Clinical Evaluation of a Multidose Preservative-free Lubricating Eye Drops Contained in Novelia® Eye Dropper in Non-Contact Lens Wearing Patients

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.

Study Overview

• Status: Completed
• Conditions: Dry Eye
• Intervention / Treatment: Drug: Investigational Lubricating Eye Drop in a Novelia® bottle; Drug: Blink® Tears eye Drops

• Study Type: Interventional
• Enrollment (Actual): 121
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32205
      • Vue Optical Boutique
    • Jacksonville, Florida, United States, 32256
      • Stam & Associates Eye Care
  • Kansas
    • Pittsburg, Kansas, United States, 66762
      • Kannarr Eye Care
  • Minnesota
    • Medina, Minnesota, United States, 55340
      • Complete Eye Care of Medina
  • Ohio
    • Granville, Ohio, United States, 43023
      • Procare Vision Centers
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Total Eye Care
  • Texas
    • Tyler, Texas, United States, 75703
      • Tyler Eye Associates
  • Virginia
    • Salem, Virginia, United States, 24153
      • Botetourt Eyecare, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Investigational product; Eligible subjects will be randomly assigned the investigational product to be used in both eyes for the duration of the study.	Drug: Investigational Lubricating Eye Drop in a Novelia® bottle; Investigational Product
Active Comparator: Control product; Eligible subjects will be randomly assigned the control product to be used in both eyes for the duration of the study	Drug: Blink® Tears eye Drops; Control Product

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Overall Quality of Ocular Comfort From Baseline to 30-Day Follow-Up Using VAS Scores	Subjective ocular comfort was assessed at baseline, and at 30-day follow-up using a Visual Analogue Scale (VAS) with continuous scale from 0 (extremely uncomfortable) to 100 (extremely comfortable). The change from baseline ocular comfort score was calculated as 30-day follow-up score minus baseline score. Change from baseline VAS scores range from -100 to 100, where higher change from baseline comfort scores indicates better performance. The average change from baseline comfort score for each Arm was reported.	Baseline and 30-Day Follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Overall Quality of Vision From Baseline to 30-Day Follow-Up Using VAS Scores	Subjective vision was assessed at baseline, and at 30-day follow-up using a Visual Analogue Scale (VAS) with continuous scale from 0 (extremely uncomfortable) to 100 (extremely comfortable). The change from baseline quality of vision score was calculated as 30-day follow-up score minus baseline score. Change from baseline VAS scores range from -100 to 100, where higher change from baseline vision scores indicates better performance. The average change from baseline vision score for each arm was report.	Baseline and 30-Day Follow-up

Collaborators and Investigators

• Sponsor: Johnson & Johnson Vision Care, Inc.
• Investigators: Study Director: Johnson & Johnson Vision Care, Inc. Clinical Trial, Johnson & Johnson Vision Care, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2023
• Primary Completion (Actual): April 27, 2023
• Study Completion (Actual): April 27, 2023

Study Registration Dates

• First Submitted: December 14, 2022
• First Submitted That Met QC Criteria: December 14, 2022
• First Posted (Actual): December 22, 2022

Study Record Updates

• Last Update Posted (Actual): April 27, 2025
• Last Update Submitted That Met QC Criteria: April 24, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Dry Eye Syndromes; Pharmaceutical Solutions; Lubricant Eye Drops; Ophthalmic Solutions
• Other Study ID Numbers: CR-6502

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Johnson & Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No