Clinical Performance of a New Daily Disposable Contact Lens Worn in an Established Contact Lens Wearing Population

NCT ID: NCT00708643

Last Updated: 2015-05-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-30
• Study Completion Date: 2008-09-30

Brief Summary

This study seeks to evaluate the clinical and subjective performance of a new daily disposable soft contact lens.

Conditions

Refractive Error; Myopia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Habitual silicone hydrogel

Habitual contact lens wear.

Group Type: ACTIVE_COMPARATOR

Habitual Silicone Hydrogel Contact Lens

Intervention Type: DEVICE

contact lens

narafilcon A

Silicone hydrogel daily disposable contact lens

Group Type: EXPERIMENTAL

narafilcon A

Intervention Type: DEVICE

contact lens

Interventions

Habitual Silicone Hydrogel Contact Lens

contact lens

Intervention Type: DEVICE

narafilcon A

contact lens

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. They are of legal age (17 years) and capacity to volunteer.

2. They understand their rights as a research subject and are willing to sign a Statement of Informed Consent.

3. They are willing and able to follow the protocol.

4. They would be expected to attain at least 6/9 (20/30) in each eye with the study lenses.

5. They are able to wear contact lenses with a back vertex power of -1.00 to -6.00DS.

6. They have a maximum of 1.00D of refractive astigmatism (i.e. ≤ 1.00 DC).

7. They have successfully worn contact lenses within six months of starting the study.

Exclusion Criteria

1. They have an ocular disorder which would normally contra-indicate contact lens wear.

2. They have a systemic disorder which would normally contra-indicate contact lens wear.

3. They are using any topical medication such as eye drops or ointment.

4. They are aphakic.

5. They have had corneal refractive surgery.

6. They have any corneal distortion resulting from previous hard or rigid lens wear or has keratoconus.

7. They are pregnant or lactating.

8. 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.

9. They have any infectious disease (e.g. hepatitis) or any immunosuppressive disease (e.g. HIV).

10. They have diabetes.

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

• Minimum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Manchester

OTHER

Sponsor Role: collaborator

Johnson & Johnson Vision Care, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre for Contact Lens Research

Waterloo, Ontario, Canada

Countries

Canada

Other Identifiers

CR-0803

Identifier Type: -

Identifier Source: org_study_id