Clinical Performance of a New Daily Disposable Contact Lens Worn in a Neophyte Population.

Johnson & Johnson Vision Care, Inc.1 site in 1 country74 target enrollmentJune 1, 2008

ConditionsRefractive Error Myopia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Refractive Error
Sponsor: Johnson & Johnson Vision Care, Inc.
Enrollment: 74
Locations: 1
Primary Endpoint: Papillary Conjunctivitis
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study seeks to evaluate the impact of wearing a new daily disposable soft contact lens on the neophyte population.

Registry

clinicaltrials.gov

Start Date

June 1, 2008

End Date

December 1, 2009

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

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

Papillary Conjunctivitis

Time Frame: 12 months

Papillary conjunctivitis which is collected as part of the biomicroscopy data and is identified from a slit lamp examination. Grade 0 to Grade 4 with grade 0 implying no health concerns.

Secondary Outcomes

Biomicroscopy Findings After 12 Months of Daily Wear From Slit Lamp Analysis.(at 12 months)
Visual Acuity After 12 Months of Wear(at 12 months)
Subjective Overall Comfort After 12 Months of Daily Wear(at 12 months)
Subjective Overall Vision After 12 Months of Daily Wear(at 12 months)