Evaluation of DW Silicone Hydrogel Lens Compared to DW Silicone Hydrogel Lens
This study has been completed.
Sponsor:
Coopervision, Inc.
Information provided by (Responsible Party):
Coopervision, Inc.
ClinicalTrials.gov Identifier:
NCT01386008
First received: May 22, 2011
Last updated: October 12, 2012
Last verified: October 2012
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Purpose
The purpose of this study is to evaluate the performance of the investigational CooperVision silicone hydrogel lens compared to a currently-marketed silicone hydrogel contact lens up to 30 days of daily lens wear.
| Condition | Intervention |
|---|---|
|
Myopia |
Device: senfilcon A contact lens Device: investigational enfilcon A |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
Resource links provided by NLM:
Further study details as provided by Coopervision, Inc.:
Primary Outcome Measures:
- Change from baseline in subjective response while wearing and handling the lens [ Time Frame: Initial, 1 week, 2 week, 30 day ] [ Designated as safety issue: No ]The subjects will complete a questionnaire
Secondary Outcome Measures:
- Lens fitting characteristics [ Time Frame: Initial, 1 week, 2 week, 30 day ] [ Designated as safety issue: No ]The lens fitting characteristics will be evaluated by a doctor using a biomicroscope.
- Ocular physiological response [ Time Frame: Initial, 1 week, 2 week, 30 day ] [ Designated as safety issue: Yes ]The front surface of the eyes will be examined by a doctor after lens removal of the lens.
| Enrollment: | 72 |
| Study Start Date: | May 2011 |
| Study Completion Date: | November 2011 |
| Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: investigational enfilcon A
investigational enfilcon A contact lenses worn daily wear
|
Device: investigational enfilcon A
investigational enfilcon A, worn daily wear modality
|
|
Active Comparator: senfilcon A contact lens
senofilcon A contact lens worn daily wear
|
Device: senfilcon A contact lens
senofilcon A spherical contact lens worn in a daily wear modality
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Be at least 18 years of age as of the date of evaluation for the study.
- Not using any ocular medications
- Have a self-reported full eye examination within 2 years.
Have:
- read the Informed Consent
- be given an explanation of the Informed Consent
- indicate understanding of the Informed Consent
- signed the Informed Consent document.
- Be willing and able to adhere to the instructions set forth in this protocol and able to keep all specified appointments.
- Be an adapted, current full-time silicone hydrogel or soft contact lens wearer. An adapted full-time wearer is defined as wearing contact lenses on a daily basis for at least 8 hours per day for at least one month prior to participation in the study.
- Possess wearable and visually functional eyeglasses.
- Be in good general health, based on his/her knowledge.
- Require spectacle lens powers between -1.00 and -6.00 diopters sphere with no more than 0.75 diopter of refractive astigmatism in order to have the best spherical equivalent power of -6.50 or less.
- Be willing to wear contact lenses in both eyes.
- Have manifest refraction Snellen visual acuities (VA) equal to or better than 20/25 (less than or equal to LogMAR 0.10) in each eye.
- Upon completing the fitting process with the lenses to be worn in the study, have contact lens Snellen VA equal to or better than 20/30 in each eye.
Exclusion Criteria:
- Wearing lenses in a monovision modality and is unwilling to be fit with distance lenses in both eyes. NOTE: Subjects may not wear lenses in a monovision modality at any time during the study as it will interfere with the visual acuity analysis.
- Any active participation in another one-day clinical trial within 7 days prior to this study or another dispensing trial within 30 days prior to this study.
- Currently pregnant (to the best of the subject's knowledge), is lactating or is planning a pregnancy within the next month.
- Has a known sensitivity to ingredients used in the over the counter contact lens care approved for use in the study.
- Previous refractive surgery/anterior segment surgery; or current or previous orthokeratology treatment or irregular cornea.
- Is aphakic or pseudophakic.
- Unable to achieve a satisfactory fit with the lens designs used in the study
- Ocular or systemic disease such as, but not limited to: anterior uveitis or iritis (past or present), glaucoma, Sjögren's syndrome, lupus erythematosus, sclerodermia, keratoconus or type II diabetes.
- The need for topical ocular medications or any medication which might contradict contact lens wear or which would require the lenses to be removed during the day.
- The presence of clinically anterior segment infection, inflammations or abnormalities; such as iritis; or any infection of the eye, lids, or associated structures.
- A history of herpetic keratitis.
- A known history of corneal hypoesthesia (reduced corneal sensitivity) or active corneal ulcer, corneal infiltrates or fungal infection.
- A history of papillary conjunctivitis that has interfered with contact lens wear.
Slit lamp findings that would contraindicate contact lens wear, including but not limited to:
- Pathological dry eye or associated dry eye symptoms with decreased tear levels and punctuate staining > grade 2
- Pterygium
- Corneal scars within the visual axis
- Corneal edema or corneal staining ≥ grade 2
- Neovascularization or ghost vessels > 1.0 mm in from the limbus
- Giant papillary conjunctivitis (GPC) of > grade 2.
- Seborrheic eczema, seborrheic conjunctivitis or blepharitis
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01386008
Locations
| United States, California | |
| Clinical Research Center, University of California, Berkeley | |
| Berkeley, California, United States, 94704 | |
| United Kingdom | |
| University of Manchester | |
| Manchester, United Kingdom, M13 9PL | |
Sponsors and Collaborators
Coopervision, Inc.
More Information
No publications provided
| Responsible Party: | Coopervision, Inc. |
| ClinicalTrials.gov Identifier: | NCT01386008 History of Changes |
| Other Study ID Numbers: | CV-10-50 |
| Study First Received: | May 22, 2011 |
| Last Updated: | October 12, 2012 |
| Health Authority: | United States: Food and Drug Administration United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Additional relevant MeSH terms:
|
Myopia Refractive Errors Eye Diseases |
ClinicalTrials.gov processed this record on May 21, 2013