Clinical Evaluation of Two Toric Contact Lenses in Current Non-toric Lens Users
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Astigmatism
- Sponsor
- Johnson & Johnson Vision Care, Inc.
- Enrollment
- 200
- Primary Endpoint
- Overall Success in Fitting With a Toric Contact Lens
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the clinical performance, defined as successful fit, of two toric contact lenses (one daily disposable and the other daily wear reusable contact lens to correct astigmatism) in current spherical soft contact lens wearers, contact lens drop-outs, and non-users of toric contact lenses (neophytes).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects must satisfy the following conditions prior to inclusion in the study:
- •One of the following:
- •Spherical contact lens user (minimum of 2 months wear, four days a week, 8 hours a day)
- •Contact Lens drop-out (no contact lens wear in the last 6 months but wearing glasses at least four days a week,8 hours a day)
- •Neophyte (no habitual contact lens wear except for trial fits up to 1 week, but wearing glasses at least four days a week,8 hours a day For patients not currently wearing lenses, patient should have expressed a desire to try lenses.
- •Between 16 and 60 years of age.
- •Have signed an informed consent form (documented by the investigator in the Case Report Form \[CRF\]).
- •Distance requirement in the range of +4.00D to -9.00D (i.e. -10.00D refractive)
- •Refractive astigmatism between -0.75D and -3.00D in both eyes.
- •Have best corrected VA of 6/9 (20/30) or better in each eye.
Exclusion Criteria
- •Any of the following will render a subject ineligible for inclusion:
- •Requires concurrent ocular medication.
- •Clinically significant (Grade 3 or 4) corneal stromal haze, corneal vascularisation, tarsal abnormalities, bulbar hyperaemia, limbal hyperaemia, or any other abnormality of the cornea that would contraindicate contact lens wear.
- •Corneal staining Grade 3 in more than two regions.
- •Extended wear in the last 3 months.
- •Has had any anterior ocular surgery. Has had any other ocular surgery or injury within 8 weeks immediately prior to enrollment for this study.
- •Abnormal lachrymal secretions.
- •Pre-existing ocular irritation that would preclude contact lens fitting.
- •Keratoconus or other corneal irregularity.
- •Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear.
Outcomes
Primary Outcomes
Overall Success in Fitting With a Toric Contact Lens
Time Frame: 4 weeks
Percent of subjects with success with toric lens fitting defined as meeting all of the following pre-determined criteria: 1) acceptable fit, 2) orientation stability less than or equal to 20 degree rotation, 3) binocular visual acuity (VA) within one line of spectacle VA, 4) Good, very good, or excellent overall quality of Vision, and 5) good, very, good, or excellent overall lens comfort. There was not an inferential statistical analysis conducted on this outcome. Comparison was made through the use of 95% CI's for the proportions. Therefore no statistical analysis section is included for this primary outcome.
Distance Visual Acuity
Time Frame: after 1 week of toric contact lens wear
Measured monocularly (each eye separately) in Snellen converted to logMAR units. The logMAR scale has a range of -0.30 to 1.00. A value of 0 or less would not require distance vision correction and a value of 0 or greater may require distance vision correction.
Distance Visual Acuity (VA)
Time Frame: after 4 weeks of toric contact lens wear
Visual Acuity is measured monocularly (each eye separately) in Snellen, the converted to logMAR units. The logMAR scale has a range of -0.30 to 1.00. A value of 0 or less would not require distance vision correction and a value of 0 or greater may require distance vision correction.