Daytime Corneal Swelling During Wear of Narafilcon B Lenses

Sponsors

Lead Sponsor: Johnson & Johnson Vision Care, Inc.

Source Johnson & Johnson Vision Care, Inc.
Brief Summary

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

Overall Status Completed
Start Date January 2010
Completion Date March 2010
Primary Completion Date February 2010
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Corneal Thickness After 8 hours of contact lens wear
Endothelial Blebs baseline, after 20 minutes of treatment conditions
Limbal Redness Baseline, After 8 hours of treatment conditions
Secondary Outcome
Measure Time Frame
Overall Comfort after 8 hours
Enrollment 22
Condition
Intervention

Intervention Type: Device

Intervention Name: narafilcon B

Description: test product

Arm Group Label: narafilcon B

Intervention Type: Device

Intervention Name: Polymacon

Description: marketed product

Arm Group Label: polymacon

Intervention Type: Device

Intervention Name: Lotrafilcon A

Description: marketed product

Arm Group Label: lotrafilcon A

Intervention Type: Other

Intervention Name: Spectacles

Description: None - subject used own spectacles

Arm Group Label: Spectacles No Lenses

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Noel Brennan, McOptom PhD Principal Investigator Coles-Brennan Pty Ltd
Location
Facility: Coles-Brennan Pty Ltd
Location Countries

Australia

Verification Date

May 2015

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 4
Arm Group

Label: Spectacles No Lenses

Type: Placebo Comparator

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

Label: narafilcon B

Type: Experimental

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

Label: polymacon

Type: Active Comparator

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

Label: lotrafilcon A

Type: Active Comparator

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

Study Design Info

Allocation: Randomized

Intervention Model: Crossover Assignment

Primary Purpose: Treatment

Masking: Double (Participant, Investigator)

Source: ClinicalTrials.gov