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

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.

Study Overview

• Status: Completed
• Conditions: Visual Acuity
• Intervention / Treatment: Device: Test Eye Drops; Device: Control Eye Drops

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Phase 4

Contacts and Locations

Study Locations

• United Kingdom
  • Manchester, United Kingdom
    • The University of Manchester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 69 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Potential subjects must satisfy all the following criteria to be enrolled in the study:

  1. Subjects must be at least 18 years of age and no more than 69 years of age (inclusive)
  2. Subjects must be non-contact lens wearers
  3. Subjects must have a DEQ-5 score of >6 at either Visit 0 (pre-screen) and/or Visit 1 (screening).
  4. Subjects must achieve visual acuity of 20/30 (equivalent to 0.18 logMAR) or better in each eye, either unaided or best corrected.
  5. Subjects must possess a functional/usable pair of spectacles and bring them to every visit (only if applicable - to the investigators discretion).
  6. Subjects must read, understand, and sign the Statement of Informed Consent.

  7. Subjects must appear able and willing to adhere to the instructions set forth in this clinical protocol

     Exclusion Criteria:

• Potential subjects who meet any of the following criteria will be excluded from participating in the study:

  1. Currently pregnant or breast-feeding.
  2. Diabetes.
  3. Any ocular or systemic allergies or disease which may interfere with the clinical trial (at the investigator's discretion).
  4. Any systemic disease, autoimmune disease, or use of medication which may interfere with the clinical trial (at the investigator's discretion).
  5. Any infectious diseases (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g. HIV), by self-report
  6. 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
  7. Any active ocular abnormalities/conditions that may interfere with the clinical trial (this includes, but not limited to, chalazia, recurrent styles, pterygium, infection, etc)
  8. Any corneal distortion due to previous rigid gas permeable lens wear, surgery or pathology
  9. History of any ocular or corneal surgery (e.g. RK, PRK, LASIK)
  10. Participation in any pharmaceutical or medical device related clinical trial within 14 days prior to study enrollment.
  11. History of binocular vision abnormality or strabismus.
  12. Habitual wearers of soft contact lenses in the past 1 month or rigid gas permeable lens within the past 3 months
  13. 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).)
  14. Employees of investigational clinic (investigator, coordinator, and technician etc) or family member of an employee of the clinical site by self-report.

In addition to the above criteria, patients with any allergy or sensitivity to ingredients that this product may contain (liposomes, sodium hyaluronate, vitamin E polyethylene glycol succinate (TPGS), polyethylene glycol 400 (PEG 400), disodium edetate, polyhexanide methylbiguanide, propylene glycol, boric acid, dimyristoyl phosphatidylglycerol, edetate disodium, hydroxypropyl guar, mineral oil, polyoxyl 40 sterate, polyquaternium-1, sorbitan tristearate, sorbitol, hydrochloric acid and/or sodium hydroxide) should not participate in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Test/Control; 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; blink® intensive TRIPLE ACTION 3 in 1 eye drops; Device: Control Eye Drops; Systane® BALANCE eye drops
EXPERIMENTAL: Control/Test; 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; blink® intensive TRIPLE ACTION 3 in 1 eye drops; Device: Control Eye Drops; Systane® BALANCE eye drops

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective Dryness Rating	Subjective dryness was assessed using Ocular Surface Disease Index (OSDI©) instrument. Dryness is evaluated on a scale of 0 to 100, where higher scores indicate more symptoms of dryness	1-Week Follow-up

Collaborators and Investigators

• Sponsor: Johnson & Johnson Vision Care, Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 9, 2018
• Primary Completion (ACTUAL): May 16, 2018
• Study Completion (ACTUAL): May 16, 2018

Study Registration Dates

• First Submitted: February 26, 2018
• First Submitted That Met QC Criteria: March 8, 2018
• First Posted (ACTUAL): March 15, 2018

Study Record Updates

• Last Update Posted (ACTUAL): June 28, 2019
• Last Update Submitted That Met QC Criteria: June 19, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pharmaceutical Solutions; Ophthalmic Solutions
• Other Study ID Numbers: CR-6013

Drug and device information, study documents

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