Clinical Evaluation of Two Daily Disposable Contact Lenses

This study has been completed.
Sponsor:
Collaborators:
Singapore Polytechnic University
Visioncare Research Ltd.
Information provided by (Responsible Party):
Vistakon
ClinicalTrials.gov Identifier:
NCT01163760
First received: September 29, 2008
Last updated: March 14, 2014
Last verified: March 2014

September 29, 2008
March 14, 2014
September 2007
September 2007   (final data collection date for primary outcome measure)
Lens Comfort [ Time Frame: 1-week follow-up ] [ Designated as safety issue: No ]
Lens comfort was evaluated via the subjective question: "How comfortable did your eyes feel at the end of the day when wearing the contact lenses you were provided?" (excellent/very good=5...very good=3...Poor=0)
Lens Comfort [ Time Frame: 1 week ] [ Designated as safety issue: No ]
Lens comfort was calculated as a weighted combined score from individual comfort-related questions asked on a 1-5 scale. 1 is the most negative and 5 is the most positive. >0 = comfortable, <0 = uncomfortable
Complete list of historical versions of study NCT01163760 on ClinicalTrials.gov Archive Site
Comfort Throughout the Whole Day [ Time Frame: 1-week follow-up ] [ Designated as safety issue: No ]
Comfort throughout the day was evaluated via subjective question: "Comfort throughout the whole day" and is reported as an aggregate of "Agree Strongly and Agree Somewhat".
Not Provided
Comfort While Working on Computer [ Time Frame: 1-week-follow-up ] [ Designated as safety issue: No ]
Comfort throughout the day was evaluated via subjective question: "Comfort while working on computer" and is reported as an aggregate of "Agree Strongly and Agree Somewhat".
Not Provided
 
Clinical Evaluation of Two Daily Disposable Contact Lenses
Not Provided

This study seeks to evaluate the clinical performance of two daily disposable contact lenses.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Refractive Error
  • Device: etafilcon A
    daily disposable contact lens
  • Device: ocufilcon D
    daily disposable contact lens
  • etafilcon A / ocufilcon D
    etafilcon A contact lens worn first daily disposable , ocufilcon D contact lens worn second daily disposable
    Interventions:
    • Device: etafilcon A
    • Device: ocufilcon D
  • oculfilcon D / etafilcon A
    ocufilcon D contact lens worn first, etafilcon A contact lens worn second
    Interventions:
    • Device: etafilcon A
    • Device: ocufilcon D
  • ocufilcon D / ocufilcon D
    ocufilcon D contact lens worn first and second
    Intervention: Device: ocufilcon D
  • etafilcon A / etafilcon A
    etafilcon A contact lens worn first and second
    Intervention: Device: etafilcon A
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
September 2007
September 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Be between 21 and 39 years of age.
  • Signed Written Informed Consent and Investigator to record this on Case Report Form (CRF) in appropriate space.
  • Be existing (i.e. successfully worn for 1-month prior to the study) soft contact lens wearers (no extended wear in the last 3 months, but silicone hydrogels in daily wear are allowed).
  • Require a visual correction in both eyes (monovision allowed but no monofit).
  • Have a contact lens spherical distance requirement between -1.00D and -6.00D in both eyes.
  • Astigmatism of 1.00D or less in both eyes.
  • Be able to wear the lens powers available for this study.
  • Be correctable to a visual acuity of 20/30 or better in each eye.
  • Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having:

    • No amblyopia.
    • No evidence of lid abnormality or infection.
    • No conjunctival abnormality or infection.
    • No clinically significant slit lamp findings (i.e. edema, staining, scarring, vascularisation, infiltrates or abnormal opacities).
    • No other active ocular disease.

Exclusion Criteria:

  • Requires concurrent ocular medication.
  • Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear.
  • Clinically significant (Grade 3 or 4) corneal edema, corneal vascularisation, corneal staining, tarsal abnormalities, bulbar injection or any other abnormality of the cornea that would contraindicate contact lens wear.
  • Diabetic.
  • Infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV).
  • Extended lens wear in last 3 months.
  • PMMA or RGP lens wear in the previous 8 weeks.
  • Has had refractive surgery. Has had eye injury/surgery within 8 weeks immediately prior to enrollment for this study.
  • Abnormal lacrimal secretions.
  • Pre-existing ocular irritation that would preclude contact lens fitting.
  • Keratoconus or other corneal irregularity.
  • Pregnancy, lactating or planning a pregnancy at the time of enrollment.
  • Participation in any concurrent clinical trial or in last 60 days."
Both
21 Years to 39 Years
No
Contact information is only displayed when the study is recruiting subjects
Singapore
 
NCT01163760
CR-0706, PRO-518
No
Vistakon
Vistakon
  • Singapore Polytechnic University
  • Visioncare Research Ltd.
Not Provided
Vistakon
March 2014

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