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Corneal Oxygen Uptake With Apioc Contact Lenses

L

Lentechs

Status

Completed

Conditions

Contact Lens-Induced Corneal Disorder of Both Eyes (Diagnosis)

Treatments

Device: Apioc Contact Lens

Study type

Interventional

Funder types

Industry

Identifiers

NCT04031118
Len-003

Details and patient eligibility

About

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

Enrollment

20 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Device Feasibility

Allocation

N/A

Interventional model

Single Group Assignment

Masking

Single Blind

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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