Trial Outcomes & Findings for Clinical Evaluation of Etafilcon A Contact Lenses Using a Novel Molding Process (NCT NCT03605303)
NCT ID: NCT03605303
Last Updated: 2019-08-28
Results Overview
Subjective assessment of comfort will be performed using the Contact Lens User ExperienceTM (CLUE) questionnaire. CLUE is a validated patient reported outcomes (PRO) questionnaire used to assess patient experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a US contact-lens wearing population between 18 and 65 years of age. CLUE composite scores are derived using Item Response Theory (IRT) and follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. A 5-point increase in an average CLUE score translates into 10% shift in the distribution of scores for the population of soft disposable contact lens wearers.
TERMINATED
NA
3 participants
1-Week Follow-up
2019-08-28
Participant Flow
On July 06, 2018 Johnson \& Johnson Vision terminated this study prematurely after lens testing revealed that the lens thickness in the mid-periphery of the lens were thinner than the lens design targets. As of this date only 3 subjects were enrolled at 1 site.
Participant milestones
| Measure |
Test/Control
Subjects that were radnomized to wear the Test lens during the period and the Control lens during the second period. Both study lens was was to be worn bilaterally for a period of 1-week each.
|
Control/Test
Subjects that were radnomized to wear the Control lens during the period and the Test lens during the second period. Both study lens was was to be worn bilaterally for a period of 1-week each.
|
|---|---|---|
|
Period 1
STARTED
|
2
|
1
|
|
Period 1
COMPLETED
|
0
|
0
|
|
Period 1
NOT COMPLETED
|
2
|
1
|
|
Period 2
STARTED
|
0
|
0
|
|
Period 2
COMPLETED
|
0
|
0
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Test/Control
Subjects that were radnomized to wear the Test lens during the period and the Control lens during the second period. Both study lens was was to be worn bilaterally for a period of 1-week each.
|
Control/Test
Subjects that were radnomized to wear the Control lens during the period and the Test lens during the second period. Both study lens was was to be worn bilaterally for a period of 1-week each.
|
|---|---|---|
|
Period 1
Study Terminated
|
2
|
1
|
Baseline Characteristics
Clinical Evaluation of Etafilcon A Contact Lenses Using a Novel Molding Process
Baseline characteristics by cohort
| Measure |
All Enrolled Subjects
n=3 Participants
All subjects enrolled into th study
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
White
|
1 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacfic Islander
|
1 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 1-Week Follow-upPopulation: Study terminated early. No data was analyzed.
Subjective assessment of comfort will be performed using the Contact Lens User ExperienceTM (CLUE) questionnaire. CLUE is a validated patient reported outcomes (PRO) questionnaire used to assess patient experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a US contact-lens wearing population between 18 and 65 years of age. CLUE composite scores are derived using Item Response Theory (IRT) and follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. A 5-point increase in an average CLUE score translates into 10% shift in the distribution of scores for the population of soft disposable contact lens wearers.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 1-Week Follow-upPopulation: Study terminated early. No data was analyzed.
Subjective assessment of vision will be performed using the Contact Lens User ExperienceTM (CLUE) questionnaire. CLUE is a validated patient reported outcomes (PRO) questionnaire used to assess patient experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a US contact-lens wearing population between 18 and 65 years of age. CLUE composite scores are derived using Item Response Theory (IRT) and follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. A 5-point increase in an average CLUE score translates into 10% shift in the distribution of scores for the population of soft disposable contact lens wearers.
Outcome measures
Outcome data not reported
Adverse Events
Test
Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Brian Pall OD, MS, FAAO - Director of Clinical Sciences
Johnson & Johnson Vision Care Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60