Two Week Cross-Over Study Comparing Two Daily Disposable Contact Lenses - Full Text View

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:

MedlinePlus related topics: Eye Wear

U.S. FDA Resources

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:	October 5, 2011
Health Authority:	Singapore: independent review board

Additional relevant MeSH terms:

Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on May 16, 2013