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Direct Application of Systane Complete to Contact Lenses

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03848221
Recruitment Status : Completed
First Posted : February 20, 2019
Last Update Posted : December 16, 2019
Sponsor:
Collaborator:
Alcon Research
Information provided by (Responsible Party):
Andrew Pucker, University of Alabama at Birmingham

Brief Summary:
A common first line treatment for patients with dryness symptoms or contact lens discomfort is the application of artificial tears or rewetting drops, respectively. Rewetting drops are specifically formulated for use with contact lenses while artificial tears are indicated for dry eye. Modern rewetting drops and artificial tears have similar formulations with similar preservatives, preservatives that have been shown to be compatible with contact lenses. While rewetting drops and artificial tears are regulated under different U.S. Food & Drug Administration policies, artificial tears are not specifically indicated for direct use with contact lenses. Nevertheless, clinicians commonly prescribe artificial tears to contact lens wearers likely because newer formulations of artificial tear have the potential to outperform available rewetting drops. The safety and efficacy of using artificial tears with contact lenses for the treatment of discomfort is supported by Caffery and Josephson and Ozkan and Papas who found that artificial tears significantly reduces dryness symptoms in contact lens wearers. Thus, the purpose of this study is to test the safety of directly applying a new artificial tear, Systane Complete, to the contact lens wearing eye and its ability to alleviate symptoms while wearing contact lenses during the day.

Condition or disease Intervention/treatment Phase
Dry Eye Contact Lens Complication Drug: Systane Complete Drug: Sensitive Eyes Rewetting Drops Phase 4

Detailed Description:

Soft contact lenses are the ideal vision correction choice for many patients because soft contact lenses allow patients to have better and less restricted vision, they allow for an increased ability to perform work tasks and play sports, and they provide patients with a better perceived cosmetic appearance compared to spectacle lenses. While millions of people worldwide benefit from contact lenses, many of these patients experience contact lens discomfort, which limits their wear time and in many instances eventually result in discontinuation of contact lens use. In fact, 21% to 64% of contact lens wearers permanently discontinue contact lens use because of ocular discomfort. Contact lens discomfort is currently defined as "a condition characterized by episodic or persistent adverse ocular sensations related to lens wear, either with or without visual disturbance, resulting from reduced compatibility between the contact lens and the ocular environment, which can lead to decreased wearing time and discontinuation of contact lens wear." Although contact lens discomfort may stem from the lens itself, a situation that can be corrected by such means as switching to an alternative material or wear schedule, contact lens discomfort more typically occurs from ocular surface disease.

A common first line treatment for patients with dryness symptoms or contact lens discomfort is the application of artificial tears or rewetting drops, respectively. Rewetting drops are specifically formulated for use with contact lenses while artificial tears are indicated for dry eye. Modern rewetting drops and artificial tears have similar formulations with similar preservatives, preservatives that have been shown to be compatible with contact lens use. While rewetting drops and artificial tears are regulated under different U.S. Food & Drug Administration policies, artificial tears are not specifically indicated for use with contact lenses. Nevertheless, clinicians commonly prescribe artificial tears to contact lens wearers likely because newer formulations of artificial tear have the potential to outperform available rewetting drops (e.g., some artificial tears have lipid supplements that have the potential to restore the external tear lipid layer). The safe and effective use of artificial tears with contact lenses is supported by Caffery and Josephson and Ozkan and Papas who found that artificial tears significantly reduce dryness symptoms in contact lens wearers. However, the community currently lacks a rigorous scientific study aimed at understanding the utility of lipid-containing artificial tear (or rewetting drop) for alleviating contact lens discomfort while patients are wearing their contact lenses. Systane Complete, a new formulation of artificial tears, combines elements from both Systane Ultra (indicated for aqueous deficient dry eye) and Systane Balance (lipid-containing artificial tear indicated for evaporative dry eye). Thus, the purpose of this study is to test the safety of Systane Complete and its ability to alleviate contact lens discomfort during the day while subjects are wearing their contact lenses. This goal will be accomplished by randomizing subjects to either Systane Complete, a commercially available rewetting drop, or no treatment.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 73 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Investigator Masked, Randomized, Clinical Trial
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Masking Description: The investigator will be masked to the subject's treatment. The subjects cannot be fully masked because there is a no treatment control group.
Primary Purpose: Treatment
Official Title: Direct Application of Systane Complete to Contact Lenses for the Treatment of Contact Lens Discomfort
Actual Study Start Date : May 28, 2019
Actual Primary Completion Date : October 20, 2019
Actual Study Completion Date : October 20, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear
Drug Information available for: Systane

Arm Intervention/treatment
Experimental: Systane Complete
Subjects in this group will use Systane Complete before, during, and after contact lens use.
Drug: Systane Complete
Systane Complete is an artificial tear.

Active Comparator: Sensitive Eyes Rewetting Drops
Subjects in this group will use Sensitive Eyes Rewetting Drops before, during, and after contact lens use.
Drug: Sensitive Eyes Rewetting Drops
Sensitive Eyes Rewetting Drops is a rewetting drop.

No Intervention: No Treatment
Subjects in this group will not be allowed to use artificial tears or rewetting drops during the study.



Primary Outcome Measures :
  1. Percentage of participants with ocular surface damage as measured by the Brien Holden Vision Institute (BHVI grading scale) [ Time Frame: Baseline through 2 Weeks ]
    The Corneal Staining Scores are measured by the BHVI grading scale. The grading scales are a quick reference to the key signs associated with contact lens related inflammation and infection. Used as a reference tool in the clinic, they provide a guide for determining how much normal ocular appearance has changed in a patient, and can help inform clinical management decisions. The range of the scores are: 0-4 in five regions (total sum score = 20). A lower score indicates a better outcome.


Secondary Outcome Measures :
  1. Identifying contact lens (CL) participants with dry eye disease (DED), as measured by the Contact Lens Dry Eye Questionnaire-4 items (CLDEQ-4). [ Time Frame: Baseline through 2 Weeks ]
    The CLDEQ-4 is a contact lens specific symptoms survey, we are using the Rasch validated version; range = 0-18 with 18 being most symptomatic.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Daily disposable contact lens wearers
  • 20/30 visual acuity or better
  • Self-report contact lens discomfort
  • Contact Lens Dry Eye Questionnaire (CLDEQ)-8 scores ≥ 12

Exclusion Criteria:

  • Other contact lens modalities/wear schedules (e.g., two week and monthly replacement CLs, gas permeable CLs)
  • Non-compliant daily disposable contact lens wearers
  • Systemic health conditions that alter tear film physiology (e.g., primary and secondary Sjögren's syndrome)
  • History of ocular surgery within the past 12 months
  • History of severe ocular trauma
  • History of active ocular infection or inflammation
  • Isotretinoin-derivatives use
  • Ocular medication use
  • Pregnant or breast feeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03848221


Locations
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United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
United States, New York
Lindenhurst Eye Physicians & Surgeons, P.C.
Babylon, New York, United States, 11702
United States, Tennessee
Southern College of Optometry
Memphis, Tennessee, United States, 38104
Sponsors and Collaborators
University of Alabama at Birmingham
Alcon Research

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Responsible Party: Andrew Pucker, Assistant Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03848221    
Other Study ID Numbers: 000523741
First Posted: February 20, 2019    Key Record Dates
Last Update Posted: December 16, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share individual subject data.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Andrew Pucker, University of Alabama at Birmingham:
Systane Complete
Dry Eye
Contact Lens Discomfort
Artificial Tears
Rewetting Drops
Additional relevant MeSH terms:
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Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Lubricant Eye Drops
Ophthalmic Solutions
Pharmaceutical Solutions