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N/A Completed N=251 Randomized

A Comparison of Silicone Hydrogel Contact Lenses: AIR OPTIX® COLORS Versus AIR OPTIX® AQUA

Source: ClinicalTrials.gov NCT01635920 ↗
Enrolled (actual)
251
Serious AEs
0.0%
Results posted
Mar 2014
Primary outcomePrimary: Percentage of Subjects With Same Fit in Both Eyes — 99.2; 100; 99.2; 99.2 percentage of participants

Summary

The purpose of this study was to compare the overall fit of AIR OPTIX® COLORS to AIR OPTIX® AQUA contact lenses.

Outcome Measures

OutcomeResultp-value
PRIMARY
Percentage of Subjects With Same Fit in Both Eyes
99.2; 100; 99.2; 99.2 —
SECONDARY
Subjective Rating of Overall Comfort
8.4; 8.9; 8.5; 8.9 —

Eligibility Criteria

Inclusion Criteria

  • Visual acuity of at least 20/30 (Snellen) in each eye at distance with contact lenses and best corrected visual acuity ≥ 20/25 in each eye.
  • Manifest cylinder less than or equal to 0.75 diopter (D) (within the previous year) in each eye.
  • Successful wear of AIR OPTIX® AQUA soft contact lenses in both eyes during the past 3 months for a minimum of 5 days per week and 8 hours per day.
  • Willing to sign an Informed Consent form. If under legal age of consent, legally authorized representative must also sign an Informed Consent form.
  • Other protocol-specified inclusion criteria may apply.

Exclusion Criteria

  • Any ocular or systemic medical condition that may, in the opinion of the investigator, preclude safe administration of the test articles or affect the results of this study.
  • Wears habitual lenses in an extended wear modality (sleeping in lenses overnight / not removing lenses on a daily basis).
  • Monovision, monocular (only one eye with functional vision), or fit with only one lens.
  • History of intolerance or hypersensitivity to any component of the test articles.
  • Use of any over-the-counter (OTC) or prescribed topical ocular medications within previous 7 days (excluding rewetting drops).
  • Moderate or severe corneal edema, corneal vascularization, corneal staining, injection, tarsal abnormalities, "other" complications, and any corneal infiltrates.
  • Current or history of ocular infection, severe inflammation, or disease within previous 6 months.
  • Any systemic disease that may affect the eye or be exacerbated by use of contact lenses or contact lens solutions.
  • Ocular or intra-ocular surgery within the previous 12 months (excluding placement of punctal plugs).
  • Use of medications contributing to dry eye or ocular irritation unless on a stable dosing regimen for a minimum of 30 days prior to study entry and able to remain on stable regimen throughout the study.
  • Participation in any investigational clinical study within previous 30 days.
  • Other protocol-specified exclusion criteria may apply.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01635920). 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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