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
|Condition or disease||Intervention/treatment||Phase|
|Ametropia Myopia Hyperopia Astigmatism Presbyopia||Device: Apioc Contact Lens Design||Not Applicable|
|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|
All subjects will wear the same, Apioc Contact Lens design.
Device: Apioc Contact Lens Design
Novel soft contact lens design.
- 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.
- 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.
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
|Contact: Nidhi Satiani, OD, MS||614-340-3349 ext firstname.lastname@example.org|
|Contact: Nidhi D Satiani, OD, MSemail@example.com|
|United States, Ohio|
|The Ohio State University||Recruiting|
|Columbus, Ohio, United States, 43230|
|Contact: Heidi Wagner, OD, MPH|
|Principal Investigator:||Heidi Wagner, OD, MS||Ohio State University|