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Two Daily Disposable Contact Lenses in Symptomatic Patients

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ClinicalTrials.gov Identifier: NCT03628599
Recruitment Status : Completed
First Posted : August 14, 2018
Results First Posted : July 3, 2019
Last Update Posted : July 3, 2019
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Myopia
Interventions Device: Delefilcon A contact lenses
Device: Senofilcon A contact lenses
Enrollment 39
Recruitment Details Subjects were recruited from 4 investigational sites located in the United States.
Pre-assignment Details Of the 39 enrolled, 2 subjects were discontinued (1 screen failure, 1 due to lens power not available) prior to randomization. This reporting group includes all randomized subjects (37).
Arm/Group Title TOTAL1 1-DAY
Hide Arm/Group Description Delefilcon A contact lenses worn bilaterally (in both eyes) for 4 weeks in a daily disposable modality Senofilcon A contact lenses worn bilaterally for 4 weeks in a daily disposable modality
Period Title: Overall Study
Started 18 19
Completed 18 18
Not Completed 0 1
Reason Not Completed
Adverse Event             0             1
Arm/Group Title TOTAL1 1-DAY Total
Hide Arm/Group Description Delefilcon A contact lenses worn bilaterally for 4 weeks in a daily disposable modality Senofilcon A contact lenses worn bilaterally for 4 weeks in a daily disposable modality Total of all reporting groups
Overall Number of Baseline Participants 18 19 37
Hide Baseline Analysis Population Description
This analysis population includes all subjects/eyes exposed to any test or control product evaluated in the study (Safety Analysis Set).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants 19 participants 37 participants
36.2  (8.4) 36.9  (9.2) 36.6  (8.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 19 participants 37 participants
Female
12
  66.7%
16
  84.2%
28
  75.7%
Male
6
  33.3%
3
  15.8%
9
  24.3%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 19 participants 37 participants
White
18
 100.0%
18
  94.7%
36
  97.3%
Black or African American
0
   0.0%
1
   5.3%
1
   2.7%
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Other
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Monocular Corrected Distance Visual Acuity (VA)
Hide Description Monocular (each eye) corrected (with spectacles or other visual corrective devices) VA was performed under dimmed room illumination using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart at distance. VA was reported in logMAR ("logarithm of the minimum angle of resolution"), with a lower logMAR indicating better visual acuity. No inferential hypotheses was planned for this endpoint.
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set with non-missing response
Arm/Group Title TOTAL1 1-DAY
Hide Arm/Group Description:
Delefilcon A contact lenses worn bilaterally for 4 weeks in a daily disposable modality
Senofilcon A contact lenses worn bilaterally for 4 weeks in a daily disposable modality
Overall Number of Participants Analyzed 18 18
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
36 36
Mean (Standard Deviation)
Unit of Measure: logMAR
-0.01  (0.04) -0.02  (0.05)
Time Frame Dispense through study completion, an average of 4 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 study lenses. 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. "At Risk" population for ocular AEs is included with unit of "eyes."
 
Arm/Group Title TOTAL1 Ocular - Right Eye TOTAL1 Ocular - Left Eye TOTAL1 Non-ocular 1-DAY Ocular - Right Eye 1-DAY Ocular - Left Eye 1-DAY Non-ocular
Hide Arm/Group Description Right eyes exposed to delefilcon A contact lenses Left eyes exposed to delefilcon A contact lenses All subjects exposed to delefilcon A contact lenses Right eyes exposed to senofilcon A contact lenses Left eyes exposed to senofilcon A contact lenses All subjects exposed to senofilcon A contact lenses
All-Cause Mortality
TOTAL1 Ocular - Right Eye TOTAL1 Ocular - Left Eye TOTAL1 Non-ocular 1-DAY Ocular - Right Eye 1-DAY Ocular - Left Eye 1-DAY Non-ocular
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/18 (0.00%)   0/18 (0.00%)   0/19 (0.00%)   0/19 (0.00%)   0/19 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
TOTAL1 Ocular - Right Eye TOTAL1 Ocular - Left Eye TOTAL1 Non-ocular 1-DAY Ocular - Right Eye 1-DAY Ocular - Left Eye 1-DAY Non-ocular
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/18 (0.00%)   0/18 (0.00%)   0/19 (0.00%)   0/19 (0.00%)   0/19 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
TOTAL1 Ocular - Right Eye TOTAL1 Ocular - Left Eye TOTAL1 Non-ocular 1-DAY Ocular - Right Eye 1-DAY Ocular - Left Eye 1-DAY Non-ocular
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/18 (0.00%)   0/18 (0.00%)   1/19 (5.26%)   1/19 (5.26%)   1/19 (5.26%) 
Eye disorders             
Conjunctival disorder  1  0/18 (0.00%)  0/18 (0.00%)  0/18 (0.00%)  1/19 (5.26%)  1/19 (5.26%)  0/19 (0.00%) 
Infections and infestations             
Sinusitis  1  0/18 (0.00%)  0/18 (0.00%)  0/18 (0.00%)  0/19 (0.00%)  0/19 (0.00%)  1/19 (5.26%) 
1
Term from vocabulary, MedDRA (21.0)
Indicates events were collected by systematic assessment
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: CDMA Project Lead
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: NCT03628599     History of Changes
Other Study ID Numbers: CLS312-P001
First Submitted: August 9, 2018
First Posted: August 14, 2018
Results First Submitted: June 13, 2019
Results First Posted: July 3, 2019
Last Update Posted: July 3, 2019