Performance of Two Silicone Hydrogel Toric Contact Lenses

Johnson & Johnson (J&J)

Status: Completed

Conditions: Vision Correction

Treatments: Device: balafilcon A toric; Device: senofilcon A toric

Study type: Interventional

Funder types: Industry

Identifiers

NCT00638846

CR-0801

CTOR-501

Details and patient eligibility

About

Evaluation of the clinical performance of two toric contact lenses in a 2-week, single masked (subject), daily wear, randomized, bilateral, parallel group study.

Enrollment: 276 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Be between 18 and 45 years of age.

• Sign Written Informed Consent (See separate document).

• Be an existing successful daily wear toric soft contact lens.

• Require a visual correction in both eyes (monovision or uniocular fitting is NOT allowed).

• Does not require presbyopic correction (can read J1 @ normal reading distance).

• Have a sphere requirement in the range -1.00 and -5.00D (-5.25D refractive)

• Have refractive astigmatism between 0.75D and 2.50D in both eyes.

• Achieve visual acuity of 20/30 or better in each eye with spherical distance correction.

• 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. stromal edema, vascularisation, infiltrates or abnormal opacities).
  • No other active ocular disease.

Exclusion criteria

• Requires concurrent ocular medication.
• Clinically significant (Grade 3 or 4) corneal stromal haze, corneal vascularisation, tarsal abnormalities, bulbar hyperemia, limbal hyperemia, or any other abnormality of the cornea that would contraindicate contact lens wear.
• Corneal staining Grade 3 in more than one region.
• 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.
• Polymethyl methacrylate (PMMA) or Rigid Gas Permeable (RGP) lens wear in the previous 8 weeks
• Extended lens wear in last 3 months.
• Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear.
• Diabetic.
• Infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV).
• Pregnancy, lactating or planning a pregnancy at the time of enrolment.
• Participation in any concurrent clinical trial or in last 60 days.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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276 participants in 2 patient groups

senofilcon A toric

Experimental group

Description:

senofilcon A, daily wear, toric contact lens worn for two weeks

Treatment:

Device: senofilcon A toric

balafilcon A toric

Active Comparator group

Description:

balafilcon A, daily wear, toric contact lens worn for two weeks

Treatment:

Device: balafilcon A toric