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OpenTrials
Completed

NCT Number: NCT01629693

Clinical Evaluation of Two Monthly Replacement Silicone Hydrogel Contact Lenses

The purpose of this study is to evaluate differences in the comfort at the end of the month between Air Optix® lenses versus Biofinity® lenses in habitual daily wear symptomatic soft contact lens wearers.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Must sign written informed consent document.
  • Currently wearing weekly/biweekly or monthly sphere or toric soft contact lenses (NOT including AIR OPTIX Aqua, AIR OPTIX NIGHT & DAY Aqua, AIR OPTIX for Astigmatism, Biofinity Sphere, Biofinity Toric, or ProClear Toric soft contact lenses) bilaterrally (in both eyes) and have worn these lenses for at least 3 months, daily wear use only (no extended wear).
  • Symptomatic for contact lens-related ocular discomfort at the end of the lens wearing day.
  • Current contact lens prescription within the available parameters of both study products.
  • Able to achieve visual acuity (VA) of at least 6/7.5 (20/25) in each eye with study lenses in the available parameters.
  • Willing to wear study lenses for at least 4 hours/day and at least 5 days/week for the 1 month trial period.
  • Willing and able to follow instructions, study procedures and maintain the appointment schedule.
  • Other protocol-defined inclusion criteria may apply.

Exclusion criteria

  • Neophytes and current wearers of AIR OPTIX Aqua, AIR OPTIX NIGHT & DAY Aqua, AIR OPTIX for Astigmatism, Biofinity sphere, Biofinity Toric, or ProClear Toric soft contact lenses.
  • Any systemic or ocular disease or disorder (refractive disorder allowed and dry eye is permitted), complicating factors or structural abnormality that would negatively affect the conduct or outcome of the study.
  • Recent (within 7 days of enrollment) or current ocular infections, active ocular inflammation, glaucoma or preauricular lymphadenopathy.
  • A history of ocular surgery/trauma within the last 6 months.
  • Topical or systemic antibiotics use within 7 days of enrollment.
  • Topical ocular or systemic corticosteroids use within 14 days of enrollment.
  • Participation in any other ophthalmic drug or device clinical trial within 30 days of enrollment.
  • Other protocol-defined exclusion criteria may apply.

Treatment and study plan

Lotrafilcon B contact lenses

Device

Silicone hydrogel contact lenses (sphere or toric) per subject's habitual prescription

Other names: AIR OPTIX® AQUA, AIR OPTIX® for ASTIGMATISM

Comfilcon A contact lenses

Device

Silicone hydrogel contact lenses (sphere or toric) per subject's habitual prescription

Other names: Biofinity® Sphere, Biofinity® Toric

Primary outcomes

  1. Change From Baseline in Likert Response: "I Can Comfortably Wear my Lenses" at Day 30

    Time frame: Baseline, Day 30

    Overall comfort was assessed by the participant as a response to the questionnaire item 'I can comfortably wear my lenses', using a 10-point Likert scale, with 1=poor and 10=excellent.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jun 28, 2012
Registry last updated
Nov 6, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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