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Clinical Comparison of Two Daily Disposable Soft Contact Lenses

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ClinicalTrials.gov Identifier: NCT03518008
Recruitment Status : Completed
First Posted : May 8, 2018
Results First Posted : April 3, 2019
Last Update Posted : April 3, 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
Conditions Myopia
Refractive Errors
Interventions Device: verofilcon A contact lenses
Device: somofilcon A contact lenses
Enrollment 22
Recruitment Details Subjects were recruited from 1 investigative site located in the United States.
Pre-assignment Details A total of 22 subjects signed informed consent to participate in the study. This reporting group includes all randomized and exposed subjects (22).
Arm/Group Title DDT2, Then Clariti 1 Day Clariti 1 Day, Then DDT2
Hide Arm/Group Description Verofilcon A contact lenses worn first, with somofilcon A contact lenses worn second. Each product will be worn bilaterally (in both eyes) for 1 week in a daily disposable modality. Somofilcon A contact lenses worn first, with verofilcon A contact lenses worn second. Each product will be worn bilaterally for 1 week in a daily disposable modality.
Period Title: Period 1, First Week of Wear
Started 11 11
Completed 11 11
Not Completed 0 0
Period Title: Period 2, Second Week of Wear
Started 11 11
Completed 11 10
Not Completed 0 1
Reason Not Completed
Family emergency             0             1
Arm/Group Title Overall
Hide Arm/Group Description Verofilcon A and somofilcon A contact lenses worn during Period 1 and Period 2 in a crossover assignment, as randomized.
Overall Number of Baseline Participants 22
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 22 participants
32.1  (6.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
Female
14
  63.6%
Male
8
  36.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
Hispanic or Latino
3
  13.6%
Not Hispanic or Latino
19
  86.4%
Unknown or Not Reported
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
White
22
 100.0%
Black or African American
0
   0.0%
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Other
0
   0.0%
1.Primary Outcome
Title Overall Quality of Vision
Hide Description Overall quality of vision was measured as a subjective rating, collected binocularly on a scale of 1 (Poor) to 10 (Excellent). No inferences were made; therefore, no hypotheses were formulated.
Time Frame Day 8, each product
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title DD T2 Clariti 1 Day
Hide Arm/Group Description:
Verofilcon A contact lenses worn bilaterally (in both eyes) during Period 1 or Period 2 for 1 week in a daily disposable modality
Somofilcon A contact lenses worn bilaterally during Period 1 or Period 2 for 1 week in a daily disposable modality.
Overall Number of Participants Analyzed 22 22
Mean (Standard Deviation)
Unit of Measure: units on a scale
9.2  (1.0) 8.6  (1.5)
Time Frame Dispense through study completion, approximately 20 days
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 Clariti 1 Day
Hide Arm/Group Description All subjects exposed to verofilcon A contact lenses All subjects exposed to somofilcon A contact lenses
All-Cause Mortality
DD T2 Clariti 1 Day
Affected / at Risk (%) Affected / at Risk (%)
Total   0/22 (0.00%)   0/22 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
DD T2 Clariti 1 Day
Affected / at Risk (%) Affected / at Risk (%)
Total   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 Clariti 1 Day
Affected / at Risk (%) Affected / at Risk (%)
Total   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 Research
Phone: 1-888-451-3937
EMail: alcon.medinfo@alcon.com
Layout table for additonal information
Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT03518008     History of Changes
Other Study ID Numbers: CLE383-C006
First Submitted: May 1, 2018
First Posted: May 8, 2018
Results First Submitted: March 14, 2019
Results First Posted: April 3, 2019
Last Update Posted: April 3, 2019