A Comparison of Daily Disposable Contact Lenses.

Johnson & Johnson (J&J)

Status: Completed

Conditions: Myopia

Treatments: Device: narafilcon A; Device: nelfilcon A

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00727558

PROD-501

CR-0808

Details and patient eligibility

About

This study seeks to evaluate the clinical performance of a new CE marked daily disposable contact lens that contains a wetting agent to a recently improved daily disposable contact lens.

Enrollment: 248 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

248 participants in 2 patient groups

narafilcon A

Active Comparator group

Description:

spherical soft contact lens worn as a daily disposable modality for one week

Treatment:

Device: narafilcon A

nelfilcon A

Active Comparator group

Description:

spherical soft contact lens worn as a daily disposable modality for one week

Treatment:

Device: nelfilcon A

Device: narafilcon A