the last 6 months.
• Topical or systemic antibiotic use within 7 days of enrollment.
• Topical ocular or systemic corticosteroid use within 14 days of enrollment.
• Pregnant and nursing women.
• Participation in any other ophthalmic drug or device clinical trial within 30 days of enrollment.
• 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 Total 1	Delefilcon A contact lens	Delefilcon A, followed by narafilcon A and filcon II 3 in randomized order. Each product worn for 1 week in a daily wear, daily disposable manner.
Dailies Total 1	Narafilcon A contact lens	Delefilcon A, followed by narafilcon A and filcon II 3 in randomized order. Each product worn for 1 week in a daily wear, daily disposable manner.
Dailies Total 1	Filcon II 3 contact lens	Delefilcon A, followed by narafilcon A and filcon II 3 in randomized order. Each product worn for 1 week in a daily wear, daily disposable manner.
TruEye	Delefilcon A contact lens	Narafilcon A, followed by delefilcon A and filcon II 3 in randomized order. Each product worn for 1 week in a daily wear, daily disposable manner.
TruEye	Narafilcon A contact lens	Narafilcon A, followed by delefilcon A and filcon II 3 in randomized order. Each product worn for 1 week in a daily wear, daily disposable manner.
TruEye	Filcon II 3 contact lens	Narafilcon A, followed by delefilcon A and filcon II 3 in randomized order. Each product worn for 1 week in a daily wear, daily disposable manner.
Clariti	Delefilcon A contact lens	Filcon II 3, followed by narafilcon A and delefilcon A in randomized order. Each product worn for 1 week in a daily wear, daily disposable manner.
Clariti	Narafilcon A contact lens	Filcon II 3, followed by narafilcon A and delefilcon A in randomized order. Each product worn for 1 week in a daily wear, daily disposable manner.
Clariti	Filcon II 3 contact lens	Filcon II 3, followed by narafilcon A and delefilcon A in randomized order. Each product worn for 1 week in a daily wear, daily disposable manner.

Primary Outcome Measures

Name	Time	Method
Pre-Lens Non-Invasive Tear Break-Up Time (PL-NITBUT)	Day 7, 16 hours after lens insertion	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 corneal surface using a CA-1000 topographer, and the tear film reflection was observed on a 30-inch flat panel monitor. PL-NITBUT was recorded at the first sign of image distortion. Three measurements were taken and averaged together. A higher number represents a longer tear film break up time.