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DD T2 Daily Disposable Registration Trial

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ClinicalTrials.gov Identifier: NCT03305770
Recruitment Status : Completed
First Posted : October 10, 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: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Myopia
Refractive Errors
Interventions Device: verofilcon A contact lenses
Device: delefilcon A contact lenses
Enrollment 107
Recruitment Details Subjects were recruited from 6 investigational sites located in the US.
Pre-assignment Details This reporting group includes all randomized subjects (107).
Arm/Group Title DD T2 DT 1
Hide Arm/Group Description Verofilcon A contact lenses worn in both eyes for 3 months in a daily wear, daily disposable modality. A new pair of study lenses were inserted each day and discarded at the end of the day. Delefilcon A contact lenses worn in both eyes for 3 months in a daily wear, daily disposable modality. A new pair of study lenses were inserted each day and discarded at the end of the day.
Period Title: Overall Study
Number of participants Number of units (Eyes) Number of participants Number of units (Eyes)
Started [1] 70 140 37 74
Enrolled Dispensed Analysis Set [2] 70 140 36 72
Completed Analysis Set [3] 69 138 36 72
Completed 69 138 36 72
Not Completed 1 2 1 2
Reason Not Completed
Physician Decision - prior to dispense             0                         1            
Subject moved             1                         0            
[1]
All randomized subjects
[2]
Enrolled subjects/eyes exposed to study lenses
[3]
Subjects/eyes in the Enrolled Dispensed set that completed the study
Arm/Group Title DD T2 DT 1 Total
Hide Arm/Group Description Verofilcon A contact lenses worn in both eyes for 3 months in a daily wear, daily disposable modality. A new pair of study lenses were inserted each day and discarded at the end of the day. Delefilcon A contact lenses worn in both eyes for 3 months in a daily wear, daily disposable modality. A new pair of study lenses will be inserted each day and discarded at the end of the day. Total of all reporting groups
Overall Number of Baseline Participants 70 37 107
Hide Baseline Analysis Population Description
This analysis set includes all randomized subjects.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 70 participants 37 participants 107 participants
34.3  (6.3) 31.3  (7.6) 33.3  (6.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 70 participants 37 participants 107 participants
Female
51
  72.9%
30
  81.1%
81
  75.7%
Male
19
  27.1%
7
  18.9%
26
  24.3%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 70 participants 37 participants 107 participants
White 65 33 98
Black or African American 3 3 6
American Indian or Alaska Native 0 0 0
Asian 1 1 2
Native Hawaiian or Other Pacific Islander 0 0 0
Other 1 0 1
Multi-racial 0 0 0
1.Primary Outcome
Title Monocular Visual Acuity (VA) With Contact Lenses at Each Visit (Snellen)
Hide Description VA was assessed for each eye individually using a Snellen chart at a distance of 4 meters. A 20/20 Snellen acuity is considered normal distance eyesight. No formal hypotheses were formulated; hence no inferential testing was performed.
Time Frame Dispense, Week 1, Week 2, Month 1, Month 2, Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
Completed Analysis Set
Arm/Group Title DD T2 DT 1
Hide Arm/Group Description:
Verofilcon A contact lenses worn in both eyes for 3 months in a daily wear, daily disposable modality. A new pair of study lenses were inserted each day and discarded at the end of the day.
Delefilcon A contact lenses worn in both eyes for 3 months in a daily wear, daily disposable modality. A new pair of study lenses will be inserted each day and discarded at the end of the day.
Overall Number of Participants Analyzed 69 36
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
138 72
Measure Type: Number
Unit of Measure: eyes
Dispense @ 20/15 74 32
Dispense @ 20/20 62 40
Dispense @ 20/25 2 0
Dispense @ 20/30 0 0
Week 1 @ 20/15 75 36
Week 1 @ 20/20 58 36
Week 1 @ 20/25 4 0
Week 1 @ 20/30 1 0
Week 2 @ 20/15 69 35
Week 2 @ 20/20 65 37
Week 2 @ 20/25 4 0
Week 2 @ 20/30 0 0
Month 1 @ 20/15 62 31
Month 1 @ 20/20 72 40
Month 1 @ 20/25 4 1
Month 1 @ 20/30 0 0
Month 2 @ 20/15 63 33
Month 2 @ 20/20 68 36
Month 2 @ 20/25 7 3
Month 2 @ 20/30 0 0
Month 3 @ 20/15 63 35
Month 3 @ 20/20 69 37
Month 3 @ 20/25 6 0
Month 3 @ 20/30 0 0
Time Frame Dispense through study completion, an average of 15 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. Completed Analysis Set. "At Risk" population for ocular AEs is included with unit of “eyes."
 
Arm/Group Title DD T2 Ocular DD T2 Non-ocular DT 1 Ocular DT 1 Non-ocular
Hide Arm/Group Description Eyes exposed to verofilcon A contact lenses Subjects exposed to verofilcon A contact lenses Eyes exposed to delefilcon A contact lenses Subjects exposed to delefilcon A contact lenses
All-Cause Mortality
DD T2 Ocular DD T2 Non-ocular DT 1 Ocular DT 1 Non-ocular
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/138 (0.00%)   0/69 (0.00%)   0/72 (0.00%)   0/36 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
DD T2 Ocular DD T2 Non-ocular DT 1 Ocular DT 1 Non-ocular
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/138 (0.00%)   0/69 (0.00%)   0/72 (0.00%)   0/36 (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 Ocular DD T2 Non-ocular DT 1 Ocular DT 1 Non-ocular
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/138 (0.00%)   0/69 (0.00%)   0/72 (0.00%)   0/36 (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 Director Project Leadership
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: NCT03305770     History of Changes
Other Study ID Numbers: CLE383-C005
First Submitted: October 5, 2017
First Posted: October 10, 2017
Results First Submitted: January 30, 2019
Results First Posted: February 22, 2019
Last Update Posted: February 22, 2019