Status:

COMPLETED

Two Week Cross-Over Study Comparing Two Daily Disposable Contact Lenses

Lead Sponsor:

Johnson & Johnson Vision Care, Inc.

Collaborating Sponsors:

Johnson & Johnson K.K. Medical Company

Visioncare Research Ltd.

Conditions:

Myopia

Eligibility:

All Genders

18-39 years

Phase:

NA

Brief Summary

This study seeks to evaluate and compare the clinical performance of two daily disposable soft contact lenses, Proclear 1 Day and 1-Day Acuvue Moist.

Eligibility Criteria

Inclusion

  • At least 18 years of age and no more than 39 years of age
  • Existing soft contact lens wearers
  • Willing to signed a written Informed Consent.
  • Own a mobile phone and are willing to receive and reply to Short Message Service (SMS) messages during the day.
  • Have a contact lens spherical distance requirement between -1.00 diopters (D) and -6.00 diopters (D) in both eyes.
  • Have an Astigmatism of 1.00D or less in both eyes.
  • Require a visual correction in both eyes.
  • Be correctable to a visual acuity of 6/9 (20/30) or better in each eye.
  • Have normal eyes with no evidence of abnormality or disease that would preclude lens wear.

Exclusion

  • Clinically significant (Grade 3 or 4) corneal edema, corneal vascularization, tarsal abnormalities, bulbar infection, or any other abnormality of the cornea that would contraindicate contact lens wear.
  • Clinically significant corneal staining (Grade 3 in more than one region).
  • Keratoconus or other corneal irregularity.
  • Abnormal lachrymal secretions.
  • Extended wear of contact lenses last 3 months.
  • Polymethyl methacrylate (PMMA) or rigid gas-permeable (RGP) lens wear in the previous 8 weeks.
  • Refractive surgery.
  • Eye injury/surgery within 8 weeks immediately prior to enrollment for this study.
  • Pre-existing ocular irritation that would preclude contact lens fitting.
  • Require concurrent ocular medication
  • Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear.
  • Any infectious disease (e.g., hepatitis, tuberculosis) or any immunosuppressive disease (e.g., HIV).
  • Diabetes.
  • Pregnant, lactating or planning a pregnancy at the time of enrollment.
  • Participation in any concurrent clinical trial or in last 30 days.

Key Trial Info

Start Date :

March 1 2010

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 1 2010

Estimated Enrollment :

118 Patients enrolled

Trial Details

Trial ID

NCT01155323

Start Date

March 1 2010

End Date

June 1 2010

Last Update

June 19 2018

Active Locations (1)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (1 locations)

1

Singapore Plytechnic

Singapore, Singapore, 139651