N/A
Completed N=313
Clinical Evaluation of Two Daily Disposable Silicone Hydrogel Contact Lenses
Source: ClinicalTrials.gov NCT01634659 ↗Enrolled (actual)
313
Serious AEs
0.0%
Results posted
Nov 2013
Primary outcomePrimary: Overall Comfort — 8.5; 8.6 Units on a scale
Summary
The purpose of this study was to compare the subjective performance of DAILIES TOTAL1® daily disposable contact lenses to that of 1-DAY ACUVUE® TruEye® daily disposable contact lenses.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Comfort |
8.5; 8.6 | — |
| SECONDARY Overall Quality of Vision |
8.6; 8.5 | — |
| SECONDARY End of Day Comfort |
7.7; 7.9 | — |
Eligibility Criteria
Inclusion Criteria
- Sign written Informed Consent Document and HIPAA form.
- Be current weekly/monthly replacement contact lens wearer.
- Be willing to not sleep in contact lenses during the study period.
- Require vision correction in both eyes, with a contact lens prescription in protocol-specified power range.
- Have best corrected visual acuity of at least 20/25 in each eye.
- Be willing to wear study lenses for at least 8 hours/day and at least 5 days/week.
- Use re-wetting drops less than once per day and be willing to discontinue use of rewetting drops while wearing the study contact lenses.
- Other protocol-specified inclusion criteria may apply.
Exclusion Criteria
- Be a neophyte or current wearer of daily disposable lenses.
- Require monovision correction or use multifocal contact lenses.
- Have any systemic or ocular disease or disorder, complicating factor, or structural abnormality that would negatively affect the conduct or outcome of the study.
- Have a history of ocular surgery/trauma within the last 6 months.
- Use topical ocular or systemic antibiotics within 7 days of enrollment.
- Use topical ocular or systemic corticosteroids within 14 days of enrollment, continuing throughout the study.
- Have participated in any other ophthalmic drug or device clinical trial within 30 days of enrollment.
- Have habitually worn contact lenses on an extended wear basis (sleeping in habitual contact lenses for at least 2 nights per week) in the last 3 months prior to enrollment.
- Use re-wetting drops once or more per day.
- Other protocol-defined exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT01634659). 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.