Trial Outcomes & Findings for Dispensing Evaluation of Investigational Contact Lenses (NCT NCT02625220)
NCT ID: NCT02625220
Last Updated: 2017-06-07
Results Overview
Monocular visual acuity was assessed using distance Snellen visual acuity. Visual Acuity data was dichotomized such that 'response=1' if a subjects has 20/40 or better and 'response=0' if subject has worse than 20/40. The proportion of eyes with 20/40 or better was reported.
COMPLETED
NA
177 participants
7 day follow-up
2017-06-07
Participant Flow
A total of 177 subjects were enrolled into this study. Of the enrolled subjects, 7 did not meet the eligibility criteria and 170 subjects were dispensed a study lens. Of the dispensed subjects, 7 were discontinued and 163 completed the study.
Participant milestones
| Measure |
Prototype Toric Lens Senofilcon A
All subjects in this study were dispensed the prototype toric lens senofilcon A in this study.
|
|---|---|
|
Overall Study
STARTED
|
170
|
|
Overall Study
COMPLETED
|
163
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
Prototype Toric Lens Senofilcon A
All subjects in this study were dispensed the prototype toric lens senofilcon A in this study.
|
|---|---|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Lost to Follow-up
|
2
|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
Study discontinued at site
|
2
|
Baseline Characteristics
Dispensing Evaluation of Investigational Contact Lenses
Baseline characteristics by cohort
| Measure |
Prototype Toric Lens Senofilcon A
n=170 Participants
All subjects in this study were dispensed the prototype toric lens senofilcon A in this study.
|
|---|---|
|
Age, Continuous
|
28.8 Years
STANDARD_DEVIATION 5.71 • n=99 Participants
|
|
Sex: Female, Male
Female
|
112 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
58 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
American Indian or Native Alaskian
|
4 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Asian
|
7 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
19 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
White
|
131 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Other
|
7 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
170 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 7 day follow-upPopulation: The analysis population consists of subjects that completed all study visits without a major protocol deviation (per-protocol). One subject was excluded from the analysis population due to a major protocol deviation.
Monocular visual acuity was assessed using distance Snellen visual acuity. Visual Acuity data was dichotomized such that 'response=1' if a subjects has 20/40 or better and 'response=0' if subject has worse than 20/40. The proportion of eyes with 20/40 or better was reported.
Outcome measures
| Measure |
Prototype Toric Lens Senofilcon A
n=324 Subject Eyes
All subjects in this study were dispensed the prototype toric lens senofilcon A in this study.
|
|---|---|
|
Proportion of Eyes With Monocular Visual Acuity Better Than 20/40
|
1.0 proportion of Subject Eyes
|
PRIMARY outcome
Timeframe: 15 Minutes Post InsertionPopulation: The analysis population consists of subjects that completed all study visits without a major protocol deviation (per-protocol). One subject was excluded from the analysis population due to a major protocol deviation.
Absolute rotation was measured using a slit lamp. Absolute rotation measured at 15-minute post insertion was categorized into a binary outcome as 'response=1' if the absolute rotation is less than or equal to 10 degrees or 'response=0' otherwise. The proportion of eyes with absolute rotation less than or equal to 10 degrees was reported.
Outcome measures
| Measure |
Prototype Toric Lens Senofilcon A
n=324 Subject Eyes
All subjects in this study were dispensed the prototype toric lens senofilcon A in this study.
|
|---|---|
|
The Proportion of Eyes With Absolute Rotation Less Than or Equal to 10 Degrees
|
0.993 proportion of Subject Eyes
|
PRIMARY outcome
Timeframe: 15 Minutes Post InsertionPopulation: The analysis population consists of subjects that completed all study visits without a major protocol deviation (per-protocol). One subject was excluded from the analysis population due to a major protocol deviation.
Lens stability with blink was measured using a slit lamp. The rotational stability of the lens during a series of normal (unforced) blinks was measured for both eyes. The data was dichotomized as 'response=1' if the lens stability was less than or equal to 5 degrees or 'response=0' otherwise. The proportion of eyes with rotational stability of 5 degrees or lower was reported.
Outcome measures
| Measure |
Prototype Toric Lens Senofilcon A
n=324 Subject Eyes
All subjects in this study were dispensed the prototype toric lens senofilcon A in this study.
|
|---|---|
|
Proportion of Subjects Eyes With Lens Stability With Blink Within 5 Degrees
|
1.0 proportion of Subject Eyes
|
PRIMARY outcome
Timeframe: 15 Minute Post InsertionPopulation: The analysis population consists of subjects that completed all study visits without a major protocol deviation (per-protocol). One subject was excluded from the analysis population due to a major protocol deviation.
Acceptability of contact lens fit was assessed via slit lamp and was reported as a binary response as Acceptable or Unacceptable. The proportion of eyes with acceptable fit was reported.
Outcome measures
| Measure |
Prototype Toric Lens Senofilcon A
n=324 Subject Eyes
All subjects in this study were dispensed the prototype toric lens senofilcon A in this study.
|
|---|---|
|
Proportion of Subject Eyes With Acceptable Lens Fit
|
1.0 proportion of Subject Eyes
|
Adverse Events
Prototype Toric Lens Senofilcon A
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Benjamin Straker, BAppSc(Optom)(HonS) Principal Research Optometrist
Johnson & Johnson Vision Care Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60