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
  Purpose

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


Condition Intervention
Refractive Error
Device: etafilcon A
Device: ocufilcon D

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

Resource links provided by NLM:


Further study details as provided by Vistakon:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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".


Other Outcome Measures:
  • 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".


Enrollment: 50
Study Start Date: September 2007
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
etafilcon A / ocufilcon D
etafilcon A contact lens worn first daily disposable , ocufilcon D contact lens worn second daily disposable
Device: etafilcon A
daily disposable contact lens
Device: ocufilcon D
daily disposable contact lens
oculfilcon D / etafilcon A
ocufilcon D contact lens worn first, etafilcon A contact lens worn second
Device: etafilcon A
daily disposable contact lens
Device: ocufilcon D
daily disposable contact lens
ocufilcon D / ocufilcon D
ocufilcon D contact lens worn first and second
Device: ocufilcon D
daily disposable contact lens
etafilcon A / etafilcon A
etafilcon A contact lens worn first and second
Device: etafilcon A
daily disposable contact lens

  Eligibility

Ages Eligible for Study:   21 Years to 39 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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."
  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: NCT01163760

Locations
Singapore
Singapore, Singapore
Sponsors and Collaborators
Vistakon
Singapore Polytechnic University
Visioncare Research Ltd.
  More Information

No publications provided

Responsible Party: Vistakon
ClinicalTrials.gov Identifier: NCT01163760     History of Changes
Other Study ID Numbers: CR-0706, PRO-518
Study First Received: September 29, 2008
Results First Received: October 1, 2008
Last Updated: March 14, 2014
Health Authority: Singapore: Clinical Trials & Epidemiology Research Unit (CTERU)

Additional relevant MeSH terms:
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on August 20, 2014