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

NCT03995355 | Completed Results

• 1 other identifier: CR-6328
• Study Type: interventional
• Target: 161
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Visual Acuity

Outcome Measures

Primary Outcomes (1)

• Change From Baseline Ocular Comfort (30-Day)

  Subjective overall ocular comfort was assessed at baseline, and at the 30-Day follow-up using a Visual Analogue Scale (VAS) ranging 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 report.

  Baseline and 30-Day Follow-up

Secondary Outcomes (5)

• Change From Baseline Ocular Comfort (7-Day)

  Baseline and 7-Day Follow-up

• Number of Subject Eyes That Reported Ocular Symptoms

  7-Day Follow-up and 30-Day Follow-up

• Number of Subject Eyes That Experience Grade 2 or Higher Corneal Staining

  7-Day Follow-up and 30-Day Follow-up

• Change From Baseline Ocular Vision (7-Day)

  Baseline and 7 Day-Day Follow-up

• Change From Baseline Ocular Vision (30-Day)

  Baseline and 30 Day Follow-up

Study Arms (2)

Test Eye Drops

EXPERIMENTAL

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

Device: 9618X investigational lipid eye drops

Control Eye Drops

ACTIVE COMPARATOR

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

Device: Blink® Tears

Interventions

9618X investigational lipid eye drops DEVICE

Test Eye Drops

Test Eye Drops

Blink® Tears DEVICE

Control Eye Drops

Control Eye Drops

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

You may not qualify if:

• Potential subjects who meet any of the following criteria will be excluded from participating in the study:
• Currently pregnant or breast-feeding.
• Diabetes.
• Any ocular or systemic allergies or disease which may interfere with the clinical trial (at the investigator's discretion).
• Any systemic disease, autoimmune disease, or use of medication which may interfere with the clinical trial (at the investigator's discretion).
• Any infectious diseases (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g. HIV), by self-report.
• 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.
• Any active ocular abnormalities/conditions that may interfere with the clinical trial (this includes, but not limited to, chalazia, recurrent styles, pterygium, infection, etc.).
• Any corneal distortion due to previous rigid gas permeable lens wear, surgery or pathology.
• History of any ocular or corneal surgery (e.g. RK, PRK, LASIK).
• Participation in any pharmaceutical or medical device related clinical trial within 30 days prior to study enrollment.
• History of binocular vision abnormality or strabismus.
• Habitual wearers of soft contact lenses in the past 1 month or rigid gas permeable lens within the past 3 months.
• 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).
• Employees of investigational clinic (investigator, coordinator, and technician, etc.) or family member of an employee of the clinical site by self-report.

Sponsors & Collaborators

• Johnson & Johnson Vision Care, Inc.: lead

Study Sites (1)

Premier Vision

Amarillo, Texas, 79119, United States

Location

Related Publications (1)

• Donnenfeld E, Coats J, Barbour K, Ryan R, Joshi NR, Periman LM. Efficacy and safety of a lipid-containing artificial tear compared with a non-lipid containing tear: a randomized clinical trial. BMC Ophthalmol. 2024 Oct 8;24(1):442. doi: 10.1186/s12886-024-03688-z.

  PMID: 39379885 DERIVED

Results Point of Contact

• Title: Meredith Bishop, OD, MS, FAAO - Sr. Principal Research Optometrist
• Organization: Johnson & Johnson Vision

MBishop4@its.jnj.com

1-800-843-2020

Publication Agreements

• PI is Sponsor Employee: Yes
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2019
• First Posted: June 24, 2019
• Study Start: June 26, 2019
• Primary Completion: September 20, 2019
• Study Completion: September 20, 2019
• Last Updated: July 3, 2023
• Results First Posted: November 14, 2022

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share

Locations

US (1)