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Vision Correction

Performance of Two Silicone Hydrogel Toric Contact Lenses

Sponsored by Johnson & Johnson Vision Care, Inc.

About this trial

Last updated 10 years ago

Study ID

CR-0801

Status

Completed

Type

Interventional

Phase

N/A

Placebo

No

Accepting

18-75 Years
18 to 45 Years
All
All

Trial Timing

Ended 17 years ago

What is this trial 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.

What are the participation requirements?

Yes

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.
No

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.

Locations

Location

Status