Daytime Corneal Swelling During Wear of Narafilcon B Lenses

NCT ID: NCT01444287

Last Updated: 2018-06-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2010-03-31

Brief Summary

The purpose of this research is to measure daytime open-eye response to wearing of narafilcon B lenses.

Conditions

Myopia

Study Design

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

Study Groups

Spectacles No Lenses

Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.

Group Type: PLACEBO_COMPARATOR

Spectacles

Intervention Type: OTHER

None - subject used own spectacles

narafilcon B

Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.

Group Type: EXPERIMENTAL

narafilcon B

Intervention Type: DEVICE

test product

polymacon

Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.

Group Type: ACTIVE_COMPARATOR

Polymacon

Intervention Type: DEVICE

marketed product

lotrafilcon A

Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.

Group Type: ACTIVE_COMPARATOR

Lotrafilcon A

Intervention Type: DEVICE

marketed product

Interventions

narafilcon B

test product

Intervention Type: DEVICE

Polymacon

marketed product

Intervention Type: DEVICE

Lotrafilcon A

marketed product

Intervention Type: DEVICE

Spectacles

None - subject used own spectacles

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Be of legal age (i.e. ≥ 18 years).
• Be mentally competent, willing and able to sign a written informed consent form.
• Have contact lens distance sphere requirement in the range -1.00D to -6.00D.
• Have spectacle astigmatism <1.25D in each eye.
• Currently wear soft contact lenses (for at least 6 months prior to the trial) with documentation of current prescription.
• Have normal eyes with no evidence of abnormality or disease. For the purpose of this study a normal eye is defined as one having: i) no evidence of lid abnormality or infection; ii) no conjunctival abnormality or infection; iii) no clinically significant slit lamp findings (i.e, edema, staining, scarring, vascularization, infiltrates or abnormal opacities); iv) no other active ocular disease.

Exclusion Criteria

• Required concurrent ocular medication.
• Any systemic illness which would contra-indicate lens wear or the medical treatment of which would affect vision or successful lens wear.
• Eye injury or surgery within eight weeks immediately prior to enrollment for this study.
• Abnormal lacrimal secretions.
• Pre-existing ocular irritation that would preclude contact lens fitting.
• Keratoconus or other corneal irregularity.
• Pregnancy, lactating or planning a pregnancy at the time of enrollment.
• Participation in any concurrent clinical trial.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johnson & Johnson Vision Care, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Noel Brennan, McOptom PhD

Role: PRINCIPAL_INVESTIGATOR

Coles-Brennan Pty Ltd

Locations

Coles-Brennan Pty Ltd

Hawthorn, Victoria, Australia

Countries

Australia

Other Identifiers

CR-0918 (JKN 0927)

Identifier Type: -

Identifier Source: org_study_id