Clinical Trial of Several Contact Lenses in Extended Wear

NCT00762788 | Completed Results

• 1 other identifier: CR-4472
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

Brief Summary

The study is to clinically evaluate currently marketed contact lenses when used in an extended wear modality of up to seven days/six nights.

Conditions

Myopia

Outcome Measures

Primary Outcomes (2)

• Incidence of Corneal Infiltrative Events

  Extended wear is defined as 7 days, 6 nights of lens wear, weekly replacement of lenses. Incidence was calculated as the number of subjects with event divided by the total number of subjects assigned to that lens type.

  52 weeks

• Incidence of Adverse Events

  Occurrence of any Adverse Event by study lens. Incidence was calculated as the number of subjects with event divided by the total number of subjects assigned to that lens type.

  52 weeks

Study Arms (6)

senofilcon A contact lens

ACTIVE COMPARATOR

ACUVUE OASYS

Device: senofilcon A

lotrafilcon A contact lens

ACTIVE COMPARATOR

NIGHT\&DAY

Device: lotrafilcon A

lotrafilcon B contact lens

ACTIVE COMPARATOR

O2Optix

Device: lotrafilcon B

balafilcon A contact lens

ACTIVE COMPARATOR

PureVision

Device: balafilcon A

comfilcon A contact lens

ACTIVE COMPARATOR

Biofinity

Device: comfilcon A

etafilcon A contact lens

ACTIVE COMPARATOR

ACUVUE 2

Device: etafilcon A

Interventions

senofilcon A DEVICE

1 week extended wear contact lens

senofilcon A contact lens

lotrafilcon A DEVICE

1 week extended wear contact lens

lotrafilcon A contact lens

lotrafilcon B DEVICE

1 week extended wear contact lens

lotrafilcon B contact lens

balafilcon A DEVICE

1 week extended wear contact lens

balafilcon A contact lens

comfilcon A DEVICE

1 week extended wear contact lens

comfilcon A contact lens

etafilcon A DEVICE

1 week extended wear contact lens

etafilcon A contact lens

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Be of legal age, and be between 18 and 39 years of age.
• Signed Written Informed Consent and Investigator to record this on Case Report Form (CRF) in appropriate space.
• Require a visual correction in both eyes (Monovision not allowed)
• Require a soft contact lens spherical correction between -0.50 and -9.00D.
• Have an astigmatic correction less than 1.50D in both eyes.
• Be able to wear the lens powers available for this study.
• Be able to regularly wear the lenses on a 7 day/6 night extended wear basis (e.g. does not regularly swim more than once a week)
• Be correctable to a visual acuity of 20/30 or better in each eye.
• Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having:
• No amblyopia.
• No evidence of lid abnormality or infection.
• No clinically significant slit lamp findings
• No other active ocular disease.
• No previous ocular surgery.

You may not qualify if:

• Requires concurrent ocular medication.
• Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear.
• No Clinically significant (Grade 3 or 4) slit lamp findings including corneal edema, corneal vascularization, corneal staining, tarsal abnormalities, bulbar injection, or any other abnormality of the cornea that would contraindicate contact lens wear.
• Diabetic.
• Infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV).
• PMMA or RGP lens wear in the previous 8 weeks.
• Has had refractive surgery. Has had eye injury/surgery within 8 weeks immediately prior to enrolment 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 only.
• Participation in any concurrent clinical trial.
• Currently wearing B\&L PureVision, Ciba O2 Optix, Ciba Night \& Day, CooperVision Biofinity, Vistakon ACUVUE® OASYS, or Vistakon ACUVUE®2 on an EW basis
• Has had previous adverse event(s) contraindicating EW e.g. MK or greater than 2 corneal scars which appear to be contact lens related (e.g. not trauma related).
• Has had an eye injury or surgery within the last eight weeks.

Sponsors & Collaborators

• Johnson & Johnson Vision Care, Inc.: lead

Study Sites (1)

Vision Research Foundation

Chennai, Tamil Nadu, 600 006, India

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Limitations and Caveats

Cautions for results: low completed enrollment numbers and number of non-neophytes lower than required per protocol. Arms not gender matched; Proportion of neophytes/non-neophytes not balanced; High rate of drop-out among subjects enrolled.

Results Point of Contact

• Title: Kathy Osborn, OD, MS, FAAO, FBCLA Senior Principal Research Optometrist
• Organization: Vistakon

kosborn@its.jnj.com

1 904 443-1032

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2008
• First Posted: September 30, 2008
• Study Start: February 1, 2007
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: June 29, 2015
• Results First Posted: May 15, 2015

Record last verified: 2015-06

Locations

IN (1)