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Apioc Contact Lens Feasibility

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03688672
Recruitment Status : Recruiting
First Posted : September 28, 2018
Last Update Posted : May 28, 2019
Sponsor:
Information provided by (Responsible Party):
Lentechs, LLC

Tracking Information
First Submitted Date  ICMJE September 25, 2018
First Posted Date  ICMJE September 28, 2018
Last Update Posted Date May 28, 2019
Actual Study Start Date  ICMJE October 1, 2018
Estimated Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 5, 2018)
Vertical Movement of Contact Lens in Downgaze [ Time Frame: After 15 minutes of on-eye settling ]
Vertical movement of the contact lens relative to the eye in downgaze in millimeters.
Original Primary Outcome Measures  ICMJE
 (submitted: September 26, 2018)
Vertical Movement [ Time Frame: After 15 minutes of on-eye settling ]
Vertical movement of the contact lens relative to the eye in downgaze in millimeters.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 26, 2018)
  • Movement of contact lens with blink [ Time Frame: After 15 minutes of on-eye settling ]
    Movement of contact lens in straight-ahead gaze with a blink in millimeters.
  • Visual Acuity [ Time Frame: After 15 minutes of on-eye settling ]
    logMAR visual acuity at 40 cm through the contact lens with distance correction in trial frame over the Apioc contact lens.
  • Comfort questionnaire [ Time Frame: After 15 minutes of on-eye settling ]
    Subjects will be asked to assess the comfort of each lens by marking an "X" on a line between 0 and 100.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Apioc Contact Lens Feasibility
Official Title  ICMJE Evaluation of the Feasibility of Fitting of Apioc Contact Lenses in Adults
Brief Summary This clinical trial will document the feasibility of the Apioc lens design by assessing which lens shape parameters yield successful on-eye-fit and movement of the Apioc contact lens design and evaluate the subjectively-reported comfort of the Apioc contact lens design.
Detailed Description This is a one-site, non-dispensing clinical trial using the Apioc contact lens design. This soft contact lens study will determine the feasibility of this design by determining which parameters of the shape of the Apioc Contact Lens design will yield a successful fit across subjects. We will also determine the percentage of subjects who can be successfully fitted with the Apioc Contact Lens Design. Because the feasibility of the lens design may be dependent upon age, a total of 50 subjects (10 subjects each across 5 decades of life) will complete the study. The data will be collected in a single visit for most subjects. A few subjects may be asked to return for a second visit if additional contact lens parameters need to be ordered to achieve a successful fit. The key assessments for this study will be demonstration of feasibility of fit, documentation of movement in all gazes, including translation, and subjective reports of comfort. Subjects will only wear contact lenses while in the office.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Condition  ICMJE
  • Ametropia
  • Myopia
  • Hyperopia
  • Astigmatism
  • Presbyopia
Intervention  ICMJE Device: Apioc Contact Lens Design
Novel soft contact lens design.
Study Arms  ICMJE Apioc Lens
All subjects will wear the same, Apioc Contact Lens design.
Intervention: Device: Apioc Contact Lens Design
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 26, 2018)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2019
Estimated Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Thirty subjects will be at least 40 years of age and no more than 60 years of age. Ten subjects will be at least 18 years of age and no more than 29 years of age. Ten subjects will be at least 30 years of age and no more than 39 years of age.
  2. The subject must have ≤ 1.50 D of corneal astigmatism.
  3. The subject should have clear, healthy corneas.
  4. The subject should have a normal, healthy conjunctiva in both eyes.
  5. The subject should be free of active ocular disease. Refractive error and presbyopia are permitted.
  6. The subject must provide written informed consent.
  7. The subject must appear willing and able to adhere to the instructions set forth in this protocol.

Exclusion Criteria:

  1. No irregular corneal astigmatism is permitted.
  2. No pterygia or corneal scarring that would interfere with contact lens wear.
  3. No pinguecula or other conjunctival thickness abnormalities are permitted that would interfere with contact lens wear.
  4. The subject should not be using any ocular pharmaceutical treatments, including artificial tears in the two weeks prior to the examination.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Nidhi Satiani, OD, MS 614-340-3349 ext 1118 nsatiani@lentechs.com
Contact: Nidhi D Satiani, OD, MS nsatiani@lentechs.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03688672
Other Study ID Numbers  ICMJE LEN001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Lentechs, LLC
Study Sponsor  ICMJE Lentechs, LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Heidi Wagner, OD, MS Ohio State University
PRS Account Lentechs, LLC
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP