In-office Evaluation of Two Toric Soft Contact Lenses and a Spherical Soft Contact Lens
This study has been completed.
Sponsor:
Vistakon
Collaborator:
Foresight Regulatory Strategies, Inc.
Information provided by:
Vistakon
ClinicalTrials.gov Identifier:
NCT00584727
First received: December 20, 2007
Last updated: May 13, 2013
Last verified: May 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Astigmatism |
Device: senofilcon A toric contact lens Device: alphafilcon A toric Device: etafilcon A sphere |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by Vistakon:
Primary Outcome Measures:
- Visual Acuity [ Time Frame: 15-20 minutes ] [ Designated as safety issue: No ]Number of eyes with Distance Visual Acuity 20/20 or better
- Patient Reported Vision [ Time Frame: 15-20 minutes ] [ Designated as safety issue: No ]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.
- Lens Orientation Within 5 Degrees [ Time Frame: 1 minute ] [ Designated as safety issue: No ]Meaures in what position does the lens sit on the eye at insertion and is measured in degrees of rotation.
- Lens Stability Within 5 Degrees [ Time Frame: 1 minute ] [ Designated as safety issue: No ]Measures if the lens changes position on the eye as it is worn and is measured in degrees of rotation.
- Patient Reported Comfort. [ Time Frame: 15-20 minutes ] [ Designated as safety issue: No ]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
- Patient Preference [ Time Frame: end of study ] [ Designated as safety issue: No ]This outcome measures which lens the subjects preferred to wear.
| Enrollment: | 96 |
| Study Start Date: | September 2007 |
| Study Completion Date: | November 2007 |
| Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Device: senofilcon A toric contact lens
contact lens
Device: alphafilcon A toric
contact lens
Device: etafilcon A sphere
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
|
Device: senofilcon A toric contact lens
contact lens
Device: alphafilcon A toric
contact lens
Device: etafilcon A sphere
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
|
Device: senofilcon A toric contact lens
contact lens
Device: alphafilcon A toric
contact lens
Device: etafilcon A sphere
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
|
Device: senofilcon A toric contact lens
contact lens
Device: alphafilcon A toric
contact lens
Device: etafilcon A sphere
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
|
Device: senofilcon A toric contact lens
contact lens
Device: alphafilcon A toric
contact lens
Device: etafilcon A sphere
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
|
Device: senofilcon A toric contact lens
contact lens
Device: alphafilcon A toric
contact lens
Device: etafilcon A sphere
contact lens
|
Detailed Description:
Non-dispensing, single-masked (subject-masked), randomised, controlled study.
Eligibility| Ages Eligible for Study: | 18 Years to 39 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00584727
Sponsors and Collaborators
Vistakon
Foresight Regulatory Strategies, Inc.
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. |
More Information
No publications provided
| Responsible Party: | Kurt Moody, OD, FAAO./ Manager, Clinical Research, Vistakon |
| ClinicalTrials.gov Identifier: | NCT00584727 History of Changes |
| Other Study ID Numbers: | CR-0714A |
| Study First Received: | December 20, 2007 |
| Results First Received: | December 5, 2008 |
| Last Updated: | May 13, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Vistakon:
|
astigmatism visual acuity fit |
comfort satisfaction contact lens |
Additional relevant MeSH terms:
|
Astigmatism Refractive Errors Eye Diseases |
ClinicalTrials.gov processed this record on May 21, 2013