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OpenTrials
Completed

NCT Number: NCT02258139

Study to Evaluate the Product Performance of a New Silicone Hydrogel Contact Lens

This will be a randomized non-dispensing study comparing the overnight corneal swelling of an eye while wearing no contact lens to the Ultra contract lens.

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Key information

Conditions

Corneal Deformity

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Indiana University

Bloomington, Indiana, 47405, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Be between 18 and 40 years of age (inclusive)
  • Not a current contact lens wearer (have not worn extended wear, and not worn in lenses in 6 months)
  • Able to read, comprehend and sign an informed consent
  • Willing to comply with the wear and study visit schedule
  • Monocular best-corrected distance visual acuity >/-20/25 in each eye

Exclusion criteria

  • Any active corneal infection, disease, injury, inflammation, past surgery, or ocular abnormality which may interfere with contact lens wear
  • Systemic or ocular allergies, which might interfere with contact lens wear
  • Systemic disease or condition, which might interfere with contact lens wear
  • Use of prescription sleep aids or alcohol within 24 hours of study appointment
  • Inability to wear contact lenses
  • Under 18 years of age

Treatment and study plan

B&L Investigational Contact Lens

Device

The lens used in this study will be supplied by the Sponsor. All subjects will wear a -3.00D lens.

Primary outcomes

  1. Percent Change in Central Corneal Thickness

    Time frame: 8 hours

    Percent change in central corneal thickness from evening to morning (after 8 hours with lid closed)

Secondary outcomes

  1. Time to Restore Central Corneal Thickness

    Time frame: 48 hours

    Time (hours) to restore central corneal thickness to its baseline value after lens removal

Sponsors and collaborators

Lead sponsor

Bausch & Lomb Incorporated

Industry

Registry information

Official study title

The Study to Evaluate the Product Performance of a New Silicone Hydrogel Contact Lens

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Oct 7, 2014
Registry last updated
Sep 14, 2020

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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