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ACUVUE® OASYS® 1-DAY vs DAILIES TOTAL1®

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ClinicalTrials.gov Identifier: NCT02750813
Recruitment Status : Completed
First Posted : April 26, 2016
Results First Posted : September 26, 2017
Last Update Posted : July 2, 2018
Sponsor:
Information provided by (Responsible Party):
Alcon Research ( Alcon, a Novartis Company )

Brief Summary:
The purpose of this study is to compare the lens fit characteristics, specifically lens centration, of ACUVUE® OASYS® 1-DAY (AO1D) contact lenses and DAILIES TOTAL1® (DT1) contact lenses.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 252 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: ACUVUE® OASYS® 1-DAY vs DAILIES TOTAL1®: Clinical Comparison in a Symptomatic Population
Actual Study Start Date : April 27, 2016
Actual Primary Completion Date : August 17, 2016
Actual Study Completion Date : August 17, 2016

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Arm Intervention/treatment
DT1, then AO1D
Delefilcon A contact lenses worn first, followed by senofilcon A contact lenses. Each product worn bilaterally (in both eyes) for 14 days in a daily wear, daily disposable modality.
Device: Delefilcon A contact lenses
Other Name: DAILIES TOTAL1® (DT1)

Device: Senofilcon A contact lenses
Other Name: ACUVUE® OASYS 1-Day with HydraLuxe™ (AO1D)

AO1D, then DT1
Senofilcon A contact lenses worn first, followed by delefilcon A contact lenses. Each product worn bilaterally for 14 days in a daily wear, daily disposable modality.
Device: Delefilcon A contact lenses
Other Name: DAILIES TOTAL1® (DT1)

Device: Senofilcon A contact lenses
Other Name: ACUVUE® OASYS 1-Day with HydraLuxe™ (AO1D)




Primary Outcome Measures :
  1. Percentage of Lenses Graded as 0 or 1 for Lens Centration at Day 14 [ Time Frame: Day 14, each product ]
    Lens centration, was assessed by the investigator for each eye individually and rated on a 5-point scale: 0=centered/optimal, 1=slight decentration, 2=mild decentration, 3=moderate decentration, 4=severe decentration. The combined percentage of lenses assessed as "centered" or "slight decentration" is reported. Lenses from both eyes contributed to the percentage.


Secondary Outcome Measures :
  1. Ex Vivo Critical Coefficient of Friction (CCOF) at Day 14 [ Time Frame: Day 14, each product ]
    The ex vivo CCOF (ratio of the force of friction between two bodies and the force pressing them together) was measured by the incline plane technique after 16 hours of lens wear. Worn lenses were collected and analyzed for a subset of subjects (all subjects from one site only) who attended the Day 14 visit (Visit 2 and Visit 3) after 16 hours of lens wear. Only lens worn on the right eye (OD) was measured in each subject per each lens brand. CCOF values for contact lenses range from near zero to approximately 0.10 using the inclined plane method. A lower CCOF indicates higher contact lens lubricity.



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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:

  • Must sign informed consent form;
  • Adapted, current daily disposable soft contact lens wearer who typically wears lenses every day, or at least 5 days per week, 6 hours per day;
  • Symptoms of contact lens discomfort as defined by the Symptomatology (Eligibility) Pre-screening questionnaire;
  • Prescription within -1.00 Diopter (D) to -6.00D to be fitted with study contact lenses;
  • Cylinder equal or lower than -0.75D in both eyes;
  • Vision correctable to 20/25 or 0.1 logMAR (Logarithmic minimum angle of resolution) or better in each eye at distance with both study lenses at Visit 1;
  • Can be successfully fitted with both study lenses at Visit 1;
  • Willing to wear lenses every day or at least 5 days per week, 6 hours per day and attend all 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 1 lens;
  • Fitted with monovision;
  • Prior refractive surgery;
  • History of herpetic keratitis, ocular surgery, or irregular cornea;
  • Pregnant or lactating;
  • Use of mechanical eyelid therapy or eyelid scrubs within 14 days before Visit 1 and not willing to discontinue during the study;
  • Participation in any clinical study within 30 days of Visit 1;
  • Current DT1 or AO1D lens wearer;
  • Other protocol-specified exclusion criteria may apply.

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): NCT02750813


Locations
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United States, Texas
Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon, a Novartis Company
Investigators
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Study Director: Sr. Clinical Manager, Global Medical Affairs, GCRA Alcon, A Novartis Division

Additional Information:
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Responsible Party: Alcon, a Novartis Company
ClinicalTrials.gov Identifier: NCT02750813     History of Changes
Other Study ID Numbers: CLV771-P001
First Posted: April 26, 2016    Key Record Dates
Results First Posted: September 26, 2017
Last Update Posted: July 2, 2018
Last Verified: August 2017

Additional relevant MeSH terms:
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Refractive Errors
Eye Diseases