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Clinical Evaluation of Two Daily Disposable Contact Lenses

This study has been completed.
Sponsor:
Collaborators:
Singapore Polytechnic
Visioncare Research Ltd.
Information provided by (Responsible Party):
Vistakon
ClinicalTrials.gov Identifier:
NCT01163760
First received: September 29, 2008
Last updated: November 7, 2011
Last verified: November 2011
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Vistakon:

Primary Outcome Measures:
  • Lens Comfort [ Time Frame: Change from baseline to one 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

    Analysis was performed at the 1 week time point.



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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01163760

Locations
Singapore
Singapore, Singapore
Sponsors and Collaborators
Vistakon
Singapore Polytechnic
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: November 7, 2011
Health Authority: Singapore: Clinical Trials & Epidemiology Research Unit (CTERU)

Additional relevant MeSH terms:
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on May 19, 2013