The Ocular Coil Drug delivery Comfort (OCDC) trial
Completed
- Conditions
- niet van toepassing10015919
- Registration Number
- NL-OMON47468
- Lead Sponsor
- Oogheelkunde
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
Inclusion Criteria
* Age between 18 and 75 years old
* Informed and having given informed consent
* Willing and able to comply with scheduled visits and other study procedures
* If wearing contact lenses, willing to replace them for glasses for the duration of the study
Exclusion Criteria
* Subjects with a history of eye disease
* Subjects using eye drops (during the study).
* Subjects with an Oriental/Asian lid crease, because of their narrow fornix.
* Subjects who do not speak and/or write Dutch properly.
* Subjects with a history of serious adverse reaction or hypersensitivity
- Subjects with hay fever
* Women who are pregnant or nursing their child, or have the intention to become pregnant during the course of the study.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary objective is the evaluation of the safety of the ocular coil. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary objectives are coil retention (duration), subject comfort (tolerance)<br /><br>and incidence of adverse effects and complications. </p><br>