Clinical Evaluation of Two Marketed Artificial Tears in Non-contact Lens Wearing Patients

NCT03466086 | Completed Phase 4 Results FDA Device

• 1 other identifier: CR-6013
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical study is a randomized, double-masked, cross-over, bilateral, 2 treatment x 2 period, dispensing 4-visit study with a 7-9 day washout period in between visits 2 and 3. The study will last approximately 3 months.

Conditions

Visual Acuity

Outcome Measures

Primary Outcomes (1)

• Ocular Comfort

  Ocular comfort was measured using the visual analogue scale of 0 to 100. Where 0 is extremely uncomfortable and 100 is extremely comfortable.

  1-Week Follow-up

Secondary Outcomes (1)

• Subjective Dryness Rating

  1-Week Follow-up

Study Arms (2)

Test/Control

EXPERIMENTAL

Subjects between the ages of 18-69 years of age will sequentially try the Test and Control eye drops in a random order

Device: Test Eye Drops; Device: Control Eye Drops

Control/Test

EXPERIMENTAL

Subjects between the ages of 18-69 years of age will sequentially try the Control and Test eye drops in a random order.

Device: Test Eye Drops; Device: Control Eye Drops

Interventions

Test Eye Drops DEVICE

blink® intensive TRIPLE ACTION 3 in 1 eye drops

Control/Test; Test/Control

Control Eye Drops DEVICE

Systane® BALANCE eye drops

Control/Test; Test/Control

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 have a DEQ-5 score of \>6 at either Visit 0 (pre-screen) and/or Visit 1 (screening).
• Subjects must achieve visual acuity of 20/30 (equivalent to 0.18 logMAR) 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).
• 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 14 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 Only Medicines (POM) 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)

The University of Manchester

Manchester, United Kingdom

Location

Results Point of Contact

• Title: Meredith Bishop, OD, MS, FAAO
• Organization: Johnson & Johnson Vision

MBishop4@its.jnj.com

904-443-1396

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2018
• First Posted: March 15, 2018
• Study Start: February 9, 2018
• Primary Completion: May 16, 2018
• Study Completion: May 16, 2018
• Last Updated: June 28, 2019
• Results First Posted: May 29, 2019

Record last verified: 2019-06

Locations

GB (1)