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Trial Outcomes & Findings for Two Week Cross-Over Study Comparing Two Daily Disposable Contact Lenses (NCT NCT01155323)

NCT ID: NCT01155323

Last Updated: 2018-06-19

Results Overview

This outcome is a weighted combined score calculated from individual comfort-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

118 participants

Primary outcome timeframe

after 1 week of lens wear

Results posted on

2018-06-19

Participant Flow

Participant milestones

Participant milestones
Measure
Etafilcon A/Omafilcon A
etafilcon A contact lenses will be worn first and omafilcon A contact lenses will be worn second.
Omafilcon A/Etafilcon A
omafilcon A contact lenses will be worn first and etafilcon A contact lenses will be worn second.
First Intervention
STARTED
60
58
First Intervention
COMPLETED
59
57
First Intervention
NOT COMPLETED
1
1
Second Intervention
STARTED
59
57
Second Intervention
COMPLETED
58
56
Second Intervention
NOT COMPLETED
1
1

Reasons for withdrawal

Reasons for withdrawal
Measure
Etafilcon A/Omafilcon A
etafilcon A contact lenses will be worn first and omafilcon A contact lenses will be worn second.
Omafilcon A/Etafilcon A
omafilcon A contact lenses will be worn first and etafilcon A contact lenses will be worn second.
First Intervention
exclusion criteria
1
1
Second Intervention
Lost to Follow-up
1
1

Baseline Characteristics

Two Week Cross-Over Study Comparing Two Daily Disposable Contact Lenses

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Total Number of Participants
n=113 Participants
This represents all subjects that completed the study minus one additional subject excluded due the discovery after study completion that the subject conflicted with exclusion criteria.
Age, Continuous
25.3 years
STANDARD_DEVIATION 4.4 • n=5 Participants
Sex: Female, Male
Female
80 Participants
n=5 Participants
Sex: Female, Male
Male
33 Participants
n=5 Participants
Region of Enrollment
Singapore
113 participants
n=5 Participants

PRIMARY outcome

Timeframe: after 1 week of lens wear

Population: The analysis population represents subjects that completed the study per protocol.

This outcome is a weighted combined score calculated from individual comfort-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response.

Outcome measures

Outcome measures
Measure
Etafilcon A
n=113 Participants
soft contact lens replaced daily, worn for one week.
Omafilcon A
n=113 Participants
soft contact lens replaced daily, worn for one week.
Subjective Rating of Comfort
3.33 Units on a scale
Standard Error 0.09
3.32 Units on a scale
Standard Error 0.09

PRIMARY outcome

Timeframe: after 1 week of lens wear

Population: The analysis population represents subjects that completed the study per protocol.

This outcome is a weighted combined score calculated from individual vision-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response.

Outcome measures

Outcome measures
Measure
Etafilcon A
n=113 Participants
soft contact lens replaced daily, worn for one week.
Omafilcon A
n=113 Participants
soft contact lens replaced daily, worn for one week.
Vision Quality
3.53 Units on a scale
Standard Error 0.08
3.50 Units on a scale
Standard Error 0.08

PRIMARY outcome

Timeframe: after 1 week of lens wear

Population: The analysis population represents subjects that completed the study per protocol.

This outcome is a weighted combined score calculated from individual lens handling-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response.

Outcome measures

Outcome measures
Measure
Etafilcon A
n=113 Participants
soft contact lens replaced daily, worn for one week.
Omafilcon A
n=113 Participants
soft contact lens replaced daily, worn for one week.
Subjective Rating of Handling
3.48 Units on a scale
Standard Error 0.09
3.48 Units on a scale
Standard Error 0.09

PRIMARY outcome

Timeframe: after 1 week of lens wear

Population: The analysis population represents subjects that completed the study per protocol.

Investigator assessment of the corneal staining. Staining is an indication of dryness on areas on the cornea. Here it is measured over 5 regions of the cornea: central, temporal, nasal, inferior, and superior. The staining is graded using the National Eye Institute (NEI)0-3 scale: grade 0 = normal, grade 1 = mild, grade 2 = moderate, grade 3 = severe.

Outcome measures

Outcome measures
Measure
Etafilcon A
n=113 Participants
soft contact lens replaced daily, worn for one week.
Omafilcon A
n=113 Participants
soft contact lens replaced daily, worn for one week.
Corneal Staining
0.07 Units on a scale
Standard Error 0.01
0.09 Units on a scale
Standard Error 0.01

PRIMARY outcome

Timeframe: after 1 week of lens wear

Population: The analysis population represents subjects that completed the study per protocol.

This outcome is a weighted combined score calculated from individual quality perception-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response.

Outcome measures

Outcome measures
Measure
Etafilcon A
n=113 Participants
soft contact lens replaced daily, worn for one week.
Omafilcon A
n=113 Participants
soft contact lens replaced daily, worn for one week.
Subjective Rating of Quality Perceptions
3.51 Units on a scale
Standard Error 0.08
3.44 Units on a scale
Standard Error 0.08

PRIMARY outcome

Timeframe: after 1 week of wear

Population: The analysis population represents subjects that completed the study per protocol.

This outcome is assessed by the investigator during biomicroscopy examination using the following 0-4 scale: 0 = none, 1 = trace, 2 = mild, 3= moderate, 4 = severe.

Outcome measures

Outcome measures
Measure
Etafilcon A
n=113 Participants
soft contact lens replaced daily, worn for one week.
Omafilcon A
n=113 Participants
soft contact lens replaced daily, worn for one week.
Limbal Hyperemia
0.51 Units on a scale
Standard Error 0.02
0.48 Units on a scale
Standard Error 0.02

Adverse Events

Etafilcon A

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

Omafilcon A

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

Wakana Katabami

Johnson and Johnson K.K.

Phone: 81-34411-8040

Results disclosure agreements

  • Principal investigator is a sponsor employee The results of the study may not be published or publicly presented without prior written approval of the sponsor. If the investigator wishes to publish or present any study findings, investigator shall contact sponsor to discuss publication plan.
  • Publication restrictions are in place

Restriction type: OTHER