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Clinical Evaluation of ACUVUE® OASYS® 1-Day and ACUVUE® OASYS®

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: NCT02696317
Recruitment Status : Completed
First Posted : March 2, 2016
Results First Posted : June 26, 2017
Last Update Posted : July 2, 2018
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Single (Investigator);   Primary Purpose: Other
Condition Refractive Error
Interventions Device: Senofilcon A contact lenses with HydraLuxe™
Device: Senofilcon A contact lenses
Enrollment 84
Recruitment Details Subjects were recruited from one study center located in the United Kingdom.
Pre-assignment Details Of the 84 enrolled, 1 subject was exited as a screen failure prior to randomization. One subject was discontinued after randomization but prior to study lenses parameter optimization. This reporting group includes all subjects exposed to habitual or study lenses (82).
Arm/Group Title Habitual, AO1D, AO Habitual, AO, AO1D
Hide Arm/Group Description Habitual contact lenses worn first (to understand the baseline performance in this population), followed by senofilcon A contact lenses with HydraLuxe™ in Period 1 and senofilcon A contact lenses in Period 2. Each product worn bilaterally (in both eyes) for 10 days in a daily wear, daily disposable modality. Habitual contact lenses worn first (to understand the baseline performance in this population), followed by senofilcon A contact lenses in Period 1, then senofilcon A contact lenses with HydraLuxe™ in Period 2. Each product worn bilaterally for 10 days in a daily wear, daily disposable modality.
Period Title: Habitual, 10 Days of Wear
Started 42 40
Completed 40 36
Not Completed 2 4
Reason Not Completed
Withdrawal by Subject             2             4
Period Title: Period 1, 10 Days of Wear
Started 40 36
Completed 40 36
Not Completed 0 0
Period Title: Period 2, 10 Days of Wear
Started 40 36
Completed 39 36
Not Completed 1 0
Reason Not Completed
Withdrawal by Subject             1             0
Arm/Group Title Overall
Hide Arm/Group Description Habitual contact lenses worn first, followed by senofilcon A contact lenses with HydraLuxe™ and senofilcon A contact lenses in Periods 1 and 2, as randomized. Each product worn bilaterally for 10 days in a daily wear, daily disposable modality.
Overall Number of Baseline Participants 82
Hide Baseline Analysis Population Description
This analysis population includes all randomized subjects who were exposed to any study lenses used for parameter optimization, habitual lenses, or study lenses dispensed for 10-day wear (Full Analysis Set).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 82 participants
35.3  (11.93)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 82 participants
Female
55
  67.1%
Male
27
  32.9%
1.Primary Outcome
Title Tear Film Evaporation Rate in a Normal Environment After 10 ± 3 Days of Wear (Pre RH)
Hide Description Tear film evaporation rate (amount of tears that evaporates over a surface area per seconds) assessment was performed using the Oregon Health Sciences University Evaporometer. Measurements were taken on both the right and left eyes after 3 hours of wear in a normal environment after 10 ± 3 days of lens wear. The temperature and humidity were measured within an air chamber around the ocular surface with the eyes opened and closed. The evaporation from the ocular surface was calculated as the difference between the evaporation rate of the skin taken during the closed eye measurement and the evaporation rate taken during the open eye measurement. The rate of evaporation was measured in g/cm2/sec for 2 humidity ranges. A higher evaporation rate can be a contributing factor to eye irritation and lens intolerance.
Time Frame Day 10 ± 3 days, each product
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set. Number Analyzed is the number of eyes with non-missing response.
Arm/Group Title ACUVUE OASYS 1-DAY ACUVUE OASYS
Hide Arm/Group Description:
Senofilcon A contact lenses with HydraLuxe™ worn bilaterally for 10 days in a daily wear, daily disposable modality
Senofilcon A contact lenses worn bilaterally for 10 days in a daily wear, daily disposable modality
Overall Number of Participants Analyzed 76 75
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
152 150
Mean (Standard Deviation)
Unit of Measure: 10^-7g/cm^2/s
25-35% Relative Humidity 11.97  (6.447) 10.66  (5.700)
35-45% Relative Humidity 8.51  (5.562) 7.94  (5.289)
2.Secondary Outcome
Title Tear Film Evaporation Rate After 10 ± 3 Days of Wear and After 3 Hours Exposure to Reduced Humidity (Post RH)
Hide Description Tear film evaporation rate (amount of tears that evaporates over a surface area per seconds) assessment was performed using the Oregon Health Sciences University Evaporometer. Measurements were taken on both the right and left eyes after 6 hours of lens wear, including 3 hours of wear in a 20% reduced humidity environment (20% RH), after 10 ± 3 days of lens wear. The temperature and humidity were measured within an air chamber around the ocular surface with the eyes opened and closed. The evaporation from the ocular surface was calculated as the difference between the evaporation rate of the skin taken during the closed eye measurement and the evaporation rate taken during the open eye measurement. The rate of evaporation was measured in g/cm2/sec for 2 humidity ranges. A higher evaporation rate can be a contributing factor to eye irritation and lens intolerance.
Time Frame Day 10 ± 3 days, each product
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set. Number Analyzed is the number of eyes with non-missing response.
Arm/Group Title ACUVUE OASYS 1-DAY ACUVUE OASYS
Hide Arm/Group Description:
Senofilcon A contact lenses with HydraLuxe™ worn bilaterally for 10 days in a daily wear, daily disposable modality
Senofilcon A contact lenses worn bilaterally for 10 days in a daily wear, daily disposable modality
Overall Number of Participants Analyzed 76 75
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
152 150
Mean (Standard Deviation)
Unit of Measure: 10^-7g/cm^2/s
25-35% Relative Humidity 11.51  (5.773) 11.72  (5.830)
35-45% Relative Humidity 8.78  (5.732) 8.68  (5.352)
3.Secondary Outcome
Title Pre-Lens Tear Film Minimum Protected Area (MPA) in a Normal Environment After 10 ± 3 Days of Wear (Pre RH)
Hide Description MPA is the minimum area of the contact lens surface (expressed in %) that is protected by the tear film during the entire interblink period. Pre-lens tear film MPA was assessed in a normal environment following 3 hours of wear. Higher values indicate less dry and more eye comfort.
Time Frame Day 10 ± 3 days, each product
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set. Number Analyzed is the number of eyes with non-missing response.
Arm/Group Title ACUVUE OASYS 1-DAY ACUVUE OASYS
Hide Arm/Group Description:
Senofilcon A contact lenses with HydraLuxe™ worn bilaterally for 10 days in a daily wear, daily disposable modality
Senofilcon A contact lenses worn bilaterally for 10 days in a daily wear, daily disposable modality
Overall Number of Participants Analyzed 76 75
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
152 150
Mean (Standard Deviation)
Unit of Measure: percentage of contact lens surface area
84.64  (27.835) 85.37  (25.634)
4.Secondary Outcome
Title Pre-Lens Tear Film MPA After 10 ± 3 Days of Wear and After 3 Hours Exposure to Reduced Humidity (Post RH)
Hide Description MPA is the minimum area of the contact lens surface (expressed in %) that is protected by the tear film during the entire interblink period. Pre-lens tear film MPA was assessed following 6 hours of wear including 3 hours in a reduced humidity environment (20% RH).. Higher values indicate less dry and more eye comfort.
Time Frame Day 10 ± 3 days, each product
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set. Number Analyzed is the number of eyes with non-missing response.
Arm/Group Title ACUVUE OASYS 1-DAY ACUVUE OASYS
Hide Arm/Group Description:
Senofilcon A contact lenses with HydraLuxe™ worn bilaterally for 10 days in a daily wear, daily disposable modality
Senofilcon A contact lenses worn bilaterally for 10 days in a daily wear, daily disposable modality
Overall Number of Participants Analyzed 76 75
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
152 150
Mean (Standard Deviation)
Unit of Measure: percentage of contact lens surface area
94.14  (14.399) 91.61  (20.004)
Time Frame Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 39 days). AEs are reported as pre-treatment and treatment-emergent.
Adverse Event Reporting Description An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device.
 
Arm/Group Title Pre-treatment Habitual Lenses ACUVUE OASYS 1-DAY ACUVUE OASYS
Hide Arm/Group Description All subjects who consented to participate in the study prior to initiation of study treatment All subjects exposed to habitual contact lenses during Period 1 All subjects exposed to ACUVUE OASYS 1-DAY contact lenses All subjects exposed to ACUVUE OASYS contact lenses
All-Cause Mortality
Pre-treatment Habitual Lenses ACUVUE OASYS 1-DAY ACUVUE OASYS
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/84 (0.00%)   0/82 (0.00%)   0/76 (0.00%)   0/76 (0.00%) 
Hide Serious Adverse Events
Pre-treatment Habitual Lenses ACUVUE OASYS 1-DAY ACUVUE OASYS
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/84 (0.00%)   0/82 (0.00%)   0/76 (0.00%)   0/76 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pre-treatment Habitual Lenses ACUVUE OASYS 1-DAY ACUVUE OASYS
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/84 (0.00%)   0/82 (0.00%)   0/76 (0.00%)   0/76 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Sr. Brand Lead, Global Medical Affairs, Vision Care
Organization: Alcon, A Novartis Division
Phone: 1-888-451-3937
EMail: alcon.medinfo@alcon.com
Layout table for additonal information
Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT02696317    
Other Study ID Numbers: CLE198-P001
First Submitted: February 24, 2016
First Posted: March 2, 2016
Results First Submitted: June 5, 2017
Results First Posted: June 26, 2017
Last Update Posted: July 2, 2018