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

Primary Purpose

Myopia

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Delefilcon A contact lens

Narafilcon A contact lens

Filcon II 3 contact lens

About this trial

This is an interventional treatment trial for Myopia focused on measuring Myopia, Contact Lenses

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Dailies Total 1

TruEye

Clariti

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Pre-Lens Non-Invasive Tear Break-Up Time (PL-NITBUT)

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01548833

First Posted

March 6, 2012

Last Updated

June 6, 2013

Sponsor

Alcon Research

Collaborators

Aston University

1. Study Identification

Unique Protocol Identification Number

NCT01548833

Brief Title

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

Official Title

Randomized Cross-Over Evaluation of Silicone Hydrogel Daily Disposable Soft Contact Lenses

Study Type

Interventional

2. Study Status

Record Verification Date

June 2013

Overall Recruitment Status

Completed

Study Start Date

March 2012 (undefined)

Primary Completion Date

April 2012 (Actual)

Study Completion Date

April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Alcon Research

Collaborators

Aston University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myopia

Keywords

Myopia, Contact Lenses

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

39 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dailies Total 1

Arm Type

Experimental

Arm Description

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.

Arm Title

TruEye

Arm Type

Active Comparator

Arm Description

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.

Arm Title

Clariti

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Device

Intervention Name(s)

Delefilcon A contact lens

Other Intervention Name(s)

DAILIES® TOTAL1™

Intervention Description

Silicone hydrogel contact lens for single use, daily disposable wear.

Intervention Type

Device

Intervention Name(s)

Narafilcon A contact lens

Other Intervention Name(s)

1-DAY ACUVUE® TRUEYE™

Intervention Description

Silicone hydrogel contact lens for single use, daily disposable wear.

Intervention Type

Device

Intervention Name(s)

Filcon II 3 contact lens

Other Intervention Name(s)

Clariti™ 1-day

Intervention Description

Silicone hydrogel contact lens for single use, daily disposable wear

Primary Outcome Measure Information:

Title

Pre-Lens Non-Invasive Tear Break-Up Time (PL-NITBUT)

Description

Time Frame

Day 7, 16 hours after lens insertion

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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. 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jami Kern, PhD

Organizational Affiliation

Alcon Research

Official's Role

Study Director

12. IPD Sharing Statement

Learn more about this trial

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

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