Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 27, 2019
Sponsor:
Information provided by (Responsible Party):
Lentechs, LLC

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.

Condition or disease Intervention/treatment Phase
Ametropia Myopia Hyperopia Astigmatism Presbyopia Device: Apioc Contact Lens Design Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Evaluation of the Feasibility of Fitting of Apioc Contact Lenses in Adults
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Arm Intervention/treatment
Apioc Lens
All subjects will wear the same, Apioc Contact Lens design.
Device: Apioc Contact Lens Design
Novel soft contact lens design.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

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): NCT03688672


Contacts
Layout table for location contacts
Contact: Nidhi Satiani, OD, MS 614-340-3349 ext 1118 nsatiani@lentechs.com
Contact: Nidhi D Satiani, OD, MS nsatiani@lentechs.com

Locations
Layout table for location information
United States, Ohio
The Ohio State University Recruiting
Columbus, Ohio, United States, 43230
Contact: Heidi Wagner, OD, MPH         
Sponsors and Collaborators
Lentechs, LLC
Investigators
Layout table for investigator information
Principal Investigator: Heidi Wagner, OD, MS Ohio State University

Layout table for additonal information
Responsible Party: Lentechs, LLC
ClinicalTrials.gov Identifier: NCT03688672     History of Changes
Other Study ID Numbers: LEN001
First Posted: September 28, 2018    Key Record Dates
Last Update Posted: May 27, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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.: Yes
Keywords provided by Lentechs, LLC:
contact lens
soft contact lens
feasibility
Additional relevant MeSH terms:
Layout table for MeSH terms
Astigmatism
Presbyopia
Hyperopia
Refractive Errors
Eye Diseases