Contact Lens Insertion and Removal in a Senior Subject Demographic
Status: | Completed |
---|---|
Conditions: | Ocular |
Therapuetic Areas: | Ophthalmology |
Healthy: | No |
Age Range: | 60 - Any |
Updated: | 7/27/2018 |
Start Date: | June 29, 2018 |
End Date: | July 12, 2018 |
This will be a pilot, one-visit, open-label, non-dispensing study. Subjects will be given
instructions and then attempt to insert and remove a contact lens in each eye.
instructions and then attempt to insert and remove a contact lens in each eye.
Inclusion Criteria:
- Potential subjects must satisfy all of the following criteria to be enrolled in the
study:
1. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and
receive a fully executed copy of the form.
2. Appear able and willing to adhere to the instructions set forth in this clinical
protocol.
3. Must be at least 60 years of age at the time of screening.
4. The subject must have normal eyes (i.e., no ocular medications or infections of
any type).
5. The subject must have best corrected visual acuity (BCVA) of 20/30 or better in
each eye.
Exclusion Criteria:
- Potential subjects who meet any of the following criteria will be excluded from
participating in the study:
1. A habitual and adapted wearer of contact lenses (have worn a contact lens at
least one time in the past 5 years).
2. Currently pregnant or lactating (subjects who become pregnant during the study
will be discontinued).
3. Any systemic disease, autoimmune disease, or use of medication that may interfere
with contact lens wear.
4. Any ocular infection.
5. Any corneal distortion resulting from previous hard or rigid gas permeable
contact lens wear.
6. Participation in any contact lens or lens care product clinical trial within 14
days prior to study enrollment.
7. History of binocular vision abnormality or strabismus.
8. Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious
immunosuppressive disease (e.g., HIV, by self-report).
9. Suspicion of or recent history of alcohol or substance abuse.
10. History of serious mental illness.
11. History of seizures.
12. Employee of investigational clinic (e.g., Investigator, Coordinator, Technician)
We found this trial at
1
site
Click here to add this to my saved trials