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Corneal Oxygen Uptake With Apioc Contact Lenses

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04031118
Recruitment Status : Enrolling by invitation
First Posted : July 24, 2019
Last Update Posted : July 24, 2019
Sponsor:
Information provided by (Responsible Party):
Lentechs, LLC

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

Condition or disease Intervention/treatment Phase
Contact Lens-Induced Corneal Disorder of Both Eyes (Diagnosis) Device: Apioc Contact Lens Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Device Feasibility
Official Title: Corneal Oxygen Uptake With Apioc Contact Lenses
Actual Study Start Date : July 15, 2019
Estimated Primary Completion Date : October 31, 2019
Estimated Study Completion Date : October 31, 2019

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: Apioc Contact Lens
    Measurement of corneal oxygen uptake with contact lens wear.


Primary Outcome Measures :
  1. Corneal Oxygen Uptake Rate [ Time Frame: up to 45 seconds ]
    uptake of oxygen by human cornea in vivo



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04031118


Locations
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United States, Ohio
Rev1 Ventures
Columbus, Ohio, United States, 43212
Sponsors and Collaborators
Lentechs, LLC
  Study Documents (Full-Text)

Documents provided by Lentechs, LLC:

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Responsible Party: Lentechs, LLC
ClinicalTrials.gov Identifier: NCT04031118    
Other Study ID Numbers: Len-003
First Posted: July 24, 2019    Key Record Dates
Last Update Posted: July 24, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Corneal Diseases
Eye Diseases