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
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: 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

ClinicalTrials.gov processed this record on October 29, 2014