Myopia Clinical Trial
Official title:
Evaluation of the Feasibility of Fitting of Apioc Contact Lenses in Adults
NCT number | NCT03688672 |
Other study ID # | LEN001 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 1, 2018 |
Est. completion date | October 31, 2020 |
Verified date | January 2022 |
Source | Lentechs, LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 50 |
Est. completion date | October 31, 2020 |
Est. primary completion date | October 31, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | The Ohio State University | Columbus | Ohio |
Lead Sponsor | Collaborator |
---|---|
Lentechs, LLC |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Vertical Movement of Contact Lens in Downgaze | Vertical movement of the contact lens relative to the eye in downgaze in millimeters. | After 15 minutes of on-eye settling | |
Secondary | Movement of contact lens with blink | Movement of contact lens in straight-ahead gaze with a blink in millimeters. | After 15 minutes of on-eye settling | |
Secondary | Visual Acuity | logMAR visual acuity at 40 cm through the contact lens with distance correction in trial frame over the Apioc contact lens. | After 15 minutes of on-eye settling | |
Secondary | Comfort questionnaire | Subjects will be asked to assess the comfort of each lens by marking an "X" on a line between 0 and 100. | After 15 minutes of on-eye settling |
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