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OpenTrials
Completed

NCT Number: NCT03466086

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.

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Key information

Conditions

Age range

18 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The University of Manchester

Manchester, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

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.

Treatment and study plan

Test Eye Drops

Device

blink® intensive TRIPLE ACTION 3 in 1 eye drops

Control Eye Drops

Device

Systane® BALANCE eye drops

Primary outcomes

  1. Ocular Comfort

    Time frame: 1-Week Follow-up

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

Secondary outcomes

  1. Subjective Dryness Rating

    Time frame: 1-Week Follow-up

    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

Sponsors and collaborators

Lead sponsor

Johnson & Johnson Vision Care, Inc.

Industry

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Mar 15, 2018
Registry last updated
Jun 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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