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OpenTrials
Completed

NCT Number: NCT04031118

Corneal Oxygen Uptake With Apioc Contact Lenses

The purpose of this research is to determine if a new investigational contact lens shape allows the eye to get more oxygen.

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Key information

Conditions

Contact Lens-Induced Corneal Disorder of Both Eyes (Diagnosis) Disease Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rev1 Ventures

Columbus, Ohio, 43212, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Provide informed consent.
  • Appear willing and able to adhere to instructions set forth in the protocol.
  • Be between the ages of 18 and 45.
  • Be an experienced contact lens wearer.
  • Be an eyecare clinician or clinician-in-training.
  • Flat and steep keratometry readings within 40 to 50D.
  • Clear, healthy corneas with no irregular astigmatism.
  • Normal, healthy conjunctiva in both eyes.
  • Be able to provide corneal topography measurements.
  • Be able to provide manifest refraction measurements.

Exclusion criteria

  • Irregular corneal astigmatism.
  • Use of topical or systemic antihistamines within the previous week.
  • Use of topical ophthalmic drops within the previous two days.
  • History of corneal surgery.
  • Currently pregnant or lactating.
  • Systemic disease that would interfere with contact lens wear.
  • Previous diagnosis of dry eye syndrome.

Treatment and study plan

Apioc Contact Lens

Device

Measurement of corneal oxygen uptake with contact lens wear.

Primary outcomes

  1. Corneal Oxygen Uptake Rate

    Time frame: up to 45 seconds

    uptake of oxygen by human cornea in vivo

Sponsors and collaborators

Lead sponsor

Lentechs, LLC

Industry

Registry information

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jul 24, 2019
Registry last updated
Oct 10, 2023

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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