Trial Outcomes & Findings for Two Daily Disposable Contact Lenses in Symptomatic Patients (NCT NCT03628599)
NCT ID: NCT03628599
Last Updated: 2019-07-05
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
39 participants
Primary outcome timeframe
Week 4
Results posted on
2019-07-05
Participant Flow
Subjects were recruited from 4 investigational sites located in the United States.
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).
Participant milestones
| Measure |
TOTAL1
Delefilcon A contact lenses worn bilaterally (in both eyes) for 4 weeks in a daily disposable modality
|
1-DAY
Senofilcon A contact lenses worn bilaterally for 4 weeks in a daily disposable modality
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
19
|
|
Overall Study
COMPLETED
|
18
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
TOTAL1
Delefilcon A contact lenses worn bilaterally (in both eyes) for 4 weeks in a daily disposable modality
|
1-DAY
Senofilcon A contact lenses worn bilaterally for 4 weeks in a daily disposable modality
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
Baseline Characteristics
Two Daily Disposable Contact Lenses in Symptomatic Patients
Baseline characteristics by cohort
| Measure |
TOTAL1
n=18 Participants
Delefilcon A contact lenses worn bilaterally for 4 weeks in a daily disposable modality
|
1-DAY
n=19 Participants
Senofilcon A contact lenses worn bilaterally for 4 weeks in a daily disposable modality
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
36.2 years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
36.9 years
STANDARD_DEVIATION 9.2 • n=7 Participants
|
36.6 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 4Population: Safety Analysis Set with non-missing response
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.
Outcome measures
| Measure |
TOTAL1
n=36 Eyes
Delefilcon A contact lenses worn bilaterally for 4 weeks in a daily disposable modality
|
1-DAY
n=36 Eyes
Senofilcon A contact lenses worn bilaterally for 4 weeks in a daily disposable modality
|
|---|---|---|
|
Monocular Corrected Distance Visual Acuity (VA)
|
-0.01 logMAR
Standard Deviation 0.04
|
-0.02 logMAR
Standard Deviation 0.05
|
Adverse Events
TOTAL1 Ocular - Right Eye
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
TOTAL1 Ocular - Left Eye
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
TOTAL1 Non-ocular
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
1-DAY Ocular - Right Eye
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
1-DAY Ocular - Left Eye
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
1-DAY Non-ocular
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
TOTAL1 Ocular - Right Eye
n=18 participants at risk
Right eyes exposed to delefilcon A contact lenses
|
TOTAL1 Ocular - Left Eye
n=18 participants at risk
Left eyes exposed to delefilcon A contact lenses
|
TOTAL1 Non-ocular
n=18 participants at risk
All subjects exposed to delefilcon A contact lenses
|
1-DAY Ocular - Right Eye
n=19 participants at risk
Right eyes exposed to senofilcon A contact lenses
|
1-DAY Ocular - Left Eye
n=19 participants at risk
Left eyes exposed to senofilcon A contact lenses
|
1-DAY Non-ocular
n=19 participants at risk
All subjects exposed to senofilcon A contact lenses
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Sinusitis
|
0.00%
0/18 • Dispense through study completion, an average of 4 weeks
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."
|
0.00%
0/18 • Dispense through study completion, an average of 4 weeks
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."
|
0.00%
0/18 • Dispense through study completion, an average of 4 weeks
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."
|
0.00%
0/19 • Dispense through study completion, an average of 4 weeks
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."
|
0.00%
0/19 • Dispense through study completion, an average of 4 weeks
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."
|
5.3%
1/19 • Dispense through study completion, an average of 4 weeks
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."
|
|
Eye disorders
Conjunctival disorder
|
0.00%
0/18 • Dispense through study completion, an average of 4 weeks
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."
|
0.00%
0/18 • Dispense through study completion, an average of 4 weeks
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."
|
0.00%
0/18 • Dispense through study completion, an average of 4 weeks
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."
|
5.3%
1/19 • Dispense through study completion, an average of 4 weeks
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."
|
5.3%
1/19 • Dispense through study completion, an average of 4 weeks
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."
|
0.00%
0/19 • Dispense through study completion, an average of 4 weeks
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."
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
- Publication restrictions are in place
Restriction type: OTHER