Evaluation of the Performance of Two Contact Lenses Compared to a Marketed Lens
This study has been completed.
Sponsor:
Vistakon
Information provided by (Responsible Party):
Vistakon
ClinicalTrials.gov Identifier:
NCT01484028
First received: November 30, 2011
Last updated: June 4, 2012
Last verified: June 2012
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Purpose
This study will serve to evaluate and compare the performance of two new lenses to a marketed lens.
| Condition | Intervention |
|---|---|
|
Myopia |
Device: etafilcon A control lenses Device: etafilcon A lenses for light eyes Device: etafilcon A for dark eyes lenses |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
Resource links provided by NLM:
Further study details as provided by Vistakon:
Primary Outcome Measures:
- Monocular Visual Acuity [ Time Frame: after one week of lens wear ] [ Designated as safety issue: No ]logMAR scoring/calculations, standard scale
- Lens Fit Acceptance [ Time Frame: after one week of lens wear ] [ Designated as safety issue: No ]Lens fit per eye will evaluated by the investigator and determined to be acceptable or unacceptable
- Corneal Staining of Grade 3 or above [ Time Frame: after one week of lens wear ] [ Designated as safety issue: Yes ]A scale of grades from 0 to 4, where 0=None, 1=Trace, 2=Mild, 3= Moderate, 4=Severe. Percent of eyes with a grade of 3 or 4 will be reported.
| Enrollment: | 275 |
| Study Start Date: | November 2011 |
| Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
etafilcon A for light eyes / etafilcon A control
Subjects will wear etafilcon A for light eyes lenses during the first period and etafilcon A control lenses during the second period. Each period consists of daily lens wear, daily lens replacement for one week.
|
Device: etafilcon A control lenses
marketed etafilcon A lenses for daily wear, daily lens replacement
Device: etafilcon A lenses for light eyes
new etafilcon A lenses designed for light eyes, for daily wear, daily lens replacement
|
|
etafilcon A control / etafilcon A for light eyes
Subjects will wear etafilcon A control lenses during the first period and etafilcon A for light eyes lenses during the second period. Each period consists of daily lens wear, daily lens replacement for one week.
|
Device: etafilcon A control lenses
marketed etafilcon A lenses for daily wear, daily lens replacement
Device: etafilcon A lenses for light eyes
new etafilcon A lenses designed for light eyes, for daily wear, daily lens replacement
|
|
etafilcon A for dark eyes / etafilcon A control
Subjects will wear etafilcon A for dark eyes lenses during the first period and etafilcon A control lenses during the second period. Each period consists of daily lens wear, daily lens replacement for one week.
|
Device: etafilcon A control lenses
marketed etafilcon A lenses for daily wear, daily lens replacement
Device: etafilcon A for dark eyes lenses
new etafilcon A lenses designed for dark eyes, for daily wear, daily lens replacement
|
|
etafilcon A control / etafilcon A for dark eyes
Subjects will wear etafilcon A control lens during the first period and etafilcon A for dark eyes lenses during the second period. Each period consists of daily lens wear, daily lens replacement for one week.
|
Device: etafilcon A control lenses
marketed etafilcon A lenses for daily wear, daily lens replacement
Device: etafilcon A for dark eyes lenses
new etafilcon A lenses designed for dark eyes, for daily wear, daily lens replacement
|
Eligibility| Ages Eligible for Study: | 18 Years to 34 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Healthy, female, adult, at least 18 years of age, and no more than 34 years of age
- Caucasian, Non-Hispanic, habitual soft contact lens wearer (both eyes) with light or dark eyes
- Must have rated the Concept Statement positively (i.e., a rating of 4 or 5).
- Optimal vertexed spherical equivalent distance correction must be between -1.00 and -4.00 diopters (D)
- Any cylinder power must be: <=0.75D
- Visual acuity must be best correctable to 20/25 or better for each eye
- Must have normal eyes (no ocular medications or ocular infection of any type)
- Must read and sign the Statement of Informed Consent
- Must appear able and willing to adhere to the instructions set forth in this clinical protocol.
Exclusion Criteria:
- Ocular or systemic allergies or disease which might interfere with contact lens wear
- Systemic disease, autoimmune disease, or use of medication which might interfere with contact lens wear
- Clinically significant (grade 3 or worse) corneal edema, corneal neovascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear
- Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear
- Any ocular infection
- Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear
- Any color deficiencies (colorblindness) - to the best of the subject's knowledge
- Pregnancy or lactation
- Diabetes
- Infectious diseases (e.g. hepatitis, tuberculosis) or an immuno-suppressive disease (e.g. HIV)
- Habitual contact lens type is toric, multifocal, or is worn as extended wear.
- Subject presents with one dark iris color and one light iris color.
- Subject has heterochromia iridis (a difference in color between parts of one iris).
- The subject must not be an employee or family member of the clinical study site.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01484028
Locations
| United States, California | |
| Site 1 | |
| Mission Viejo, California, United States, 92691 | |
| Site 2 | |
| Mission Viejo, California, United States, 92691 | |
| United States, Florida | |
| Jacksonville, Florida, United States, 32256 | |
| United States, Illinois | |
| Bloomington, Illinois, United States, 61701 | |
| United States, Kansas | |
| Pittsburg, Kansas, United States, 66762 | |
| United States, New York | |
| Vestal, New York, United States, 13850 | |
| United States, Oregon | |
| Grants Pass, Oregon, United States, 97526 | |
| United States, Texas | |
| Katy, Texas, United States, 77450 | |
| United States, Utah | |
| Salt Lake City, Utah, United States, 84106 | |
| United States, Wisconsin | |
| Middleton, Wisconsin, United States, 53562 | |
| United States, Wyoming | |
| Laramie, Wyoming, United States, 82070 | |
Sponsors and Collaborators
Vistakon
More Information
No publications provided
| Responsible Party: | Vistakon |
| ClinicalTrials.gov Identifier: | NCT01484028 History of Changes |
| Other Study ID Numbers: | CR-005094 |
| Study First Received: | November 30, 2011 |
| Last Updated: | June 4, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Myopia Refractive Errors Eye Diseases |
ClinicalTrials.gov processed this record on May 19, 2013