N/A
N=87
Evaluation of Two Toric Soft Contact Lenses After Two Weeks of Wear
Astigmatism
Bottom Line
View on ClinicalTrials.gov: NCT00584220 ↗Enrolled (actual)
87
Serious AEs
0.0%
Results posted
Feb 2010
Primary outcome: Primary: Subjective Reported Vision — 0.33; -0.17 Units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- senofilcon A toric (Device); alphafilcon A toric (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johnson & Johnson Vision Care, Inc.
- Primary completion
- Dec 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Subjective Reported Vision |
0.33; -0.17 | — |
| PRIMARY Subject Reported Lens Comfort. |
0.37; -0.38 | — |
Summary
The purpose of this study is to determine the relative performance of a new toric soft contact lens against a toric contact lens currently available in market, specifically with regards to the comfort and vision after two weeks of use.
Eligibility Criteria
Inclusion Criteria: Prior to being considered eligible to participate in this study, subjects MUST
- 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 (NCT00584220). 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.