Clinical Evaluation of a Multidose Preservative-free Lubricating Eye Drops Contained in Novelia® Eye Dropper 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

Clinical Phase

PHASE2

Total Enrollment

121 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-23

Study Completion Date

2023-04-27

Brief Summary

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This is a 30-Day, multi-site, single-masked, bilateral, active- controlled, 2-Arm parallel group study to evaluate the safety and efficacy of an Investigational product.

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Detailed Description

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Conditions

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Dry Eye

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Investigational product

Eligible subjects will be randomly assigned the investigational product to be used in both eyes for the duration of the study.

Group Type EXPERIMENTAL

Investigational Lubricating Eye Drop in a Novelia® bottle

Intervention Type DRUG

Investigational Product

Control product

Eligible subjects will be randomly assigned the control product to be used in both eyes for the duration of the study

Group Type ACTIVE_COMPARATOR

Blink® Tears eye Drops

Intervention Type DRUG

Control Product

Interventions

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Investigational Lubricating Eye Drop in a Novelia® bottle

Investigational Product

Intervention Type DRUG

Blink® Tears eye Drops

Control Product

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

1. 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. Be between 18 and 69 (inclusive) years of age at the time of screening.
4. Possess a wearable pair of spectacles that provide correction for distance vision and bring them to every visit (only if applicable- to the investigator's discretion).
5. Self-reported symptoms of ocular dryness and/or the use of artificial tears in the last 3 months.
6. Subjects must be non-contact lens wearers.
7. The best corrected, monocular, distance visual acuity must be 20/30 or better in each eye, either unaided or best corrected.

Exclusion Criteria

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

1. Be currently pregnant or lactating.
2. Be diabetic.
3. Be currently using any ocular medications or have any ocular infection of any type which may interfere with the clinical trial (at the investigator's discretion).
4. By self-report, have any ocular or systemic disease, allergies, infection, or use of medication that might contraindicate or interfere with the clinical trial, or otherwise compromise study endpoints, including infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive disease (e.g., Human Immunodeficiency Virus \[HIV\]), autoimmune disease (e.g., rheumatoid arthritis, Sjögren's syndrome), or history of serious mental illness or seizures. See section 9.1 for additional details regarding excluded systemic medications.
5. Have habitually worn rigid gas permeable (RGP) lenses, orthokeratology lenses, or hybrid lenses (e.g., SynergEyes, SoftPerm) within the past 3 months and soft contact lenses in the past 1 month.
6. Have participated in any pharmaceutical or medical device related clinical trial within 30 days prior to study enrollment.
7. Be an employee (e.g., Investigator, Coordinator, Technician) or immediate family member of an employee (including partner, child, parent, grandparent, grandchild or sibling of the employee or their spouse) of the clinical site.
8. Be a current habitual user of prescription medication to treat dry eye and ocular discomfort, ocular steroids, or any medication (RX or OTC), except for artificial tears that would interfere with the clinical study (at the discretion of the investigator).
9. Have any known allergy or sensitivity to ingredients that the investigational product may contain (e.g., Sodium Chlorite, Boric Acid, Sodium Borate Decahydrate, Sodium Chloride, Potassium Chloride, Calcium Chloride Dihydrate, Magnesium Chloride Hexahydrate, Polyethylene Glycol 400, Sodium Hyaluronate and Purified Water).
10. Have clinically significant (grade 3 or higher on the FDA grading scale) slit lamp findings (e.g., corneal edema, neovascularization or staining, tarsal abnormalities, or bulbar injection) or other corneal or ocular disease or abnormalities that contraindicate participation or may otherwise compromise study endpoints (including entropion, ectropion, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, moderate or above corneal distortion, herpetic keratitis).
11. Have a history of strabismus or amblyopia.
12. Have had or have planned (within the study period) any ocular or intraocular surgery (e.g., radial keratotomy, PRK, LASIK, iridotomy, cataract removal, retinal laser photocoagulation, etc.).
13. Have any significant corneal distortion due to previous contact lens wear, surgery, or pathology (At the discretion of the investigator).

Minimum Eligible Age

18 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes