Evaluation of Approved and Investigational Contact Lenses



Status:Completed
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:18 - 49
Updated:12/15/2018
Start Date:July 14, 2017
End Date:September 18, 2017

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This study is a randomized, 5-visit, partial subject masked, 2x3 bilateral crossover,
dispensing clinical trial. During the study, each test article will be worn in a daily wear
modality for at least 6 hours per day and 5 days per week for approximately 2 weeks each. The
subject will wear either the Test or Control article twice and the other study article once.
The primary objective of this study is to demonstrate that the Test lens works as well, if
not better compared to the Control lens with respect to CLUE (Contact Lens User Experience)
comfort, Slit Lamp findings, and Distance Monocular logMAR Visual Acuity. This study will
also aim to show acceptable lens fit for subjects wearing the Test lens.


Inclusion Criteria:

- Potential subjects must satisfy all of the following inclusion criteria to be enrolled
in the study:

1. The subject must read and sign the Informed Consent 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 age ≥18 and ≤49 years of age with signed informed
consent. Eligible presbyopes will be those that wear full distance contact lenses
in both eyes, then wear reading glasses over them.

4. The subject's optimal vertexed spherical equivalent distance correction must be
between -1.00 and - 6.00 Diopter (D).

5. The subject's refractive cylinder must be ≤ 1.00D in each eye.

6. The subject must have visual acuity best correctable to 20/25+3 or better for
each eye.

7. Subjects must own a wearable pair of spectacles.

8. The subject is a current spherical soft contact lens wearer (defined as a minimum
of 6 hours of Daily Wear per day, at least 5 days per week, for a minimum of 1
month prior to the study) and willing to wear the study lenses on a similar
basis.

9. Subjects must be able and willing to wear the study lenses at least 6 hours a
day, a minimum of 5 days per week

10. The subject must have normal eyes (i.e., no ocular medications or infections of
any type).

Exclusion Criteria:

- Potential subjects who meet any of the following criteria will be excluded from
participating in the study:

1. Currently pregnant or lactating (subjects who become pregnant during the study
will be discontinued).

2. Any systemic disease, autoimmune disease, or use of medication, which may
interfere with contact lens wear. This may include, but not be limited to,
diabetes, hyperthyroidism, recurrent herpes simplex/zoster, Sjögren's syndrome,
xerophthalmia, acne rosacea, Stevens-Johnson syndrome, and immunosuppressive
diseases or any infectious diseases (e.g. hepatitis, tuberculosis).

3. Use of any of the following medications within 1 week prior to enrollment: oral
retinoid isotretinoin (e.g. Accutane), oral tetracyclines, topical scopolamine,
oral (e.g., Chlor-Trimeton, and Benadryl) and ophthalmic antihistamines, oral
phenothiazines (e.g., Haldol, Mellaril, Thorazine, Elavil, Pamelor, Compazine),
oral and ophthalmic Beta-adrenergic blockers (e.g., Propranolol, Timolol, and
Practolol), systemic steroids, and any prescribed or over the counter (OTC)
ocular medication.

4. Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of
recurrent corneal erosions, aphakia, or moderate or above corneal distortion.

5. Any previous, or planned, ocular or intraocular surgery (e.g., radial keratotomy,
photorefractive keratectomy (PRK), LASIK, etc.).

6. Any Grade 3 or greater slit lamp findings (e.g.., edema, corneal
neovascularization, corneal staining, tarsal abnormalities, conjunctival
injection) on the FDA classification scale, any previous history or signs of a
contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or
round peripheral scar), or any other ocular abnormality that may contraindicate
contact lens wear.

7. Any known hypersensitivity or allergic reaction to Optifree®PureMoist®
multi-purpose care solution or Eye-Cept® rewetting drop solution

8. Any ocular infection, allergy or clinically significant ocular disease (e.g.
corneal edema, uveitis, severe keratoconjunctivitis sicca, ocular hypertension),
or ocular conditions (e.g. strabismus), which might interfere with the study.

9. Any corneal distortion resulting from previous hard or rigid gas permeable
contact lens wear.

10. Toric, extended wear, monovision or multi-focal contact lens correction.

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

12. Participation in clinical trials involving the Test lens within 3 months prior to
study enrollment.

13. History of binocular vision abnormality or strabismus.

14. Employee, relative or friends of employees of any ophthalmic company, or
investigational clinic (e.g., Investigator, Coordinator, Technician).
We found this trial at
5
sites
East Lansing, Michigan 48823
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6830 Normandy Boulevard
Jacksonville, Florida 32205
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Jacksonville, FL
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Jacksonville, Florida 32205
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Jacksonville, FL
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Pickens, South Carolina 29671
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Pickens, SC
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Salt Lake City, Utah 84106
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Salt Lake City, UT
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