Multi-Centre Clinical Evaluation Of Two Daily Disposable Contact Lenses

NCT ID: NCT01707238

Last Updated: 2020-08-03

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

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2013-03-31

Brief Summary

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The purpose of this study is to compare the subjective performance for handling of two daily disposable contact lenses, stenfilcon A and etafilcon A.

Detailed Description

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The study is to compare the subjective performance for handling of two daily disposable contact lenses, stenfilcon A and etafilcon A in this cross-over study.

Conditions

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Myopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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stenfilcon A

Participants wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks.

Group Type EXPERIMENTAL

etafilcon A

Intervention Type DEVICE

Participants wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks.

etafilcon A

Participants wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks.

Group Type ACTIVE_COMPARATOR

stenfilcon A

Intervention Type DEVICE

Participants wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks.

Interventions

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etafilcon A

Participants wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks.

Intervention Type DEVICE

stenfilcon A

Participants wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks.

Intervention Type DEVICE

Other Intervention Names

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etafilcon A (Daily Disposable Contact Lens) stenfilcon A (Daily Disposable Contact Lens)

Eligibility Criteria

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Inclusion Criteria

* Be between 16 and 45 years of age (inclusive)
* Adapted soft contact lens (CL) wearers (i.e. \> 1 month)
* Spherical distance CL prescription between -1.00 and -6.00D (inclusive)
* Spectacle cylinder ≤0.75D in the least astigmatic eye, ≤1.00D in the other.
* Correctable to 6/9 (20/30) in both eyes
* Have the use of a mobile phone to send and receive text messages throughout the day for the duration of the study.
* Have read, understood and signed the informed consent
* Willing to comply with the wear schedule (at least 40 hours per week)
* Willing to comply with the study visit schedule

Exclusion Criteria

* Any active corneal infection, injury or inflammation
* Systemic or ocular allergies, which might interfere with CL wear
* Systemic disease, which might interfere with CL wear
* Ocular disease, which might interfere with CL wear
* Strabismus, amblyopia
* Subjects who have undergone corneal refractive surgery and any anterior segment surgery
* Subjects with keratoconus or other severe corneal irregularity contraindicating lens wear
* Pregnant or lactating
* Use of systemic/topical medication contraindicating CL wear
* Use of gas permeable contact lenses within the last month
* Employees of the investigational site or immediate family members of Investigators
* Participation in any concurrent clinical trial or in the last 30 days
Minimum Eligible Age

16 Years

Maximum Eligible Age

45 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

Principal Investigators

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Graeme Young

Role: STUDY_DIRECTOR

Visioncare Research Ltd.

Ruth Craven

Role: STUDY_DIRECTOR

Visioncare Research Ltd.

Locations

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Keith Tempany Opticians

Broadstone, Dorset, United Kingdom

Site Status

Cameron-Davies Optometrists

Southsea, Hampshire, United Kingdom

Site Status

Cameron-Davies Optometrists

Portchester, Hants, United Kingdom

Site Status

Leightons Opticians

St Albans, Hertfordshire, United Kingdom

Site Status

David Gould Opticians

Rawtenstall, Lancashire, United Kingdom

Site Status

Vision Express Optical Lab

Hendon, London, United Kingdom

Site Status

S.H. Harrold

Uxbridge, London, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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EX-MKTG-39

Identifier Type: -

Identifier Source: org_study_id

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