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

NCT05661851 | Completed Phase 2 Results FDA Drug

• 1 other identifier: CR-6502
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 8

Brief Summary

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.

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in Overall Quality of Vision From Baseline to 30-Day Follow-Up Using VAS Scores

  Baseline and 30-Day Follow-up

Study Arms (2)

Investigational product

EXPERIMENTAL

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

Control product

ACTIVE COMPARATOR

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

Interventions

Investigational Lubricating Eye Drop in a Novelia® bottle DRUG

Investigational Product

Investigational product

Blink® Tears eye Drops DRUG

Control Product

Control product

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Potential subjects must satisfy all of the following criteria to be enrolled in the study:
• Read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
• Appear able and willing to adhere to the instructions set forth in this clinical protocol.
• Be between 18 and 69 (inclusive) years of age at the time of screening.
• 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).
• Self-reported symptoms of ocular dryness and/or the use of artificial tears in the last 3 months.
• Subjects must be non-contact lens wearers.
• The best corrected, monocular, distance visual acuity must be 20/30 or better in each eye, either unaided or best corrected.

You may not qualify if:

• Potential subjects must satisfy all of the following criteria to be enrolled in the study:
• Be currently pregnant or lactating.
• Be diabetic.
• 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).
• 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.
• 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.
• Have participated in any pharmaceutical or medical device related clinical trial within 30 days prior to study enrollment.
• 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.
• 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).
• 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).
• 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).
• Have a history of strabismus or amblyopia.
• 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.).
• Have any significant corneal distortion due to previous contact lens wear, surgery, or pathology (At the discretion of the investigator).

Sponsors & Collaborators

• Johnson & Johnson Vision Care, Inc.: lead

Study Sites (8)

Vue Optical Boutique

Jacksonville, Florida, 32205, United States

Location

Stam & Associates Eye Care

Jacksonville, Florida, 32256, United States

Location

Kannarr Eye Care

Pittsburg, Kansas, 66762, United States

Location

Complete Eye Care of Medina

Medina, Minnesota, 55340, United States

Location

ProCare Vision Centers

Granville, Ohio, 43023, United States

Location

Total Eye Care

Memphis, Tennessee, 38119, United States

Location

Tyler Eye Associates

Tyler, Texas, 75703, United States

Location

Botetourt Eyecare, LLC

Salem, Virginia, 24153, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Results Point of Contact

• Title: Principal Research Optometrist
• Organization: Johnson & Johnson Vision Care, Inc. (JJVC)

njoshi30@its.jnj.com

(347) 903-5029

Study Officials

• Johnson & Johnson Vision Care, Inc. Clinical Trial

  Johnson & Johnson Vision Care, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2022
• First Posted: December 22, 2022
• Study Start: February 23, 2023
• Primary Completion: April 27, 2023
• Study Completion: April 27, 2023
• Last Updated: April 27, 2025
• Results First Posted: May 1, 2024

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share

Locations

US (8)