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N/A Completed N=561 Randomized Single-blind

A Comparison of Two Color Contact Lenses in Habitual Clear Contact Lens Wearers

Source: ClinicalTrials.gov NCT01782482 ↗
Enrolled (actual)
561
Serious AEs
0.0%
Results posted
Mar 2014
Primary outcomePrimary: Subjective Rating of Overall Satisfaction — 7.45; 6.91 Units on a scale

Summary

The purpose of this study was to evaluate overall satisfaction with AIR OPTIX® COLORS as compared to FRESHLOOK® COLORBLENDS contact lenses.

Outcome Measures

OutcomeResultp-value
PRIMARY
Subjective Rating of Overall Satisfaction
7.45; 6.91 —
SECONDARY
Positive Purchase Intent
51.7; 42.5 —

Eligibility Criteria

Inclusion Criteria

  • Willing and able to sign Informed Consent Document. If under legal age of consent, legally authorized representative must also sign Informed Consent Document.
  • Able to achieve best corrected visual acuity (BCVA) of 20/25 (Snellen) or better in each eye at distance.
  • Manifest cylinder less than or equal to 0.75 diopter in each eye.
  • Wear contact lenses within protocol-defined specifications.
  • Require spherical contact lenses within the available range of powers.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria

  • Any eye condition that contraindicates contact lens wear.
  • Any systemic or ocular abnormality, infection, or disease likely to affect successful wear of contact lenses or use of their accessory solutions.
  • Moderate or severe ocular findings upon examination.
  • Any use of systemic or ocular medications that could contraindicate contact lens wear, including use of topical ocular medications requiring instillation during contact lens wear, except for approved lubricating drops.
  • Habitual lenses worn in an extended wear modality (routinely sleeping in lenses overnight for 1 night per week or more) over the last 3 months prior to enrollment.
  • Previous corneal or refractive surgery or irregular cornea.
  • Eye injury or surgery within the last 6 months (excluding placement of punctal plugs).
  • Monovision and monocular subjects (only one eye with functional vision) or subjects fit with only one lens.
  • History of intolerance or hypersensitivity to any component of the test articles.
  • Other protocol-defined exclusion criteria may apply.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01782482). 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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