Clinical Evaluation of Fitting Investigational Contact Lenses



Status:Completed
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:40 - 70
Updated:7/1/2018
Start Date:March 27, 2017
End Date:March 31, 2017

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This study is a non-randomized, open label, bilateral, non- dispensing clinical trial with
only one visit. The Eye Care Providers will be provided with a fitting guide and will
determine the initial study lens selection. Each subject will wear either the investigational
contact lenses or marketed contact lenses for approximately 30-90 minutes. This study aims to
evaluate the ECPs impression of the fitting guide for a novel multifocal lens and also their
success in fitting the lenses.


Inclusion Criteria:

1. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and
receive a fully executed copy of the form

2. The subject must appear able and willing to adhere to the instructions set forth in
this clinical protocol.

3. Healthy adult males or females that are at least 40 years of age and no more than 70
years of age.

4. The subject must either be wearing a presbyopic contact lens correction (e.g., reading
spectacles over contact lenses, multifocal or monovision contact lenses, etc.) or if
not respond positively to at least one symptom on the "Presbyopic Symptoms
Questionnaire".

5. The subject is a current soft spherical or toric contact lens wearer (defined as a
minimum of 6 hours of wear per day at least two days of the week for a minimum of 1
month prior to the study).

6. The subject's distance spherical equivalent or spherical component (if fit with a
toric lens) of their refraction must be in the range -1.25 D to -3.75 D in each eye.

7. The subject's refractive cylinder must be 0.00 D to -1.50 D in at least one eye and no
greater than -1.50 D in either eye.

8. The subject's refractive cylinder axis must be 90°±30° or 180°±30° in each eye.

9. The subject's ADD power must be in the range of +0.75 D to +2.50 D in each eye.

10. The subject must have best corrected visual acuity of 20/20-3 or better in each eye.

11. The subject must have a wearable pair of spectacles if required for their distance
vision.

Exclusion Criteria:

1. Ocular or systemic allergies or disease, or use of medication which might interfere
with contact lens wear.

2. Pregnancy or lactation.

3. Currently diagnosed with diabetes.

4. Infectious diseases (e.g. hepatitis, tuberculosis) or an immune-suppressive disease
(e.g. HIV).

5. Clinically significant (Grade 3 or 4) corneal edema, corneal vascularization, corneal
staining, tarsal abnormalities or bulbar injection, or any other corneal or ocular
abnormalities which would contraindicate contact lens wear.

6. Entropion, ectropion, extrusions, chalazia, recurrent styes, dry eye, glaucoma,
history of recurrent corneal erosions.

7. Any previous, or planned, ocular or intraocular surgery (e.g., radial keratotomy, PRK,
LASIK, lid procedures, cataract surgery, retinal surgery, etc.).

8. A history of amblyopia, strabismus or binocular vision abnormality.

9. Any ocular infection or inflammation.

10. Any ocular abnormality that may interfere with contact lens wear.

11. Use of any ocular medication, with the exception of rewetting drops.

12. History of herpetic keratitis.

13. Participation in any contact lens or lens care product clinical trial within 30 days
prior to study enrollment.

14. Employee of clinical site (e.g., Investigator, Coordinator, Technician)
We found this trial at
1
site
Jacksonville, Florida 32256
?
mi
from
Jacksonville, FL
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