Clinical Evaluation of Two Daily Disposable Contact Lenses

Johnson & Johnson (J&J)

Status: Completed

Conditions: Refractive Error

Treatments: Device: etafilcon A; Device: ocufilcon D

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01163760

CR-0706

PRO-518

Details and patient eligibility

About

This study seeks to evaluate the clinical performance of two daily disposable contact lenses.

Enrollment: 50 patients

Sex: All

Ages: 21 to 39 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Be between 21 and 39 years of age.

• Signed Written Informed Consent and Investigator to record this on Case Report Form (CRF) in appropriate space.

• Be existing (i.e. successfully worn for 1-month prior to the study) soft contact lens wearers (no extended wear in the last 3 months, but silicone hydrogels in daily wear are allowed).

• Require a visual correction in both eyes (monovision allowed but no monofit).

• Have a contact lens spherical distance requirement between -1.00D and -6.00D in both eyes.

• Astigmatism of 1.00D or less in both eyes.

• Be able to wear the lens powers available for this study.

• 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 conjunctival abnormality or infection.
  • No clinically significant slit lamp findings (i.e. edema, staining, scarring, vascularisation, infiltrates or abnormal opacities).
  • No other active ocular disease.

Exclusion criteria

• 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.
• Clinically significant (Grade 3 or 4) corneal edema, corneal vascularisation, 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).
• Extended lens wear in last 3 months.
• 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 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 or in last 60 days."

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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50 participants in 4 patient groups

etafilcon A / ocufilcon D

Other group

Description:

etafilcon A contact lens worn first daily disposable , ocufilcon D contact lens worn second daily disposable

Treatment:

Device: etafilcon A

Device: ocufilcon D

oculfilcon D / etafilcon A

Other group

Description:

ocufilcon D contact lens worn first, etafilcon A contact lens worn second

Treatment:

Device: etafilcon A

Device: ocufilcon D

ocufilcon D / ocufilcon D

Other group

Description:

ocufilcon D contact lens worn first and second

Treatment:

Device: ocufilcon D

etafilcon A / etafilcon A

Other group

Description:

etafilcon A contact lens worn first and second

Treatment:

Device: etafilcon A