A Comparison of Two Contact Lenses

Johnson & Johnson Vision Care, Inc.1 site in 1 country40 target enrollmentMay 2008

ConditionsRefractive Error Myopia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Refractive Error
Sponsor: Johnson & Johnson Vision Care, Inc.
Enrollment: 40
Locations: 1
Primary Endpoint: Patient-reported Comfort at at the Manufacturer's Recommended Lens Replacement Timeframe of 2-weeks (Senofilcon A) or 4-weeks (Balafilcon A).
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study seeks to evaluate the clinical and subjective performance of two established soft contact lenses.

Registry

clinicaltrials.gov

Start Date

May 2008

End Date

July 2008

Last Updated

10 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Johnson & Johnson Vision Care, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•They are of legal age (18 years) and capacity to volunteer.
•They understand their rights as a research subject and are willing to sign a Statement of Informed Consent.
•They are willing and able to follow the protocol.
•They would be expected to attain at least 6/9 (20/30) in each eye with the study lenses.
•They are able to wear contact lenses with a back vertex power of -1.00 to -6.00DS.
•They have a maximum of 1.00D of refractive astigmatism (i.e. ≤ 1.00 DC).
•They have successfully worn contact lenses within six months of starting the study.

Exclusion Criteria

•They have an ocular disorder which would normally contra-indicate contact lens wear.
•They have a systemic disorder which would normally contra-indicate contact lens wear.
•They are using any topical medication such as eye drops or ointment.
•They are aphakic.
•They have had corneal refractive surgery.
•They have any corneal distortion resulting from previous hard or rigid lens wear or has keratoconus.
•They are pregnant or lactating.
•They have grade 2 or greater of any of the following ocular surface signs: corneal oedema, corneal vascularisation, corneal staining, tarsal conjunctival changes or any other abnormality which would normally contraindicate contact lens wear.
•They have any infectious disease (e.g. hepatitis) or any immunosuppressive disease (e.g. HIV).
•They have diabetes.

Outcomes

Primary Outcomes

Patient-reported Comfort at at the Manufacturer's Recommended Lens Replacement Timeframe of 2-weeks (Senofilcon A) or 4-weeks (Balafilcon A).

Time Frame: after 4 weeks of lens wear

Subjective rating of overall comfort using a 0 through 5 scale. 0=n/a, 1=poor, 2=fair, 3=good, 4=very good, 5=excellent. Scores from 2-week and 4-week visits were combined for final values.