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DAILIES TOTAL1® - Comparative Assessment of Tear Film Evaporation

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ClinicalTrials.gov Identifier: NCT02517567
Recruitment Status : Completed
First Posted : August 7, 2015
Results First Posted : February 1, 2018
Last Update Posted : July 2, 2018
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Study Description
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Brief Summary:
The purpose of this study is to evaluate the tear film evaporation of symptomatic soft contact lens wearers in the absence of contact lens wear and after at least 8 hours of contact lens wear.

Condition or disease Intervention/treatment Phase
Refractive Error Device: Delefilcon A contact lenses Device: Narafilcon A contact lenses Device: Somofilcon A contact lenses Not Applicable

Detailed Description:
This study consists of 5 visits (1 screening, 4 assessment) with a maximum of 6 days between assessment visits and at least 24 hours of no lens wear the day prior to the visit. Each subject will be randomized to a crossover sequence of 4 periods. Different study lenses will be worn during 3 of the periods, for at least 8 hours each, and the remaining period will have no lens wear.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Pilot Study on the Effect of Daily Disposable Silicone Hydrogel Contact Lenses on Tear Film Lipids
Actual Study Start Date : September 21, 2015
Actual Primary Completion Date : April 22, 2016
Actual Study Completion Date : April 22, 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Sequence 1
Delefilcon A, then narafilcon A, then somofilcon A, then no lens wear. Each contact lens product was worn for 8 hours. The 'No Lens wear' treatment was evaluated over an 8 hour period.
 Device: Delefilcon A contact lenses
Daily disposable, silicone hydrogel contact lenses used according to manufacturer's instructions
Other Name: DAILIES TOTAL1®

Device: Narafilcon A contact lenses
Daily disposable, silicone hydrogel contact lenses used according to manufacturer's instructions
Other Name: 1-DAY ACUVUE® TruEye®

Device: Somofilcon A contact lenses
Daily disposable, silicone hydrogel contact lenses used according to manufacturer's instructions
Other Name: clariti® 1 day
Sequence 2
Narafilcon A, then no lens wear, then delefilcon A, then somofilcon A. Each contact lens product was worn for 8 hours. The 'No Lens wear' treatment was evaluated over an 8 hour period.
 Device: Delefilcon A contact lenses
Daily disposable, silicone hydrogel contact lenses used according to manufacturer's instructions
Other Name: DAILIES TOTAL1®

Device: Narafilcon A contact lenses
Daily disposable, silicone hydrogel contact lenses used according to manufacturer's instructions
Other Name: 1-DAY ACUVUE® TruEye®

Device: Somofilcon A contact lenses
Daily disposable, silicone hydrogel contact lenses used according to manufacturer's instructions
Other Name: clariti® 1 day
Sequence 3
Somofilcon A, then delefilcon A, then no lens wear, then narafilcon A. Each contact lens product was worn for 8 hours. The 'No Lens wear' treatment was evaluated over an 8 hour period.
 Device: Delefilcon A contact lenses
Daily disposable, silicone hydrogel contact lenses used according to manufacturer's instructions
Other Name: DAILIES TOTAL1®

Device: Narafilcon A contact lenses
Daily disposable, silicone hydrogel contact lenses used according to manufacturer's instructions
Other Name: 1-DAY ACUVUE® TruEye®

Device: Somofilcon A contact lenses
Daily disposable, silicone hydrogel contact lenses used according to manufacturer's instructions
Other Name: clariti® 1 day
Sequence 4
No lens wear, then somofilcon A, then narafilcon A, then delefilcon A. Each contact lens product was worn for 8 hours. The 'No Lens wear' treatment was evaluated over an 8 hour period.
 Device: Delefilcon A contact lenses
Daily disposable, silicone hydrogel contact lenses used according to manufacturer's instructions
Other Name: DAILIES TOTAL1®

Device: Narafilcon A contact lenses
Daily disposable, silicone hydrogel contact lenses used according to manufacturer's instructions
Other Name: 1-DAY ACUVUE® TruEye®

Device: Somofilcon A contact lenses
Daily disposable, silicone hydrogel contact lenses used according to manufacturer's instructions
Other Name: clariti® 1 day


Outcome Measures
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Primary Outcome Measures :
  1. Tear Film Evaporation Rate [ Time Frame: Day 1, Hour 8, each product ]
    Tear film evaporation rate (amount of tears (grams or g) that evaporates over a surface area (m2) per hour (h)) assessment was performed using the VapoMeter as a non-invasive measurement of tear film evaporation over 10 seconds. Measurements were taken on both the right and left eyes after 8 hours of lens wear or no lens wear, as applicable. A higher evaporation rate can be a contributing factor to eye irritation and lens intolerance.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:

  • Sign an informed consent document;
  • Adapted, current soft contact lens wearer;
  • Symptoms of contact lens discomfort as defined by the Symptomatology (Eligibility) Questionnaire;
  • Can be successfully fitted with study lenses;
  • Willing to wear lenses for a minimum of 8 hours prior to each study visit;
  • Willing to discontinue artificial tears and rewetting drops usage on the days of study visits;
  • Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

  • Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear;
  • Use of systemic or ocular medications for which contact lens wear could be contraindicated as determined by the investigator;
  • Monocular (only 1 eye with functional vision) or fit with only one lens;
  • History of herpetic keratitis, ocular surgery, or irregular cornea;
  • Known pregnancy and lactation;
  • Other protocol-specified exclusion criteria may apply.
Contacts and Locations
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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): NCT02517567


Sponsors and Collaborators
Alcon Research
Investigators
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Study Director: Clinical Manager, Clinical Trial Management Alcon Research
More Information
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Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT02517567    
Other Study ID Numbers: CLT978-P001
First Posted: August 7, 2015    Key Record Dates
Results First Posted: February 1, 2018
Last Update Posted: July 2, 2018
Last Verified: July 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Refractive Errors
Eye Diseases