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Apioc Toric/Spherical Single Vision Contact Lens

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ClinicalTrials.gov Identifier: NCT03970512
Recruitment Status : Recruiting
First Posted : May 31, 2019
Last Update Posted : June 12, 2019
Sponsor:
Information provided by (Responsible Party):
Lentechs, LLC

Study Description
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Brief Summary:
The Lentechs Apioc-S and Apioc-A contact lenses are made in an FDA-approved contact lens material indicated for single-vision and astigmatism. The novel lens design has a lenticular portion which is thicker than the optical portion of the lens. When applied to the eye, it is oriented in a superior position. Unlike contact lenses currently on the market, this innovative design improves lens stability by preventing lens rotation, and may improve tear flow behind the lens.

Condition or disease Intervention/treatment Phase
Refractive Errors Device: Apioc-A and Apioc-S Contact Lenses Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 30 Day Fitting of a New Toric Contact Lens
Actual Study Start Date : May 31, 2019
Estimated Primary Completion Date : October 30, 2019
Estimated Study Completion Date : October 30, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Intervention Details:
  • Device: Apioc-A and Apioc-S Contact Lenses
    Appropriately fit, document and dispense a new spherical and toric contact lens design worn for up to 35 days.

Outcome Measures
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Primary Outcome Measures :
  1. Visual Acuity [ Time Frame: 30 days ]
    LogMAR distance visual acuity


Secondary Outcome Measures :
  1. Comfort [ Time Frame: 30 days ]
    Contact Lens Dry Eye Questionnaire-8, scale range 0 minimum (better outcome) to 38 maximum (worse outcome).

  2. Rotational Stability of Apioc-A [ Time Frame: 30 days ]
    Clockwise or counter-clockwise rotation


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. The subject must provide written informed consent.
  2. The subject must appear willing and able to adhere to the instructions set forth in this protocol.
  3. At least 18 years of age and no more than 35 years of age.
  4. ≤ 4.00 D of corneal astigmatism.
  5. ≤ 4.00 D of refractive astigmatism.
  6. Refractive error range +20.00 DS to -20.00 DS
  7. Flat and steep keratometry readings within 40 to 50D.
  8. Clear, healthy corneas with no irregular astigmatism.
  9. Normal, healthy conjunctiva in both eyes.
  10. Free of active ocular disease. Refractive error is permitted.
  11. Be a current or former (within the last 12 months) contact lens wearer.
  12. Best-corrected near and distance visual acuity better than or equal to 20/25.

Exclusion Criteria:

  1. Irregular corneal astigmatism.
  2. Presbyopia
  3. Corneal scarring unless off line-of-site and well healed.
  4. Pinguecula, pterygium, or other conjunctival thickness abnormalities that would interfere with soft contact lens wear.
  5. Recent use of any ocular pharmaceutical treatments, including daily artificial tears, in the two weeks prior to the examination. Use of artificial tears less than 3 drops per week is permitted.
  6. Systemic disease that would interfere with contact lens wear.
  7. Currently pregnant or lactating (by self-report).
  8. History of strabismus or eye movement disorder.
  9. Active allergies that may inhibit contact lens wear.
  10. Upper eyelid margin at or above the superior limbus.
  11. History of ocular or lid surgery.
Contacts and Locations
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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): NCT03970512


Contacts
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Contact: Melissa D Bailey, OD, PhD 614-453-9586 mbailey@lentechs.com

Locations
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United States, Ohio
Quinn Foster & Associates Recruiting
Athens, Ohio, United States, 45701
Contact: Dana Gillum    740-594-2271      
EyeCare Professionals of Powell Recruiting
Powell, Ohio, United States, 43065
Contact: Jason Smith    614-793-0700      
Sponsors and Collaborators
Lentechs, LLC
Investigators
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Principal Investigator: Thomas G Quinn, OD, MS, FAAO Drs. Quinn, Foster & Associates
Principal Investigator: Jason R Miller, OD, MBA Eyecare Professionals of Powell
More Information
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Responsible Party: Lentechs, LLC
ClinicalTrials.gov Identifier: NCT03970512     History of Changes
Other Study ID Numbers: LEN004
First Posted: May 31, 2019    Key Record Dates
Last Update Posted: June 12, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Lentechs, LLC:
contact lens
soft contact lens
Additional relevant MeSH terms:
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Refractive Errors
Eye Diseases