Evaluation of Astigmatic Contact Lenses



Status:Completed
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:18 - 40
Updated:7/12/2018
Start Date:March 1, 2017
End Date:May 4, 2017

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Randomized, double-masked, 5-visit, bilateral dispensing, parallel group study to demonstrate
that the investigational contact lens meets the design requirements related to corneal
staining, lens fit, visual acuity and rotational performance as well as subjective comfort
and handling. Subjects will wear the contact lenses for a total of 28-36 days.


Inclusion Criteria:

- 1) Healthy adult males or females age ≥18-40 years of age with signed informed
consent.

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

3) Subject must be a habitual soft toric contact lens wearer. Habitual wearer is
defined as someone who wears contact lenses for at least 6 hours a day, 5 days a week
for the past 30 days.

4) Subject's vertex corrected spherical component of their distance refraction must be
between -1.00 to -4.75 Diopter (D) (inclusive) in each eye.

5) Subject's vertex corrected refractive cylinder must be between -0.75 and -1.50 DC
(inclusive) in each eye.

6) Subject's refractive cylinder axis must be 180±25 and 90±15 in each eye. 7) The
subject must have visual acuity best correctable to 20/25 or better for each eye 8)
The subject must read and sign the Informed Consent form.

Exclusion Criteria:

- 1) Women who are pregnant or breastfeeding, 2) Any ocular or systemic allergies or
diseases that may contraindicate contact lens wear.

3) Any ocular medications use within the last one month. 4) Any systemic disease,
autoimmune disease, or use of medication, which may interfere with contact lens wear.

5) Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious
immunosuppressive disease (e.g., HIV), by self-report.

6) Habitual wearer of extended wear contact lenses. 7) Known sensitivity to Revitalens
OcuTec® 8) Any previous history of ocular and/or refractive surgery (e.g., radial
keratotomy, PRK, LASIK, etc.).

9) A clinical finding or history of entropion, ectropion, extrusions, chalazia,
recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate
or above corneal distortion, by self-report.

10) History of binocular vision abnormality or strabismus, by self-report. 11)
Habitual wearer of rigid gas permeable (RGP) lenses, orthokeratology lenses, or hybrid
lenses (e.g. SynergEyes, SoftPerm) within the past 6 months.

12) Employee of investigational clinic (e.g., Investigator, Coordinator, Technician).

13) Participation in any contact lens or lens care product clinical trial within 14
days prior to study enrollment.

14) Clinically significant (grade 3 or higher) corneal edema, corneal vascularization,
corneal staining, tarsal abnormalities, bulbar injection or any other abnormalities
which would contraindicate contact lens wear.

15) Any history of a contact lens-related corneal inflammatory event within the past
year that may contraindicate contact lens wear.

16) Any active ocular infection. 17) Any corneal distortion resulting from previous
hard or rigid gas permeable contact lens wear.

18) Any fluctuations in vision due to clinically significant dry eye or other ocular
conditions.
We found this trial at
17
sites
5341 Wyoming Boulevard Northeast
Albuquerque, New Mexico 87109
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Albuquerque, NM
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Amarillo, Texas 79119
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Amarillo, TX
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Bloomington, Indiana 47405
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Bloomington, IN
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1955 Newark Granville Road
Granville, Ohio 43023
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Granville, OH
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6830 Normandy Boulevard
Jacksonville, Florida 32205
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Jacksonville, FL
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Jacksonville Beach, Florida 32250
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Jacksonville Beach, FL
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105 East Lake Brantley Drive
Longwood, Florida 32779
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Longwood, FL
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600 South Orlando Avenue
Maitland, Florida 32751
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Maitland, FL
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Memphis, Tennessee
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Memphis, TN
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Pittsburg, Kansas 66762
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Pittsburg, KS
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9711 Sawmill Parkway
Powell, Ohio 43065
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Powell, OH
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70 Summerfield Court
Salem, Virginia 24153
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Salem, VA
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2319 Highland Drive
Salt Lake City, Utah 84106
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Salt Lake City, UT
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Vestal, New York 13850
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Vestal, NY
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222 Jefferson Boulevard
Warwick, Rhode Island 02888
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Warwick, RI
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Westerville, Ohio 43081
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Westerville, OH
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Whittier, California 90606
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Whittier, CA
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