Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 9:39 PM
Ignite Modification Date:
2025-12-24 @ 9:39 PM
NCT ID:
NCT04437732
Brief Summary:
In this study, you will wear an invesetigational contact lens, Apioc-P or Apioc-PT, the way you wear your current contact lenses for approximately one month (no more than 35 days).
Detailed Description:
Apioc-P and Apioc-PT is an investigational contact lens, which means it has not been approved by the U.S. Food and Drug Administration (FDA), although the contact lens material, called Definitive 74, is already approved and marketed for contact lenses that are similar to Apioc-P and Apioc-PT. In this study, participants will wear an Apioc-P and Apioc-PT contact lens the way they wear their current contact lenses for approximately one month (no more than 35 days).
Participation in this study will include a minimum of four study visits. The first will last up to 90 minutes, the second will last up to 45 minutes, the third will last up to 45 minutes, and the final visit will be up to 90 minutes. If the lens does not appear to be fitting properly at the second visit, then another lens will be ordered for participants and they will be asked to return for an additional visit for up to 45 minutes. Up to 60 subjects will participate in this study.
Study:
NCT04437732
Study Brief:
Protocol Section:
NCT04437732