Trial Outcomes & Findings for Study of ACUVUE® ADVANCE® PLUS Contact Lenses. (NCT NCT01244893)

Results Overview

Snellen VA was measured to the nearest letter then converted to the logMAR scale for the analysis. Values \< 0 imply a clinically positive result; while values \> 0 infer a clinically negative result.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

44 participants

Primary outcome timeframe

6-8 days after lens wear

Results posted on

2018-06-19

Participant Flow

4 investigation sites were used within the U.S. for this study, with a study duration of Oct 23, 2010 to Nov 7, 2010.

44 subjects enrolled; 42 completed as cohort, two subjects were discontinued.

Participant milestones

Participant milestones
Measure	Acuvue Advance Plus preQ/Acuvue Advance Plus postQ Arm 1: Acuvue Advance Plus silicone hydrogel contact lens manufactured prior to qualification were worn first, then Acuvue AdvancePlus silicone hydrogel contact lens manufactured after qualification were worn second. Arm 2: Acuvue AdvancePlus silicone hydrogel contact lens manufactured after qualification were worn first, then Acuvue Advance Plus silicone hydrogel contact lens manufactured prior to qualification were worn second.	Acuvue Advance Plus postQ/Acuvue Advance Plus preQ Arm 1: Acuvue Advance Plus silicone hydrogel contact lens manufactured prior to qualification will be worn first, then Acuvue AdvancePlus silicone hydrogel contact lens manufactured after qualification will be worn second. Arm 2: Acuvue AdvancePlus silicone hydrogel contact lens manufactured after qualification will be worn first, then Acuvue Advance Plus silicone hydrogel contact lens manufactured prior to qualification will be worn second.
Baseline STARTED	22	22
Baseline COMPLETED	22	21
Baseline NOT COMPLETED	0	1
1-Week Follow Up STARTED	22	21
1-Week Follow Up COMPLETED	21	21
1-Week Follow Up NOT COMPLETED	1	0
Final Visit STARTED	21	21
Final Visit COMPLETED	21	21
Final Visit NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Acuvue Advance Plus preQ/Acuvue Advance Plus postQ Arm 1: Acuvue Advance Plus silicone hydrogel contact lens manufactured prior to qualification were worn first, then Acuvue AdvancePlus silicone hydrogel contact lens manufactured after qualification were worn second. Arm 2: Acuvue AdvancePlus silicone hydrogel contact lens manufactured after qualification were worn first, then Acuvue Advance Plus silicone hydrogel contact lens manufactured prior to qualification were worn second.	Acuvue Advance Plus postQ/Acuvue Advance Plus preQ Arm 1: Acuvue Advance Plus silicone hydrogel contact lens manufactured prior to qualification will be worn first, then Acuvue AdvancePlus silicone hydrogel contact lens manufactured after qualification will be worn second. Arm 2: Acuvue AdvancePlus silicone hydrogel contact lens manufactured after qualification will be worn first, then Acuvue Advance Plus silicone hydrogel contact lens manufactured prior to qualification will be worn second.
Baseline Protocol Violation	0	1
1-Week Follow Up Lost to Follow-up	1	0

Baseline Characteristics

Study of ACUVUE® ADVANCE® PLUS Contact Lenses.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Subjects n=44 Participants Acuvue Advance Plus silicone hydrogel contact lens manufactured prior to qualification were worn first and Acuvue AdvancePlus silicone hydrogel contact lens manufactured after qualification were worn second.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	44 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	28.3 years STANDARD_DEVIATION 5.66 • n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants
Region of Enrollment United States	44 participants n=5 Participants

PRIMARY outcome

Timeframe: 6-8 days after lens wear

Population: Population analyzed are those who were enrolled, randomized, and completed the study.

Snellen VA was measured to the nearest letter then converted to the logMAR scale for the analysis. Values \< 0 imply a clinically positive result; while values \> 0 infer a clinically negative result.

Outcome measures

Outcome measures
Measure	Acuvue Advance Plus preQ n=42 Participants Acuvue Advance Plus silicone hydrogel contact lens manufactured prior to qualification were worn daily for 6-8 days. Binocular measurements reported only.	Acuvue Advance Plus postQ n=42 Participants Acuvue Advance Plus silicone hydrogel contact lens manufactured post qualification were worn daily for 6-8 days. Binocular measurements reported only.
Visual Acuity (VA)	-0.088 logMAR scale Standard Deviation 0.0328	-0.083 logMAR scale Standard Deviation 0.0377

SECONDARY outcome

Timeframe: 6-8 days after lens wear

Population: Population analyzed are those who were enrolled, randomized, and completed the study.

Corneal staining type was assessed by Investigator using a slit lamp and graded on a 5-point scale; 0=none, 1=trace, 2=mild, 3=moderate, 4=severe.

Outcome measures

Outcome measures
Measure	Acuvue Advance Plus preQ n=74 eyes Acuvue Advance Plus silicone hydrogel contact lens manufactured prior to qualification were worn daily for 6-8 days. Binocular measurements reported only.	Acuvue Advance Plus postQ n=78 eyes Acuvue Advance Plus silicone hydrogel contact lens manufactured post qualification were worn daily for 6-8 days. Binocular measurements reported only.
Corneal Staining	0.23 units on a scale Standard Deviation 0.424	0.17 units on a scale Standard Deviation 0.375

SECONDARY outcome

Timeframe: 6-8 days after lens wear

Population: Population analyzed are those who were enrolled, randomized, and completed the study.

Limbal redness was assessed by using a 5-point scale: 0=none, 1=trace, 2=mild, 3=moderate, 4=severe.

Outcome measures

Outcome measures
Measure	Acuvue Advance Plus preQ n=42 Participants Acuvue Advance Plus silicone hydrogel contact lens manufactured prior to qualification were worn daily for 6-8 days. Binocular measurements reported only.	Acuvue Advance Plus postQ n=42 Participants Acuvue Advance Plus silicone hydrogel contact lens manufactured post qualification were worn daily for 6-8 days. Binocular measurements reported only.
Limbal Redness	0.71 units on a scale Standard Deviation 0.457	0.79 units on a scale Standard Deviation 0.682

SECONDARY outcome

Timeframe: 6-8 days after lens wear

Population: Population analyzed consisted of those who were enrolled, randomized, and completed the study.

Scale of 0 increasing to 4. 0=None, 4=Severe Redness

Outcome measures

Outcome measures
Measure	Acuvue Advance Plus preQ n=42 Participants Acuvue Advance Plus silicone hydrogel contact lens manufactured prior to qualification were worn daily for 6-8 days. Binocular measurements reported only.	Acuvue Advance Plus postQ n=42 Participants Acuvue Advance Plus silicone hydrogel contact lens manufactured post qualification were worn daily for 6-8 days. Binocular measurements reported only.
Bulbar Redness	0.71 units on a scale Standard Deviation 0.673	0.71 units on a scale Standard Deviation 0.596

Adverse Events

AAP PreQ

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

AAP PostQ

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

Brian Pall, O.D., M.S., F.A.A.O. Senior Research Optometrist

Johnson & Johnson Vision Care

Phone: (904) 443-1290

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place