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Trial Outcomes & Findings for Open Eye Corneal Swelling With Daily Disposable Contact Lenses and no Lens Wear (NCT NCT01765972)

NCT ID: NCT01765972

Last Updated: 2018-06-19

Results Overview

Central corneal thickness was measured at baseline and 8-hour post fit with a modified optical pachometer on a Zeiss biomicroscope, interfaced to a PC. The pachometry measurement included seven readings; the computer is programmed to remove the high and low readings and to calculate the average of the remaining five readings. Only a single central corneal thickness measurement, the average of the 5 readings, was recorded by the investigator in the eCRF. The average percent change from baseline of corneal swelling was reported and was calculated as: ((Post fit - Baseline)/ Baseline) X 100.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

39 participants

Primary outcome timeframe

8 hours post fit

Results posted on

2018-06-19

Participant Flow

A total of 39 subjects were enrolled in this study. Of those enrolled subjects 15 subjects did not meet the eligibility criteria. The remaining 24 subjects were successfully dispensed a study lens and completed the study.

Participant milestones

Participant milestones
Measure
Test 1/Spectacle/Test 2/ Test 3
Subjects received Test 1 (etafilcon A with Laceron) and then received spectacle and then received Test 2 (etafilcon A with print) and then received Test 3 (etafilcon A with print).
Test 2/ Test 3/ Spectacle/ Test 1
Subjects received Test 2 (etafilcon A with print) and then received Test 3 (etafilcon A with print) and then received spectacle and then received Test 1 (etafilcon A with Laceron).
Test 3/ Test 1/ Test 2/ Spectacle
Subjects received Test 3 (etafilcon A with print) and then received Test 1 (etafilcon A with Laceron) and then received Test 2 (etafilcon A with print) and then received spectacle.
Spectacle/ Test 2/ Test 1/ Test 3
Subjects received spectacle and then received Test 2 (etafilcon A with print) and then received Test 1 (etafilcon A with Laceron) and then received Test 3 (etafilcon A with print) .
Overall Study
STARTED
6
6
6
6
Overall Study
COMPLETED
6
6
6
6
Overall Study
NOT COMPLETED
0
0
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Open Eye Corneal Swelling With Daily Disposable Contact Lenses and no Lens Wear

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Overall
n=24 Participants
All subjects that were dispensed a study lens.
Age, Continuous
21.13 years
STANDARD_DEVIATION 2.437 • n=5 Participants
Sex: Female, Male
Female
19 Participants
n=5 Participants
Sex: Female, Male
Male
5 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
24 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=5 Participants
Race (NIH/OMB)
White
0 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Region of Enrollment
Canada
24 participants
n=5 Participants

PRIMARY outcome

Timeframe: 8 hours post fit

Population: Analysis population consists of subjects that completed all study visits without a major protocol deviation.

Central corneal thickness was measured at baseline and 8-hour post fit with a modified optical pachometer on a Zeiss biomicroscope, interfaced to a PC. The pachometry measurement included seven readings; the computer is programmed to remove the high and low readings and to calculate the average of the remaining five readings. Only a single central corneal thickness measurement, the average of the 5 readings, was recorded by the investigator in the eCRF. The average percent change from baseline of corneal swelling was reported and was calculated as: ((Post fit - Baseline)/ Baseline) X 100.

Outcome measures

Outcome measures
Measure
Test 1 (Etafilcon A With Lacreon)
n=24 Participants
Subjects that received Test 1 (etafilcon A with Lacreon) lens in any of the 4 periods of this study.
Test 2 (Etafilcon A With Lacreon With Print)
n=24 Participants
Subjects that received Test 2 (etafilcon A with Lacreon with print) lens in any of the 4 periods of this study.
Test 3 (Etafilcon A With Print)
n=24 Participants
Subjects that received Test 3 (etafilcon A with print) lens in any of the 4 periods of this study.
Spectacle
n=24 Participants
Subjects that wore spectacles in any of the 4 periods of this study.
Percentage Change From Baseline of Corneal Swelling 8 Hours Post Fit
0.07 percentage of change from baseline
Standard Deviation 0.288
-0.02 percentage of change from baseline
Standard Deviation 0.286
0.14 percentage of change from baseline
Standard Deviation 0.350
-0.06 percentage of change from baseline
Standard Deviation 0.293

Adverse Events

Spectacle

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Test 1 (Etafilcon A With Lacreon)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Test 2 (Etafilcon A With Lacreon With Print)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Test 3 (Etafilcon A With Print)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Katherine Osborn Lorenz, OD, MS

Johnson & Johnson Vision Care Inc.

Phone: 614 459-9477

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place

Restriction type: GT60