A Comparison of Two Contact Lenses

Not Applicable

Completed

Conditions: Refractive Error
Myopia

Interventions: Device: senofilcon A
Device: balafilcon A

Registration Number: NCT00700752

Lead Sponsor: Johnson & Johnson Vision Care, Inc.

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

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 40

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.
They have taken part in any other clinical trial or research, within two weeks prior to starting this study.

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
senofilcon A/balafilcon A	senofilcon A	senofilcon A silicone hydrogel contact lens worn during first 4-week period, balafilcon A silicone hydrogel contact lens worn during the second 4-week period. Senofilcon A lenses worn daily on a 2-week replacement schedule; balafilcon A lenses worn daily on a 4-week replacement schedule. Lens replacement conducted in-office in a masked process.
senofilcon A/balafilcon A	balafilcon A	senofilcon A silicone hydrogel contact lens worn during first 4-week period, balafilcon A silicone hydrogel contact lens worn during the second 4-week period. Senofilcon A lenses worn daily on a 2-week replacement schedule; balafilcon A lenses worn daily on a 4-week replacement schedule. Lens replacement conducted in-office in a masked process.
balafilcon A/senofilcon A	senofilcon A	balafilcon A silicone hydrogel contact lens worn worn during first 4-week period, senofilcon A silicone hydrogel contact lens worn during the second 4-week period. Senofilcon A lenses worn daily on a 2-week replacement schedule; balafilcon A lenses worn daily on a 4-week replacement schedule. Lens replacement conducted in-office in a masked process.
balafilcon A/senofilcon A	balafilcon A	balafilcon A silicone hydrogel contact lens worn worn during first 4-week period, senofilcon A silicone hydrogel contact lens worn during the second 4-week period. Senofilcon A lenses worn daily on a 2-week replacement schedule; balafilcon A lenses worn daily on a 4-week replacement schedule. Lens replacement conducted in-office in a masked process.

Primary Outcome Measures

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

Secondary Outcome Measures