N/A
N=96
In-office Evaluation of Two Toric Soft Contact Lenses and a Spherical Soft Contact Lens
Astigmatism
Bottom Line
View on ClinicalTrials.gov: NCT00584727 ↗Enrolled (actual)
96
Serious AEs
0.0%
Results posted
Feb 2010
Primary outcome: Primary: Visual Acuity — 146; 136; 37 Eyes with Snellen VA 20/20 or better — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- senofilcon A toric contact lens (Device); alphafilcon A toric (Device); etafilcon A sphere (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johnson & Johnson Vision Care, Inc.
- Primary completion
- Nov 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Visual Acuity |
146; 136; 37 | <0.0001 sig |
| PRIMARY Patient Reported Vision |
0.2845; 0.1332; -0.4310 | — |
| PRIMARY Lens Orientation Within 5 Degrees |
142; 126 | 0.2161 |
| PRIMARY Lens Stability Within 5 Degrees |
156; 140 | 0.1328 |
| PRIMARY Patient Reported Comfort. |
0.1425; -0.3464; 0.2176 | — |
| PRIMARY Patient Preference |
62; 5; 18 | <0.0001 sig |
Summary
The purpose of this study is to determine the relative performance of a new toric soft contact lens against a toric and a spherical contact lens currently available in market, specifically with regards to the fit and visual acuity as well as the comfort, vision and satisfaction while in the practitioner's office. Approximately 2 hours duration.
Eligibility Criteria
Inclusion Criteria
- be at least 18 and less than or equal to 39 years of age and have a need for vision correction in BOTH eyes (monovision or uniocular fitting is NOT allowed).
- be of Asian descent (Japanese, Chinese, Korean, Polynesian or other Asian ancestry) and have Asian Eye anatomy
- have successfully worn toric or spherical soft (hydrogel or silicone hydrogel) contact lenses for at least 4-weeks prior to enrollment in the study.
- be able and willing to adhere to the instructions set forth in the protocol.
- agree to wear their contact lenses in both eyes on a daily wear schedule for at least 8 hours per day every day during the study.
- have a distance spherical component between -1.00 D and -5.50 D with cylinder in the range of 0.75 D to 2.25 D and cylinder axis within 10 ° of the vertical and within 20 ° of the horizontal in both eyes
- have a best corrected manifest refraction visual acuity of at least 20/25 or better in each eye.
- be in good general health, based on his/her knowledge.
- read, be given an explanation of, indicate understanding of, and sign the STATEMENT OF INFORMED CONSENT.
Exclusion Criteria
- The subject is a rigid gas permeable (RGP) or daily disposable soft lens wearer.
- The presence of clinically significant (grade 3 or 4) anterior segment abnormalities; inflammations such as iritis; or any infection of the eye, lids, or associated structures.
- The presence of ocular or systemic disease or need for medication which might interfere with contact lens wear or which would cause the lenses to be removed more than twice a day. (i.e., Sjögren's syndrome, type II diabetes, etc).
- Slit lamp findings that would contraindicate contact lens wear such as:
- Pathological dry eye or associated findings
- Pterygium or corneal scars within the visual axis
- Neovascularization >1mm in from the limbus
- History of giant papillary conjunctivitis (GPC) worse than Grade 2
- Anterior uveitis or iritis (past or present)
- Seborrhoeic eczema, seborrhoeic conjunctivitis
- A history of recurrent erosions, corneal infiltrates, corneal ulcer or fungal infections.
- A known history of corneal hypoesthesia (reduced corneal sensitivity.)
- Aphakia, keratoconus or a highly irregular cornea.
- Current pregnancy or lactation (to the best of the subject's knowledge).
- Active participation in another clinical study at any time during this study.
Data sourced from ClinicalTrials.gov (NCT00584727). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.