In-office Evaluation of Two Toric Soft Contact Lenses and a Spherical Soft Contact Lens
May 5, 2015 updated by: Johnson & Johnson Vision Care, Inc.
Evaluation of Fit and Visual Acuity of the Cypress Toric Lens in Two Phases: Part A: A Non-Dispensing Comparison to SofLens66® Toric and Acuvue® 2
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Non-dispensing, single-masked (subject-masked), randomised, controlled study.
Study Type
Interventional
Enrollment (Actual)
96
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 39 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: senofilcon A/alphafilcon A/etafilcon A
First intervention:senofilcon A toric contact lenses Second intervention: alphafilcon A toric contact lenses Third intervention: etafilcon A sphere contact lenses
|
contact lens
contact lens
contact lens
|
|
Active Comparator: alphafilcon A/etafilcon A/senofilcon A
First intervention: alphafilcon A toric contact lenses Second intervention: etafilcon A sphere contact lenses Third intervention: senofilcon A toric contact lenses
|
contact lens
contact lens
contact lens
|
|
Active Comparator: etafilcon A/senofilcon A/alphafilcon A
First intervention: etafilcon A sphere contact lenses Second intervention:senofilcon A toric contact lenses Third intervention: alphafilcon A toric contact lenses
|
contact lens
contact lens
contact lens
|
|
Active Comparator: senofilcon A/etafilcon A/alphafilcon A
First intervention: senofilcon A toric contact lenses Second intervention: etafilcon A sphere contact lenses Third intervention: alphafilcon A toric contact lenses
|
contact lens
contact lens
contact lens
|
|
Active Comparator: alphafilcon A/senofilcon A/etafilcon A
First intervention: alphafilcon A toric contact lenses Second intervention: senofilcon A toric contact lenses Third intervention: etafilcon A sphere contact lenses
|
contact lens
contact lens
contact lens
|
|
Active Comparator: etafilcon A/alphafilcon A/senofilcon A
First intervention: etafilcon A sphere contact lenses Second intervention: alphafilcon A toric contact lenses Third intervention: senofilcon A toric contact lenses
|
contact lens
contact lens
contact lens
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Acuity
Time Frame: 15-20 minutes
|
Number of eyes with Distance Visual Acuity 20/20 or better
|
15-20 minutes
|
|
Patient Reported Vision
Time Frame: 15-20 minutes
|
A weighted combined score calculated from individual confort-vision related questions asked on a 1-5 scale, 1=most negative resonse to 5=most positive response, was used to derive vision scores.
The analysis shows the difference in outcome between test and control.
>0=greater vision, <0=lesser vision.
|
15-20 minutes
|
|
Lens Orientation Within 5 Degrees
Time Frame: 1 minute
|
Meaures in what position does the lens sit on the eye at insertion and is measured in degrees of rotation.
|
1 minute
|
|
Lens Stability Within 5 Degrees
Time Frame: 1 minute
|
Measures if the lens changes position on the eye as it is worn and is measured in degrees of rotation.
|
1 minute
|
|
Patient Reported Comfort.
Time Frame: 15-20 minutes
|
A weighted combined score calculated from individual comfort-related questions asked on a 1-5 scale, 1=most negative response to 5=most positive response, was used to derive comfort outcomes.
The analysis shows the difference in outcome between the test and control.
>0=comfortable, <0=uncomfortable
|
15-20 minutes
|
|
Patient Preference
Time Frame: end of study
|
This outcome measures which lens the subjects preferred to wear.
|
end of study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Jason Chin, O.D.
- Principal Investigator: James Fujimoto, O.D.
- Principal Investigator: Weslie Hamada, OlD., Arthur T. Kobayashi, O.D., Inc.
- Principal Investigator: Dennis Kuwuabara, O.D., Eye Care Associates of Hawaii
- Principal Investigator: Mark Nakano, O.D., Mark E. Nakano Optometric Corp.
- Principal Investigator: Ikuko Sugimoto, O.D.
- Principal Investigator: Kevin Rosin, O.D., Drs. Farkas, Kassalow, Resnick & Associates
- Principal Investigator: Jennifer Kao, O.D.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2007
Primary Completion (Actual)
November 1, 2007
Study Completion (Actual)
November 1, 2007
Study Registration Dates
First Submitted
December 20, 2007
First Submitted That Met QC Criteria
December 31, 2007
First Posted (Estimate)
January 2, 2008
Study Record Updates
Last Update Posted (Estimate)
May 21, 2015
Last Update Submitted That Met QC Criteria
May 5, 2015
Last Verified
May 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR-0714A
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.