N/A
Completed N=267
Evaluation of the Performance of Two Contact Lenses Compared to a Marketed Lens
Refractive Ametropia
Source: ClinicalTrials.gov NCT01484028 ↗
Enrolled (actual)
267
Serious AEs
0.0%
Results posted
Nov 2013
Primary outcomePrimary: Monocular Visual Acuity — -0.044; -0.060 LogMAR score
Summary
This study will serve to evaluate and compare the performance of two new lenses to a marketed lens.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Monocular Visual Acuity |
-0.044; -0.060 | — |
| PRIMARY Lens Fit Acceptance |
100; 100 | — |
| PRIMARY Corneal Staining of Grade 3 or 4 |
0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy, female adult, at least 18 years of age, and no more than 34 years of age
- The subjects must be female, light eye 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.
Data sourced from ClinicalTrials.gov (NCT01484028). 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. Informational only — not medical advice.