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N/A Completed N=313 Randomized Single-blind Treatment

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

OutcomeResultp-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.
View full record on ClinicalTrials.gov →

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.

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