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
  Purpose

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.


Condition Intervention
Myopia
Device: ocufilcon D 1 Day
Device: ocufilcon B 1 Day

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Clinical Performance of the CooperVision Ocufilcon D 55% 1-day With a Wetting Agent to the CooperVision Ocufilcon B 52% 1-day

Resource links provided by NLM:


Further study details as provided by Coopervision, Inc.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 50
Study Start Date: August 2011
Study Completion Date: November 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
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.
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01464255

Locations
United States, California
Clinical Research Center, U.C. Berkeley, School of Optometry
Berkeley, California, United States, 94720-
Sponsors and Collaborators
Coopervision, Inc.
Investigators
Principal Investigator: Thao N Yeh, OD U.C. Berkeley, School of Optometry
  More Information

No publications provided

Responsible Party: Coopervision, Inc.
ClinicalTrials.gov Identifier: NCT01464255     History of Changes
Other Study ID Numbers: CV-OMC-01
Study First Received: October 26, 2011
Last Updated: October 12, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Coopervision, Inc.:
contact lenses

Additional relevant MeSH terms:
Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on July 20, 2014