Daytime Corneal Swelling During Wear of Narafilcon B Lenses

NCT01444287 | Completed Results

• 1 other identifier: CR-0918 (JKN 0927)
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Myopia

Outcome Measures

Primary Outcomes (3)

• Corneal Thickness

  Percentage of corneal swelling (positive value) or deswelling (negative value) measured with Haag-Streit pachymetry equipment in microns, reported as a percent.

  After 8 hours of contact lens wear

• Endothelial Blebs

  Corneal images captured with equipment are measured, manually outlined to estimate total bleb area from 0 to 100%. This is measured as a change in percentage after 20 minutes compared to the value prior to lens wear (baseline).

  baseline, after 20 minutes of treatment conditions

• Limbal Redness

  Scale of 0 to 4, where 0=none and 4= severe redness. Measure reported as a comparison of 8 hours of wear to baseline with the difference being reported.

  Baseline, After 8 hours of treatment conditions

Secondary Outcomes (1)

• Overall Comfort

  after 8 hours

Study Arms (4)

Spectacles No Lenses

PLACEBO COMPARATOR

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

Other: Spectacles

narafilcon B

EXPERIMENTAL

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

Device: narafilcon B

polymacon

ACTIVE COMPARATOR

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

Device: Polymacon

lotrafilcon A

ACTIVE COMPARATOR

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

Device: Lotrafilcon A

Interventions

narafilcon B DEVICE

test product

narafilcon B

Polymacon DEVICE

marketed product

polymacon

Lotrafilcon A DEVICE

marketed product

lotrafilcon A

Spectacles OTHER

None - subject used own spectacles

Spectacles No Lenses

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johnson & Johnson Vision Care, Inc.: lead

Study Sites (1)

Coles-Brennan Pty Ltd

Hawthorn, Victoria, Australia

Location

MeSH Terms

Conditions

Myopia

Interventions

Eyeglasses

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Intervention Hierarchy (Ancestors)

Lenses; Optical Devices; Equipment and Supplies

Results Point of Contact

• Title: Noel Brennan
• Organization: Vistakon

nbrenna2@its.jnj.com

1 904 4433494

Study Officials

• Noel Brennan, McOptom PhD

  Coles-Brennan Pty Ltd

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2011
• First Posted: September 30, 2011
• Study Start: January 1, 2010
• Primary Completion: February 1, 2010
• Study Completion: March 1, 2010
• Last Updated: June 19, 2018
• Results First Posted: May 30, 2014

Record last verified: 2015-05

Locations

AU (1)