N/A
Completed N=44
Study of ACUVUE® ADVANCE® PLUS Contact Lenses.
Source: ClinicalTrials.gov NCT01244893 ↗Enrolled (actual)
44
Serious AEs
0.0%
Results posted
Feb 2014
Primary outcomePrimary: Visual Acuity (VA) — -0.088; -0.083 logMAR scale
Summary
The purpose of this study is to compare ACUVUE® ADVANCE® Plus contact lenses made prior to process qualification (prePQ) against the ACUVUE® ADVANCE® Plus lenses made after the process qualification (postPQ).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Visual Acuity (VA) |
-0.088; -0.083 | — |
| SECONDARY Corneal Staining |
0.23; 0.17 | — |
| SECONDARY Limbal Redness |
0.71; 0.79 | — |
| SECONDARY Bulbar Redness |
0.71; 0.71 | — |
Eligibility Criteria
Inclusion Criteria
- The subject must be at least 18 years of age and no more than 39 years of age.
- The subject is a current spherical soft contact lens wearer and willing to wear the study lenses on a daily wear basis for the duration of the study (minimum of 6 hours per day).
- The subject's optimal vertexed spherical equivalent distance correction must be between -1.00 and - 5.00D.
- Any cylinder power must be ≤ -0.75D.
- The subject must have visual acuity best correctable to 20/25+3 or better for each eye.
- The subject must read and sign the Statement of Informed Consent.
- The subject 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 or use of medication which might interfere with contact lens wear.
- Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, 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.
- 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.
Data sourced from ClinicalTrials.gov (NCT01244893). 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.