Comparative Study of Two Marketed 1-day Soft Contact Lenses

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Coopervision, Inc.

ClinicalTrials.gov Identifier:

NCT01464255

First received: October 26, 2011

Last updated: October 12, 2012

Last verified: October 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

October 26, 2011

Last Updated Date

October 12, 2012

Start Date ^ICMJE

August 2011

Primary Completion Date

October 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Objective Lens Fit Measures [ Time Frame: 1 week ] [ Designated as safety issue: No ]

This outcome is an investigator assessment of the lens position and lens movement while lens is on eye.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01464255 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Subjective Subject Assessments of comfort [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Subjective measures of comfort - subject will complete a questionnaire with measures rated on a 0 to 100 point scale This outcome is a score calculated from individual comfort-related questions asked on a 0 -100 scale: 0 = most negative response to 100 = most positive response.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Comparative Study of Two Marketed 1-day Soft Contact Lenses

Official Title ^ICMJE

Clinical Performance of the CooperVision Ocufilcon D 55% 1-day With a Wetting Agent to the CooperVision Ocufilcon B 52% 1-day

Brief Summary

This study is designed to evaluate the CooperVision ocufilcon D 55% 1-Day lens compared to the CooperVision ocufilcon B 52% 1-day contact lens in a 1-week crossover, daily wear regimen.

Detailed Description

This study is designed to evaluate 2 daily wear daily disposable contact lenses that are both currently cleared for the USA market. Study of the CooperVision ocufilcon D 55% 1-Day lens compared to the CooperVision ocufilcon B 52% 1-day contact lens in a 1-week crossover, daily wear regimen. Outcome is calculated from individual responses to subject perception related questions using questionnaire with scores 1 to 100.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Condition ^ICMJE

Myopia

Intervention ^ICMJE

Device: ocufilcon D 1 Day
ocufilcon D 1 Day daily wear soft contact lens
Device: ocufilcon B 1 Day
ocufilcon B 1 Day daily wear soft contact lens

Study Arm (s)

Active Comparator: ocufilcon B /ocufilcon D
ocufilcon B 1Day daily wear soft contact lens worn 1st then cross over and subject wears the ocufilcon D 1Day (55% water) lens 2nd.
Interventions:
- Device: ocufilcon D 1 Day
- Device: ocufilcon B 1 Day
Active Comparator: ocufilcon D / ocufilcon B
ocufilcon D (55% water)1Day daily wear soft contact lens worn 1st then cross over and subject wears the ocufilcon B 1Day lens 2nd.
Interventions:
- Device: ocufilcon D 1 Day
- Device: ocufilcon B 1 Day

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

November 2011

Primary Completion Date

October 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Has had a self reported oculo-visual examination in the last two years.
Is able to wear the study lenses for at least eight hours a day, seven days a week
Aged 18-40 years and has full legal capacity as a volunteer
Has a distance contact lens prescription from -0.25 and -6.00D inclusive
Has spectacle astigmatism of < 1.00D in each eye
Baseline vision of 20/20 best-corrected in each eye.
Is correctable to at least 20/25 distance visual acuity with study contact lenses in each eye
Has read and understood the consent form and willing to sign consent form
Willing and able to follow participant instructions and attend the required study visits Has worn soft contact lenses for at least two weeks prior to the study (daily wear only).

Exclusion Criteria:

Currently wears contact lenses on an extended wear basis.
Not a current or past wearer of the ocufilcon B 52% 1-day lenses.
Has undergone anterior ocular surgery
Is aphakic
Has never worn contact lenses before
Has any systemic disease which clinically contraindicates contact lenses
Has active ocular disease or severe insufficiency of lacrimal secretion (dry eye)
Use of systemic or topical medications that will affect ocular health or visual performance
Slit lamp findings with a grading of greater than 1.0 using the grading scales in Appendix 3
Not possible to achieve a satisfactory fit with the lens design used in the study
Has keratoconus or other corneal irregularity
Participating in another eye-related clinical trial
Pregnant, lactating or planning a pregnancy

Gender

Both

Ages

18 Years to 40 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01464255

Other Study ID Numbers ^ICMJE

CV-OMC-01

Has Data Monitoring Committee

Responsible Party

Coopervision, Inc.

Study Sponsor ^ICMJE

Coopervision, Inc.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Thao N Yeh, OD

U.C. Berkeley, School of Optometry

Information Provided By

Coopervision, Inc.

Verification Date

October 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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