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

October 26, 2011
October 12, 2012
August 2011
October 2011   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01464255 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Comparative Study of Two Marketed 1-day Soft Contact Lenses
Clinical Performance of the CooperVision Ocufilcon D 55% 1-day With a Wetting Agent to the CooperVision Ocufilcon B 52% 1-day

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Myopia
  • 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 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
November 2011
October 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 40 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01464255
CV-OMC-01
No
Coopervision, Inc.
Coopervision, Inc.
Not Provided
Principal Investigator: Thao N Yeh, OD U.C. Berkeley, School of Optometry
Coopervision, Inc.
October 2012

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