Daily Disposable Comparison Study

NCT ID: NCT02094677

Last Updated: 2020-07-28

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2014-04-30

Brief Summary

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The objective of the study is to compare the overall subjective preference between two Daily Disposable hydrogel lenses when refitted into a third hydrogel lens.

Detailed Description

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This was a two-day, randomized, non-dispensing, double-masked, contralateral study with two parallel groups. Participants were recruited into one of two groups - participants who habitually wore etafilcon A lens and participants who habitually wore nelfilcon A lens.

Conditions

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Myopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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filcon II 3 and etafilcon A

Participants were randomized to a test and control lens for each group in a contralateral design.

Group Type ACTIVE_COMPARATOR

filcon II 3

Intervention Type DEVICE

Participants were randomized to wear filcon II 3 test lens.

etafilcon A

Intervention Type DEVICE

Participants were randomized to wear etafilcon A control lens.

filcon II 3 and nelfilcon A

Participants were randomized to a test and control lens for each group in a contralateral design.

Group Type ACTIVE_COMPARATOR

filcon II 3

Intervention Type DEVICE

Participants were randomized to wear filcon II 3 test lens.

nelfilcon A

Intervention Type DEVICE

Participants were randomized to wear nelfilcon A control lens.

Interventions

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filcon II 3

Participants were randomized to wear filcon II 3 test lens.

Intervention Type DEVICE

etafilcon A

Participants were randomized to wear etafilcon A control lens.

Intervention Type DEVICE

nelfilcon A

Participants were randomized to wear nelfilcon A control lens.

Intervention Type DEVICE

Other Intervention Names

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Hydrogel Daily Disposable Contact Lens Hydrogel Daily Disposable Contact Lens 1 Day Acuvue Moist Hydrogel Daily Disposable Contact Lens Dailies Aqua Comfort Plus

Eligibility Criteria

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Inclusion Criteria

1. Is at least 17 years of age and has full legal capacity to volunteer;
2. Has read and signed an information consent letter;
3. Is willing and able to follow instructions and maintain the appointment schedule;
4. Is correctable to a visual acuity of 20/40 or better (in each eye) with their habitual correction and the assigned study lenses;
5. Habitually wears either 1 Day Acuvue Moist or Dailies Aqua Comfort Plus contact lenses.
6. Demonstrates an acceptable fit with the study lenses

Exclusion Criteria

1. Is participating in any concurrent clinical or research study;
2. Has any known active\* ocular disease and/or infection;
3. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
4. Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
5. Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
6. Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit);
7. Is aphakic;
8. Has undergone refractive error surgery;
Minimum Eligible Age

17 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CooperVision, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Centre for Contact Lens Research

Waterloo, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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EX-MKTG-50

Identifier Type: -

Identifier Source: org_study_id

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