Clinical Evaluation of an Investigational Lipid Drop in Non-contact Lens Wearing Patients

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

161 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-26

Study Completion Date

2019-09-20

Brief Summary

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This is a double-masked, randomized, bilateral, 2-Arm parallel group study. Subjects are scheduled for 3 study visits (screening/baseline, 7-Day and 30-Day follow-up visits) over a period of one month.

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Detailed Description

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Conditions

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Visual Acuity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Test Eye Drops

Eligible subjects that are non-contact lens wearers will be randomized to the Test group throughout the duration of the study.

Group Type EXPERIMENTAL

9618X investigational lipid eye drops

Intervention Type DEVICE

Test Eye Drops

Control Eye Drops

Eligible subjects that are non-contact lens wearers will be randomized to the Control group throughout the duration of the study.

Group Type ACTIVE_COMPARATOR

Blink® Tears

Intervention Type DEVICE

Control Eye Drops

Interventions

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9618X investigational lipid eye drops

Test Eye Drops

Intervention Type DEVICE

Blink® Tears

Control Eye Drops

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Potential subjects must satisfy all the following criteria to be enrolled in the study:

1. Subjects must be at least 18 years of age and no more than 69 years of age (inclusive).
2. Subjects must be non-contact lens wearers.
3. Subjects must achieve visual acuity of 20/30 or better in each eye, either unaided or best corrected.
4. Subjects must possess a functional/usable pair of spectacles and bring them to every visit (only if applicable - to the investigators discretion).
5. Self-reported symptoms of ocular dryness or irritation and/or the use of artificial tears in the last 3 months.
6. Subjects must read, understand, and sign the Statement of Informed Consent.
7. Subjects must appear able and willing to adhere to the instructions set forth in this clinical protocol.

Exclusion Criteria

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

1. Currently pregnant or breast-feeding.
2. Diabetes.
3. Any ocular or systemic allergies or disease which may interfere with the clinical trial (at the investigator's discretion).
4. Any systemic disease, autoimmune disease, or use of medication which may interfere with the clinical trial (at the investigator's discretion).
5. Any infectious diseases (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g. HIV), by self-report.
6. Any Grade 3 or greater biomicroscopy findings (this includes, corneal edema, corneal staining, corneal vascularization, conjunctival injection, tarsal abnormalities, bulbar injection) on the FDA scale.
7. Any active ocular abnormalities/conditions that may interfere with the clinical trial (this includes, but not limited to, chalazia, recurrent styles, pterygium, infection, etc.).
8. Any corneal distortion due to previous rigid gas permeable lens wear, surgery or pathology.
9. History of any ocular or corneal surgery (e.g. RK, PRK, LASIK).
10. Participation in any pharmaceutical or medical device related clinical trial within 30 days prior to study enrollment.
11. History of binocular vision abnormality or strabismus.
12. Habitual wearers of soft contact lenses in the past 1 month or rigid gas permeable lens within the past 3 months.
13. Current habitual use of Prescription Medicines to treat dry eye or ocular discomfort, ocular steroids, or any medication (RX or OTC) that would interfere with the clinical study (at the discretion of the investigator).
14. Employees of investigational clinic (investigator, coordinator, and technician, etc.) or family member of an employee of the clinical site by self-report.

In addition to the above criteria, patients with any allergy or sensitivity to ingredients that this product may contain (Castor Oil, Polyoxyl 40 Hydrogenated Castor Oil, Sodium Chlorite, Boric Acid, Sodium Borate Decahydrate, Sodium Chloride, Potassium Chloride, Calcium Chloride Dihydrate, Magnesium Chloride Hexahydrate, Polyethylene Glycol 400, Sodium Hyaluronate, Purified Water) should not participate in the study.

Minimum Eligible Age

18 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes