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

This study has been completed.
Sponsor:
Collaborators:
Johnson & Johnson K.K. Medical Company
Visioncare Research Ltd.
Information provided by (Responsible Party):
Vistakon
ClinicalTrials.gov Identifier:
NCT01155323
First received: June 30, 2010
Last updated: August 16, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention
Myopia
Device: etafilcon A
Device: omafilcon A

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Proclear 1 Day Lens vs 1-Day Acuvue Moist Daily Disposable Contact Lens Crossover Study

Resource links provided by NLM:


Further study details as provided by Vistakon:

Primary Outcome Measures:
  • Subjective Rating of Comfort [ Time Frame: after 1 week of lens wear ] [ Designated as safety issue: No ]
    This outcome is a weighted combined score calculated from individual comfort-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response.

  • Vision Quality [ Time Frame: after 1 week of lens wear ] [ Designated as safety issue: No ]
    This outcome is a weighted combined score calculated from individual vision-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response.

  • Subjective Rating of Handling [ Time Frame: after 1 week of lens wear ] [ Designated as safety issue: No ]
    This outcome is a weighted combined score calculated from individual lens handling-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response.

  • Corneal Staining [ Time Frame: after 1 week of lens wear ] [ Designated as safety issue: Yes ]
    Investigator assessment of the corneal staining. Staining is an indication of dryness on areas on the cornea. Here it is measured over 5 regions of the cornea: central, temporal, nasal, inferior, and superior. The staining is graded using the National Eye Institute (NEI)0-3 scale: grade 0 = normal, grade 1 = mild, grade 2 = moderate, grade 3 = severe.

  • Subjective Rating of Quality Perceptions [ Time Frame: after 1 week of lens wear ] [ Designated as safety issue: No ]
    This outcome is a weighted combined score calculated from individual quality perception-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response.

  • Limbal Hyperemia [ Time Frame: after 1 week of wear ] [ Designated as safety issue: Yes ]
    This outcome is assessed by the investigator during biomicroscopy examination using the following 0-4 scale: 0 = none, 1 = trace, 2 = mild, 3= moderate, 4 = severe.


Enrollment: 118
Study Start Date: March 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: etafilcon A/omafilcon A
etafilcon A contact lenses will be worn during the first week and omafilcon A contact lenses will be worn during the second. Lenses were replaced daily
Device: etafilcon A
1-day soft contact lens
Device: omafilcon A
1-day soft contact lens
Active Comparator: omafilcon A/etafilcon A
omafilcon A contact lenses will be worn during the first week and etafilcon A contact lenses will be worn during the second. Lenses were replaced daily.
Device: etafilcon A
1-day soft contact lens
Device: omafilcon A
1-day soft contact lens

  Eligibility

Ages Eligible for Study:   18 Years to 39 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01155323

Locations
Singapore
Singapore Plytechnic
Singapore, Singapore, 139651
Sponsors and Collaborators
Vistakon
Johnson & Johnson K.K. Medical Company
Visioncare Research Ltd.
Investigators
Principal Investigator: Danny Sim, Diploma in Optometry Singapore Polytechnic
  More Information

No publications provided

Responsible Party: Vistakon
ClinicalTrials.gov Identifier: NCT01155323     History of Changes
Other Study ID Numbers: CR-0926, DISP-523
Study First Received: June 30, 2010
Results First Received: August 29, 2011
Last Updated: August 16, 2013
Health Authority: Singapore: independent review board

Additional relevant MeSH terms:
Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on April 17, 2014