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OpenTrials
Completed

NCT Number: NCT01423773

Ocular Comfort and OCT Observation of Post Lens Clearance and Ocular Tissue Compression

The purpose of this study was to compare the fit and comfort of two types of contact lenses.

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Key information

Conditions

Ocular Comfort

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

McKnight Building, Bascom Palmer Eye Institute

Miami, Florida, 33136, United States

About this study

The relationship between ocular comfort and the Optical Coherence Tomography (OCT) measurements of post lens clearance and ocular tissue compression was studied.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Be of legal age of consent and sign Informed Consent document.
  • Normal binocularity.
  • Be able to wear soft contact lenses.
  • Willing to comply with the wear and study visit schedule.
  • Spherical contact lens prescription within 0.50 diopter of the available lens powers.
  • Spectacle cylinder less than or equal to 1.50 diopter.
  • Other protocol-defined inclusion criteria may apply.

Exclusion criteria

  • Eye injury or surgery within twelve weeks of enrollment.
  • Pre-existing ocular irritation that would preclude contact lens fitting.
  • Currently enrolled in any clinical trial.
  • Evidence of systemic or ocular abnormality, infection, or disease likely to affect successful wear of contact lenses or use of accessory solutions as determined by the investigator.
  • Other protocol-defined exclusion criteria may apply.

Treatment and study plan

Lotrafilcon A test contact lens

Device

Silicone hydrogel single vision, soft contact lens with alternate parameters

Lotrafilcon A control contact lens

Device

Silicone hydrogel single vision, soft contact lens

Other names: Night&Day

Ultra-High Resolution Optical Coherence Tomographer (OCT)

Device

Investigational, nonsignificant risk device for measuring post lens clearance and ocular tissue compression during contact lens wear

Primary outcomes

  1. Final Comfort

    Time frame: Day 2, Hour 10

    Comfort was assessed by the participant on a Visual Analog Scale of 0 to 100, where 0=Extremely Uncomfortable ("My eyes are in pain. I cannot tolerate my lenses") and 100=Extremely Comfortable ("My eyes feel GREAT, better than normal. I cannot feel my lenses").

Sponsors and collaborators

Lead sponsor

CIBA VISION

Industry

Collaborators

  • Bascom Palmer Eye Institute

Registry information

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Aug 26, 2011
Registry last updated
Jun 28, 2013

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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