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

Dry Eye Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05661851
• Other study ID #: CR-6502
• Status: Completed
• Phase: Phase 2
• Start date: February 23, 2023
• Est. completion date: April 27, 2023

Study information

• Verified date: April 2024
• Source: Johnson & Johnson Vision Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: April 27, 2023
• Est. primary completion date: April 27, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 69 Years

Eligibility

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).

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes

Intervention

Drug:
• Investigational Lubricating Eye Drop in a Novelia® bottle
Investigational Product
• Blink® Tears eye Drops
Control Product

Locations

Country	Name	City	State
United States	ProCare Vision Centers	Granville	Ohio
United States	Stam & Associates Eye Care	Jacksonville	Florida
United States	Vue Optical Boutique	Jacksonville	Florida
United States	Complete Eye Care of Medina	Medina	Minnesota
United States	Total Eye Care	Memphis	Tennessee
United States	Kannarr Eye Care	Pittsburg	Kansas
United States	Botetourt Eyecare, LLC	Salem	Virginia
United States	Tyler Eye Associates	Tyler	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Vision Care, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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