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Clinical Comparison of 4 Daily Disposable Soft Contact Lenses

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ClinicalTrials.gov Identifier: NCT03349632
Recruitment Status : Completed
First Posted : November 21, 2017
Results First Posted : February 22, 2019
Last Update Posted : February 22, 2019
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Refractive Error
Interventions Device: verofilcon A contact lenses
Device: senofilcon A contact lenses
Device: stenfilcon A contact lenses
Device: etafilcon A contact lenses
Enrollment 68
Recruitment Details Subjects were recruited from 3 investigational sites located in the United States.
Pre-assignment Details Of the 68 enrolled, 2 subjects exited as screen failures prior to randomization. This reporting group includes all randomized subjects (66).
Arm/Group Title DD T2/Oasys 1-Day (Sequence 1) Oasys 1-Day/DD T2 (Sequence 2) DD T2/MyDay (Sequence 3) MyDay/DD T2 (Sequence 4) DD T2/Moist (Sequence 5) Moist/DD T2 (Sequence 6)
Hide Arm/Group Description Verofilcon A contact lenses worn in Period 1, followed by senofilcon A contact lenses worn in Period 2. Each product worn bilaterally (in both eyes) for 1 week on a daily wear basis, as randomized Senofilcon A contact lenses worn in Period 1, followed by verofilcon A contact lenses worn in Period 2. Each product worn bilaterally for 1 week on a daily wear basis, as randomized Verofilcon A contact lenses worn in Period 1, followed by stenfilcon A contact lenses worn in Period 2. Each product worn bilaterally for 1 week on a daily wear basis, as randomized Stenfilcon A contact lenses worn in Period 1, followed by verofilcon A contact lenses worn in Period 2. Each product worn bilaterally for 1 week on a daily wear basis, as randomized Verofilcon A contact lenses worn in Period 1, followed by etafilcon A contact lenses worn in Period 2. Each product worn bilaterally for 1 week on a daily wear basis, as randomized Etafilcon A contact lenses worn in Period 1, followed by verofilcon A contact lenses worn in Period 2. Each product worn bilaterally for 1 week on a daily wear basis, as randomized
Period Title: Period 1, First Week of Wear
Started 11 11 11 11 11 11
Completed 11 11 11 11 11 11
Not Completed 0 0 0 0 0 0
Period Title: Period 2, Second Week of Wear
Started 11 11 11 11 11 11
Completed 11 11 11 11 11 11
Not Completed 0 0 0 0 0 0
Arm/Group Title Overall
Hide Arm/Group Description Verofilcon A contact lenses with corresponding control product (senofilcon A, stenfilcon A, or etafilcon) worn during Period 1 and Period 2 in a crossover assignment, as randomized.
Overall Number of Baseline Participants 66
Hide Baseline Analysis Population Description
This analysis population includes all subjects/eyes exposed to any study lenses evaluated in this study (Safety Analysis Set).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 66 participants
32.9  (9.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 66 participants
Female
46
  69.7%
Male
20
  30.3%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 66 participants
White
56
  84.8%
Black or African American
6
   9.1%
American Indian or Alaska Native
0
   0.0%
Asian
4
   6.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
1.Primary Outcome
Title Overall Quality of Vision
Hide Description Overall quality of vision was collected binocularly and rated on a 10-point scale with 1 = poor to 10 = excellent. Subjects were asked “Thinking back over the last week, please rate our study lenses. Rate eyes together.” No formal hypotheses was conducted; hence no inferential testing was performed.
Time Frame Day 8, each product
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title DD T2 (Sequence 1 and 2) Oasys 1-Day (Sequence 1 and 2) DD T2 (Sequence 3 and 4) MyDay (Sequence 3 and 4) DD T2 (Sequence 5 and 6) Moist (Sequence 5 and 6)
Hide Arm/Group Description:
Verofilcon A contact lenses worn in Period 1 or Period 2 for 1 week
Senofilcon A contact lenses worn in Period 1 or Period 2 for 1 week
Verofilcon A contact lenses worn in Period 1 or Period 2 for 1 week
Stenfilcon A contact lenses worn in Period 1 or Period 2 for 1 week
Verofilcon A contact lenses worn in Period 1 or Period 2 for 1 week
Etafilcon A contact lenses worn in Period 1 or Period 2 for 1 week
Overall Number of Participants Analyzed 22 22 22 22 22 22
Mean (Standard Deviation)
Unit of Measure: units on a scale
8.5  (1.4) 9.2  (1.3) 8.8  (1.8) 9.4  (0.8) 9.2  (1.1) 8.8  (1.7)
Time Frame Dispense through study completion, an average of 2 weeks
Adverse Event Reporting Description An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Safety Analysis Set, based on treatment-specific exposure.
 
Arm/Group Title DD T2 (Sequence 1 and 2) Oasys 1- Day (Sequence 1 and 2) DD T2 (Sequence 3 and 4) MyDay (Sequence 3 and 4) DD T2 (Sequence 5 and 6) Moist (Sequence 5 and 6)
Hide Arm/Group Description Verofilcon A contact lenses worn in Period 1 or Period 2 for 1 week Senofilcon A contact lenses worn in Period 1 or Period 2 for 1 week Verofilcon A contact lenses worn in Period 1 or Period 2 for 1 week Stenfilcon A contact lenses worn in Period 1 or Period 2 for 1 week Verofilcon A contact lenses worn in Period 1 or Period 2 for 1 week Etafilcon A contact lenses worn in Period 1 or Period 2 for 1 week
All-Cause Mortality
DD T2 (Sequence 1 and 2) Oasys 1- Day (Sequence 1 and 2) DD T2 (Sequence 3 and 4) MyDay (Sequence 3 and 4) DD T2 (Sequence 5 and 6) Moist (Sequence 5 and 6)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/22 (0.00%)   0/22 (0.00%)   0/22 (0.00%)   0/22 (0.00%)   0/22 (0.00%)   0/22 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
DD T2 (Sequence 1 and 2) Oasys 1- Day (Sequence 1 and 2) DD T2 (Sequence 3 and 4) MyDay (Sequence 3 and 4) DD T2 (Sequence 5 and 6) Moist (Sequence 5 and 6)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/22 (0.00%)   0/22 (0.00%)   0/22 (0.00%)   0/22 (0.00%)   0/22 (0.00%)   0/22 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
DD T2 (Sequence 1 and 2) Oasys 1- Day (Sequence 1 and 2) DD T2 (Sequence 3 and 4) MyDay (Sequence 3 and 4) DD T2 (Sequence 5 and 6) Moist (Sequence 5 and 6)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/22 (0.00%)   0/22 (0.00%)   0/22 (0.00%)   0/22 (0.00%)   0/22 (0.00%)   0/22 (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: Senior Clinical Project Lead, GCRA - 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: NCT03349632     History of Changes
Other Study ID Numbers: CLE383-C004
First Submitted: November 17, 2017
First Posted: November 21, 2017
Results First Submitted: January 30, 2019
Results First Posted: February 22, 2019
Last Update Posted: February 22, 2019