N/A
N=42
Comparative Evaluation of Contact Lens Centering of DAILIES® AquaComfort Plus® Versus 1-DAY ACUVUE® MOIST® in Japan
Refractive Error · Myopia · Myopic Astigmatism
Bottom Line
View on ClinicalTrials.gov: NCT02103309 ↗Enrolled (actual)
42
Serious AEs
0.0%
Results posted
Oct 2014
Primary outcome: Primary: Mean Investigator-Rated Lens Centration — 0.34; 0.73 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Nelfilcon A contact lenses (Device); Etafilcon A contact lenses (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Alcon Research
- Primary completion
- Nov 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Investigator-Rated Lens Centration |
0.34; 0.73 | — |
| SECONDARY Mean Investigator-Rated Lens Fit |
0.24; 0.28 | — |
| SECONDARY Average Subjective Ratings Score (Lens Handling and Overall Vision) |
7.8; 6.4; 7.2; 8.2; 8.1; 7.4 | — |
| SECONDARY Average Subjective Ratings Score (Lens Wearing Conditions and Visual Performance During Ball Sports) |
3.5; 3.8; 2.4; 2.5; 3.3; 4.0 | — |
Summary
The purpose of this study is to evaluate lens centration and subjective impressions of DAILIES® AquaComfort Plus® (DACP) lenses compared to 1-DAY ACUVUE® MOIST® (1DAM) lenses in ball sports players.
Eligibility Criteria
Inclusion Criteria
- Those who can understand the clinical study objectives and provide written informed consent. Legal representative or parental consent required if under age 20
- Those who regularly wear soft contact lenses in both eyes for a minimum of 8 hours per day and 5 days per week
- Those who play ball sports at least 1 day per week
- Those who need vision correction because of myopia or mild myopic astigmatism, who are eligible for use of the study device, and who can attain a visual acuity of at least 1.0 with correction
- Other protocol-defined inclusion criteria may apply
Exclusion Criteria
- Those who regularly wear the study device
- Those who require ocular treatment with eye drops
- Those who have a condition contraindicating soft contact lens wear, such as eye irritation
- Those who have had ocular disorder or ocular surgery that may affect soft contact lens wear within 3 months before the start of the study
- Those who are participating in another clinical study or research or have a plan of such participation during the present study
- Women who are pregnant or intend to become pregnant during the study
- Other protocol-defined exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT02103309). 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.