N/A
Completed N=36
Pilot Dispensing Evaluation of a Plus Power Lens
Source: ClinicalTrials.gov NCT01228591 ↗Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Feb 2014
Primary outcomePrimary: Visual Acuity One Week After Lens Wear — 0.11; 0.10; 0.14; 0.14 LogMAR
Summary
The purpose of this study is to compare the performance of the ACUVUE® ADVANCE® Plus lenses against ACUVUE® ADVANCE® lenses in the plus power parameters.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Visual Acuity One Week After Lens Wear |
0.11; 0.10; 0.14; 0.14; 0.12; 0.13 | — |
| PRIMARY Visual Acuity at Time of Initial Fit |
0.13; 0.11; 0.16; 0.15; 0.14; 0.13 | — |
| SECONDARY Contact Lens Comfort Using Contact Lens User Experience (CLUE) |
49.2; 50.7 | — |
| SECONDARY Subject Reported Vision Using Contact Lens User Experience (CLUE). |
42.5; 39.9 | — |
| SECONDARY Contact Lens Comfort at Initial Fit Using Contact Lens User Experience (CLUE) |
65.3; 59.0 | — |
| SECONDARY Subject Reported Vision at Initial Fit Using Contact Lens User Experience (CLUE) |
46.7; 49.6 | — |
Eligibility Criteria
Inclusion Criteria
- The subject must be at least 18 years of age and no more than 45 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 (defined as a minimum of 6 hours with a minimum of at least 1 month's wear prior to the study).
- The subject's optimal verified spherical equivalent distance correction must be between +1.00 and + 6.00D.
- 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 the 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, bifocal, in monovision contact lens wear, or is worn as extended wear.
- Need any near correction.
Data sourced from ClinicalTrials.gov (NCT01228591). 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.