Trial Outcomes & Findings for Clinical and Laboratory Evaluation of 3 Contact Lenses With 4 Contact Lens Solutions (NCT NCT01791517)

Last Updated: 2018-06-19

Results Overview

CLUE overall comfort is assessed using the Contact Lens User Experience (CLUE)TM questionnaire for the senofilcon A lens only. CLUE is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3XSD).

Recruitment status

COMPLETED

Study phase

Target enrollment

269 participants

Primary outcome timeframe

2-Week Follow-up

Results posted on

2018-06-19

Participant Flow

A total of 269 Subjects were enrolled into this study. Of the enrolled 33 subjects did not meet the eligibility criteria. In Phase I 28 subjects were discontinued and 208 subjects completed Phase I. Of the 208 subjects that continued into Phase II 187 subjects completed the study and 21 subjects were discontinued from the from Phase II.

Subjects were first randomized to 1 of 3 lenses(Lens A: senofilcon A, Lens B: galyfilcon A, Lens C: etafilcon A), then within each lens subjects were randomized to 1 of 12 unique solution sequences, totaling in 36 sequences. Due to such a large number of sequences for reporting purposes, subject disposition is reported by solution and period.

Participant milestones

Participant milestones
Measure	Biotrue/PureMoist/Revitalens/Clear Care Subjects were first randomized to receive to one of three lenses lens. For Phase I subjects were then further randomized to one of twelve unique solution sequences.	Biotrue/RevitaLens/Clear Care/PureMoist Subjects were first randomized to receive to one of three lenses lens. For Phase I subjects were then further randomized to one of twelve unique solution sequences.	Biotrue/Clear Care/PureMoist/RevitaLens Subjects were first randomized to receive to one of three lenses lens. For Phase I subjects were then further randomized to one of twelve unique solution sequences.	PureMoist/Biotrue/Clear Care/RevitaLens Subjects were first randomized to receive to one of three lenses lens. For Phase I subjects were then further randomized to one of twelve unique solution sequences.	PureMoist/RevitaLens/Biotrue/Clear Care Subjects were first randomized to receive to one of three lenses lens. For Phase I subjects were then further randomized to one of twelve unique solution sequences.	PureMoist/Clear Care/RevitaLens/Biotrue Subjects were first randomized to receive to one of three lenses lens. For Phase I subjects were then further randomized to one of twelve unique solution sequences.	RevitaLens/Biotrue/PureMoist/Clear Care Subjects were first randomized to receive to one of three lenses lens. For Phase I subjects were then further randomized to one of twelve unique solution sequences.	RevitaLens/PureMoist/Clear Care/Biotrue Subjects were first randomized to receive to one of three lenses lens. For Phase I subjects were then further randomized to one of twelve unique solution sequences.	RevitaLens/Clear Care/Biotrue/PureMoist Subjects were first randomized to receive to one of three lenses lens. For Phase I subjects were then further randomized to one of twelve unique solution sequences.	Clear Care/Biotrue/RevitaLens/PureMoist Subjects were first randomized to receive to one of three lenses lens. For Phase I subjects were then further randomized to one of twelve unique solution sequences.	Clear Care/PureMoist/Biotrue/RevitaLens Subjects were first randomized to receive to one of three lenses lens. For Phase I subjects were then further randomized to one of twelve unique solution sequences.	Clear Care/RevitaLens/PureMoist/Biotrue Subjects were first randomized to receive to one of three lenses lens. For Phase I subjects were then further randomized to one of twelve unique solution sequences.
Phase I: Period 1 STARTED	19	20	20	19	20	20	20	20	20	20	18	20
Phase I: Period 1 COMPLETED	18	18	18	17	19	19	19	20	19	19	18	19
Phase I: Period 1 NOT COMPLETED	1	2	2	2	1	1	1	0	1	1	0	1
Phase I: Period 2 STARTED	18	18	18	17	19	19	19	20	19	19	18	19
Phase I: Period 2 COMPLETED	17	15	16	16	19	18	19	20	19	18	16	19
Phase I: Period 2 NOT COMPLETED	1	3	2	1	0	1	0	0	0	1	2	0
Phase I: Period 3 STARTED	17	15	16	16	19	18	19	20	19	18	16	19
Phase I: Period 3 COMPLETED	17	14	16	15	18	18	19	20	19	18	16	18
Phase I: Period 3 NOT COMPLETED	0	1	0	1	1	0	0	0	0	0	0	1
Phase I: Period 4 STARTED	17	14	16	15	18	18	19	20	19	18	16	18
Phase I: Period 4 COMPLETED	17	14	16	15	18	18	19	20	19	18	16	18
Phase I: Period 4 NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0
Phase II STARTED	17	14	16	15	18	18	19	20	19	18	16	18
Phase II COMPLETED	15	14	15	15	16	14	17	17	17	15	15	17
Phase II NOT COMPLETED	2	0	1	0	2	4	2	3	2	3	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Biotrue/PureMoist/Revitalens/Clear Care Subjects were first randomized to receive to one of three lenses lens. For Phase I subjects were then further randomized to one of twelve unique solution sequences.	Biotrue/RevitaLens/Clear Care/PureMoist Subjects were first randomized to receive to one of three lenses lens. For Phase I subjects were then further randomized to one of twelve unique solution sequences.	Biotrue/Clear Care/PureMoist/RevitaLens Subjects were first randomized to receive to one of three lenses lens. For Phase I subjects were then further randomized to one of twelve unique solution sequences.	PureMoist/Biotrue/Clear Care/RevitaLens Subjects were first randomized to receive to one of three lenses lens. For Phase I subjects were then further randomized to one of twelve unique solution sequences.	PureMoist/RevitaLens/Biotrue/Clear Care Subjects were first randomized to receive to one of three lenses lens. For Phase I subjects were then further randomized to one of twelve unique solution sequences.	PureMoist/Clear Care/RevitaLens/Biotrue Subjects were first randomized to receive to one of three lenses lens. For Phase I subjects were then further randomized to one of twelve unique solution sequences.	RevitaLens/Biotrue/PureMoist/Clear Care Subjects were first randomized to receive to one of three lenses lens. For Phase I subjects were then further randomized to one of twelve unique solution sequences.	RevitaLens/PureMoist/Clear Care/Biotrue Subjects were first randomized to receive to one of three lenses lens. For Phase I subjects were then further randomized to one of twelve unique solution sequences.	RevitaLens/Clear Care/Biotrue/PureMoist Subjects were first randomized to receive to one of three lenses lens. For Phase I subjects were then further randomized to one of twelve unique solution sequences.	Clear Care/Biotrue/RevitaLens/PureMoist Subjects were first randomized to receive to one of three lenses lens. For Phase I subjects were then further randomized to one of twelve unique solution sequences.	Clear Care/PureMoist/Biotrue/RevitaLens Subjects were first randomized to receive to one of three lenses lens. For Phase I subjects were then further randomized to one of twelve unique solution sequences.	Clear Care/RevitaLens/PureMoist/Biotrue Subjects were first randomized to receive to one of three lenses lens. For Phase I subjects were then further randomized to one of twelve unique solution sequences.
Phase I: Period 1 Withdrawal by Subject	0	1	1	0	1	1	0	0	0	0	0	0
Phase I: Period 1 Adverse Event	0	0	1	1	0	0	0	0	0	0	0	0
Phase I: Period 1 Unsatisfactory Lens Fitting	1	0	0	0	0	0	0	0	0	0	0	0
Phase I: Period 1 Protocol Violation	0	1	0	0	0	0	0	0	0	0	0	0
Phase I: Period 1 Lost to Follow-up	0	0	0	1	0	0	1	0	1	1	0	0
Phase I: Period 1 Lens Handling DIfficulties	0	0	0	0	0	0	0	0	0	0	0	1
Phase I: Period 2 Unsatisfactory Lens Fit	1	0	0	0	0	0	0	0	0	0	0	0
Phase I: Period 2 Protocol Violation	0	0	0	1	0	0	0	0	0	0	0	0
Phase I: Period 2 Withdrawal by Subject	0	0	0	0	0	0	0	0	0	1	1	0
Phase I: Period 2 Unsatisfactory Visual Response	0	0	0	0	0	0	0	0	0	0	1	0
Phase I: Period 2 Lens Discomfort	0	0	0	0	0	1	0	0	0	0	0	0
Phase I: Period 2 Lost to Follow-up	0	3	2	0	0	0	0	0	0	0	0	0
Phase I: Period 3 Lens Discomfort	0	0	0	0	0	0	0	0	0	0	0	1
Phase I: Period 3 Lost to Follow-up	0	1	0	0	1	0	0	0	0	0	0	0
Phase I: Period 3 Adverse Event	0	0	0	1	0	0	0	0	0	0	0	0
Phase II Lost to Follow-up	1	0	1	0	1	2	0	1	1	1	0	0
Phase II Withdrawal by Subject	1	0	0	0	0	2	0	1	0	0	1	0
Phase II Lack of Efficacy	0	0	0	0	1	0	0	0	0	0	0	0
Phase II Adverse Event	0	0	0	0	0	0	2	1	0	1	0	0
Phase II Lens Handling Difficulties	0	0	0	0	0	0	0	0	1	0	0	0
Phase II Unsatisfactory Lens Fitting	0	0	0	0	0	0	0	0	0	1	0	0
Phase II Pre-Existing Ocular Issue	0	0	0	0	0	0	0	0	0	0	0	1

Baseline Characteristics

Clinical and Laboratory Evaluation of 3 Contact Lenses With 4 Contact Lens Solutions

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Etafilcon A n=80 Participants All subjects that were randomized to the study lens etafilcon A and 1 of 12 possible solution sequences.	Galyfilcon A n=78 Participants All subjects that were randomized to the study lens galyfilcon A and 1 of 12 possible solution sequences.	Senofilcon A n=78 Participants All subjects that were randomized to the study lens senofilcon A and 1 of 12 possible solution sequences.	Total n=236 Participants Total of all reporting groups
Age, Continuous	30.33 years STANDARD_DEVIATION 9.726 • n=99 Participants	30.38 years STANDARD_DEVIATION 10.091 • n=107 Participants	29.78 years STANDARD_DEVIATION 9.938 • n=206 Participants	30.17 years STANDARD_DEVIATION 9.879 • n=7 Participants
Sex: Female, Male Female	55 Participants n=99 Participants	50 Participants n=107 Participants	53 Participants n=206 Participants	158 Participants n=7 Participants
Sex: Female, Male Male	25 Participants n=99 Participants	28 Participants n=107 Participants	25 Participants n=206 Participants	78 Participants n=7 Participants
Race/Ethnicity, Customized Asian	18 Participants n=99 Participants	18 Participants n=107 Participants	22 Participants n=206 Participants	58 Participants n=7 Participants
Race/Ethnicity, Customized Black or African American	9 Participants n=99 Participants	5 Participants n=107 Participants	6 Participants n=206 Participants	20 Participants n=7 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants	1 Participants n=7 Participants
Race/Ethnicity, Customized White	52 Participants n=99 Participants	45 Participants n=107 Participants	43 Participants n=206 Participants	140 Participants n=7 Participants
Race/Ethnicity, Customized Other	1 Participants n=99 Participants	10 Participants n=107 Participants	6 Participants n=206 Participants	17 Participants n=7 Participants
Region of Enrollment Canada	28 Participants n=99 Participants	26 Participants n=107 Participants	26 Participants n=206 Participants	80 Participants n=7 Participants
Region of Enrollment United States	26 Participants n=99 Participants	24 Participants n=107 Participants	27 Participants n=206 Participants	77 Participants n=7 Participants
Region of Enrollment United Kingdom	26 Participants n=99 Participants	28 Participants n=107 Participants	25 Participants n=206 Participants	79 Participants n=7 Participants

PRIMARY outcome

Timeframe: 2-Week Follow-up

Population: The analysis population consists of all subjects that have completed all study visits without a major protocol deviation. The number of subjects reported above is the maximum number of subjects for that solution. The number of subjects may vary per solution/lens combination, since this study was stratified by contact lens.

Outcome measures

Outcome measures
Measure	Solution 1(RevitaLens) n=69 Participants Subjects that received solution 1 during any of the 4 study periods.	Solution 2(PureMoist) n=69 Participants Subjects that received solution 2 during any of the 4 study periods.	Solution 3(Biotrue) n=69 Participants Subjects that received solution 3 during any of the 4 study periods.	Solution 4(Clear Care) n=69 Participants Subjects that received solution 4 during any of the 4 study periods.
Overall Comfort Score (Senofilcon A Lens)	64.42 units on a scale Standard Deviation 22.536	59.73 units on a scale Standard Deviation 25.470	63.75 units on a scale Standard Deviation 21.796	63.47 units on a scale Standard Deviation 23.739

PRIMARY outcome

Timeframe: 2-Week Follow-up

CLUE overall comfort is assessed using the Contact Lens User Experience (CLUE)TM questionnaire for the galyfilcon A lens only. CLUE is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3XSD).

Outcome measures

Outcome measures
Measure	Solution 1(RevitaLens) n=69 Participants Subjects that received solution 1 during any of the 4 study periods.	Solution 2(PureMoist) n=69 Participants Subjects that received solution 2 during any of the 4 study periods.	Solution 3(Biotrue) n=69 Participants Subjects that received solution 3 during any of the 4 study periods.	Solution 4(Clear Care) n=69 Participants Subjects that received solution 4 during any of the 4 study periods.
Overall Comfort Score (Galyfilcon A Lens)	59.79 units on a scale Standard Deviation 23.430	56.95 units on a scale Standard Deviation 24.679	58.52 units on a scale Standard Deviation 22.197	59.83 units on a scale Standard Deviation 22.437

PRIMARY outcome

Timeframe: 2-Week Follow-up

CLUE overall comfort is assessed using the Contact Lens User Experience (CLUE)TM questionnaire for the etafilcon A lens only. CLUE is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3XSD).

Outcome measures

Outcome measures
Measure	Solution 1(RevitaLens) n=65 Participants Subjects that received solution 1 during any of the 4 study periods.	Solution 2(PureMoist) n=65 Participants Subjects that received solution 2 during any of the 4 study periods.	Solution 3(Biotrue) n=65 Participants Subjects that received solution 3 during any of the 4 study periods.	Solution 4(Clear Care) n=65 Participants Subjects that received solution 4 during any of the 4 study periods.
Overall Comfort Score (Etafilcon A Lens)	62.57 units on a scale Standard Deviation 25.158	67.44 units on a scale Standard Deviation 19.65	62.43 units on a scale Standard Deviation 21.492	65.33 units on a scale Standard Deviation 21.163

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Solution 1(RevitaLens): Senofilcon A n=78 participants at risk Subjects that were randomized to the senofilcon A lens and received solution 1 during any of the 4 study periods.	Solution 1 (RevitaLens): Galyfilcon A n=78 participants at risk Subjects that were randomized to the galyfilcon A lens and received solution 1 during any of the 4 study periods.	Solution 1(RevitaLens): Etafilcon A n=80 participants at risk Subjects that were randomized to the etafilcon A lens and received solution 1 during any of the 4 study periods.	Solution 2(PureMoist):Senofilcon A n=78 participants at risk Subjects were randomized to the senofilcon A lens and that received solution 2 during any of the 4 study periods.	Solution 2(PureMoist): Galyfilcon A n=78 participants at risk Subjects were randomized to the galyfilcon A lens and that received solution 2 during any of the 4 study periods.	Solution 2(PureMoist): Etafilcon A n=80 participants at risk Subjects were randomized to the etafilcon A lens and that received solution 2 during any of the 4 study periods.	Solution 3(Biotrue): Senofilcon A n=78 participants at risk Subjects that were randomized to the senofilcon A lens and received solution 3 during any of the 4 study periods.	Solution 3(Biotrue): Galyfilcon A n=78 participants at risk Subjects that were randomized to the galyfilcon A lens and received solution 3 during any of the 4 study periods.	Solution 3(Biotrue): Etafilcon A n=80 participants at risk Subjects that were randomized to the etafilcon A lens and received solution 3 during any of the 4 study periods.	Solution 4(Clear Care): Senofilcon A n=78 participants at risk Subjects that were randomized to the senofilcon A lens and received solution 4 during any of the 4 study periods.	Solution 4(Clear Care): Galyfilcon A n=78 participants at risk Subjects that were randomized to the galyfilcon A lens and received solution 4 during any of the 4 study periods.	Solution 4(Clear Care): Etafilcon A n=80 participants at risk Subjects that were randomized to the etafilcon A lens and received solution 4 during any of the 4 study periods.
Infections and infestations Retro-peritoneal abscess in the kidney area.	1.3% 1/78 • Number of events 1 • Throughout the duration of the study. Approximately 52 weeks. Adverse events from Phase I and Phase II are reported together due to the large number of lens and solution combinations.	0.00% 0/78 • Throughout the duration of the study. Approximately 52 weeks. Adverse events from Phase I and Phase II are reported together due to the large number of lens and solution combinations.	0.00% 0/80 • Throughout the duration of the study. Approximately 52 weeks. Adverse events from Phase I and Phase II are reported together due to the large number of lens and solution combinations.	0.00% 0/78 • Throughout the duration of the study. Approximately 52 weeks. Adverse events from Phase I and Phase II are reported together due to the large number of lens and solution combinations.	0.00% 0/78 • Throughout the duration of the study. Approximately 52 weeks. Adverse events from Phase I and Phase II are reported together due to the large number of lens and solution combinations.	0.00% 0/80 • Throughout the duration of the study. Approximately 52 weeks. Adverse events from Phase I and Phase II are reported together due to the large number of lens and solution combinations.	0.00% 0/78 • Throughout the duration of the study. Approximately 52 weeks. Adverse events from Phase I and Phase II are reported together due to the large number of lens and solution combinations.	0.00% 0/78 • Throughout the duration of the study. Approximately 52 weeks. Adverse events from Phase I and Phase II are reported together due to the large number of lens and solution combinations.	0.00% 0/80 • Throughout the duration of the study. Approximately 52 weeks. Adverse events from Phase I and Phase II are reported together due to the large number of lens and solution combinations.	0.00% 0/78 • Throughout the duration of the study. Approximately 52 weeks. Adverse events from Phase I and Phase II are reported together due to the large number of lens and solution combinations.	0.00% 0/78 • Throughout the duration of the study. Approximately 52 weeks. Adverse events from Phase I and Phase II are reported together due to the large number of lens and solution combinations.	0.00% 0/80 • Throughout the duration of the study. Approximately 52 weeks. Adverse events from Phase I and Phase II are reported together due to the large number of lens and solution combinations.
Nervous system disorders Seizure	0.00% 0/78 • Throughout the duration of the study. Approximately 52 weeks. Adverse events from Phase I and Phase II are reported together due to the large number of lens and solution combinations.	0.00% 0/78 • Throughout the duration of the study. Approximately 52 weeks. Adverse events from Phase I and Phase II are reported together due to the large number of lens and solution combinations.	0.00% 0/80 • Throughout the duration of the study. Approximately 52 weeks. Adverse events from Phase I and Phase II are reported together due to the large number of lens and solution combinations.	0.00% 0/78 • Throughout the duration of the study. Approximately 52 weeks. Adverse events from Phase I and Phase II are reported together due to the large number of lens and solution combinations.	0.00% 0/78 • Throughout the duration of the study. Approximately 52 weeks. Adverse events from Phase I and Phase II are reported together due to the large number of lens and solution combinations.	0.00% 0/80 • Throughout the duration of the study. Approximately 52 weeks. Adverse events from Phase I and Phase II are reported together due to the large number of lens and solution combinations.	0.00% 0/78 • Throughout the duration of the study. Approximately 52 weeks. Adverse events from Phase I and Phase II are reported together due to the large number of lens and solution combinations.	0.00% 0/78 • Throughout the duration of the study. Approximately 52 weeks. Adverse events from Phase I and Phase II are reported together due to the large number of lens and solution combinations.	1.2% 1/80 • Number of events 2 • Throughout the duration of the study. Approximately 52 weeks. Adverse events from Phase I and Phase II are reported together due to the large number of lens and solution combinations.	0.00% 0/78 • Throughout the duration of the study. Approximately 52 weeks. Adverse events from Phase I and Phase II are reported together due to the large number of lens and solution combinations.	0.00% 0/78 • Throughout the duration of the study. Approximately 52 weeks. Adverse events from Phase I and Phase II are reported together due to the large number of lens and solution combinations.	0.00% 0/80 • Throughout the duration of the study. Approximately 52 weeks. Adverse events from Phase I and Phase II are reported together due to the large number of lens and solution combinations.
Psychiatric disorders Mental Health / Phychiatric Hospital Admission	0.00% 0/78 • Throughout the duration of the study. Approximately 52 weeks. Adverse events from Phase I and Phase II are reported together due to the large number of lens and solution combinations.	0.00% 0/78 • Throughout the duration of the study. Approximately 52 weeks. Adverse events from Phase I and Phase II are reported together due to the large number of lens and solution combinations.	0.00% 0/80 • Throughout the duration of the study. Approximately 52 weeks. Adverse events from Phase I and Phase II are reported together due to the large number of lens and solution combinations.	0.00% 0/78 • Throughout the duration of the study. Approximately 52 weeks. Adverse events from Phase I and Phase II are reported together due to the large number of lens and solution combinations.	0.00% 0/78 • Throughout the duration of the study. Approximately 52 weeks. Adverse events from Phase I and Phase II are reported together due to the large number of lens and solution combinations.	0.00% 0/80 • Throughout the duration of the study. Approximately 52 weeks. Adverse events from Phase I and Phase II are reported together due to the large number of lens and solution combinations.	0.00% 0/78 • Throughout the duration of the study. Approximately 52 weeks. Adverse events from Phase I and Phase II are reported together due to the large number of lens and solution combinations.	0.00% 0/78 • Throughout the duration of the study. Approximately 52 weeks. Adverse events from Phase I and Phase II are reported together due to the large number of lens and solution combinations.	1.2% 1/80 • Number of events 1 • Throughout the duration of the study. Approximately 52 weeks. Adverse events from Phase I and Phase II are reported together due to the large number of lens and solution combinations.	0.00% 0/78 • Throughout the duration of the study. Approximately 52 weeks. Adverse events from Phase I and Phase II are reported together due to the large number of lens and solution combinations.	0.00% 0/78 • Throughout the duration of the study. Approximately 52 weeks. Adverse events from Phase I and Phase II are reported together due to the large number of lens and solution combinations.	0.00% 0/80 • Throughout the duration of the study. Approximately 52 weeks. Adverse events from Phase I and Phase II are reported together due to the large number of lens and solution combinations.
Surgical and medical procedures Reconstructive Surgery on Left Upper Arm	0.00% 0/78 • Throughout the duration of the study. Approximately 52 weeks. Adverse events from Phase I and Phase II are reported together due to the large number of lens and solution combinations.	0.00% 0/78 • Throughout the duration of the study. Approximately 52 weeks. Adverse events from Phase I and Phase II are reported together due to the large number of lens and solution combinations.	0.00% 0/80 • Throughout the duration of the study. Approximately 52 weeks. Adverse events from Phase I and Phase II are reported together due to the large number of lens and solution combinations.	0.00% 0/78 • Throughout the duration of the study. Approximately 52 weeks. Adverse events from Phase I and Phase II are reported together due to the large number of lens and solution combinations.	0.00% 0/78 • Throughout the duration of the study. Approximately 52 weeks. Adverse events from Phase I and Phase II are reported together due to the large number of lens and solution combinations.	0.00% 0/80 • Throughout the duration of the study. Approximately 52 weeks. Adverse events from Phase I and Phase II are reported together due to the large number of lens and solution combinations.	0.00% 0/78 • Throughout the duration of the study. Approximately 52 weeks. Adverse events from Phase I and Phase II are reported together due to the large number of lens and solution combinations.	0.00% 0/78 • Throughout the duration of the study. Approximately 52 weeks. Adverse events from Phase I and Phase II are reported together due to the large number of lens and solution combinations.	0.00% 0/80 • Throughout the duration of the study. Approximately 52 weeks. Adverse events from Phase I and Phase II are reported together due to the large number of lens and solution combinations.	1.3% 1/78 • Number of events 1 • Throughout the duration of the study. Approximately 52 weeks. Adverse events from Phase I and Phase II are reported together due to the large number of lens and solution combinations.	0.00% 0/78 • Throughout the duration of the study. Approximately 52 weeks. Adverse events from Phase I and Phase II are reported together due to the large number of lens and solution combinations.	0.00% 0/80 • Throughout the duration of the study. Approximately 52 weeks. Adverse events from Phase I and Phase II are reported together due to the large number of lens and solution combinations.
Infections and infestations Viral Meningitis	0.00% 0/78 • Throughout the duration of the study. Approximately 52 weeks. Adverse events from Phase I and Phase II are reported together due to the large number of lens and solution combinations.	0.00% 0/78 • Throughout the duration of the study. Approximately 52 weeks. Adverse events from Phase I and Phase II are reported together due to the large number of lens and solution combinations.	0.00% 0/80 • Throughout the duration of the study. Approximately 52 weeks. Adverse events from Phase I and Phase II are reported together due to the large number of lens and solution combinations.	0.00% 0/78 • Throughout the duration of the study. Approximately 52 weeks. Adverse events from Phase I and Phase II are reported together due to the large number of lens and solution combinations.	0.00% 0/78 • Throughout the duration of the study. Approximately 52 weeks. Adverse events from Phase I and Phase II are reported together due to the large number of lens and solution combinations.	0.00% 0/80 • Throughout the duration of the study. Approximately 52 weeks. Adverse events from Phase I and Phase II are reported together due to the large number of lens and solution combinations.	1.3% 1/78 • Number of events 1 • Throughout the duration of the study. Approximately 52 weeks. Adverse events from Phase I and Phase II are reported together due to the large number of lens and solution combinations.	0.00% 0/78 • Throughout the duration of the study. Approximately 52 weeks. Adverse events from Phase I and Phase II are reported together due to the large number of lens and solution combinations.	0.00% 0/80 • Throughout the duration of the study. Approximately 52 weeks. Adverse events from Phase I and Phase II are reported together due to the large number of lens and solution combinations.	0.00% 0/78 • Throughout the duration of the study. Approximately 52 weeks. Adverse events from Phase I and Phase II are reported together due to the large number of lens and solution combinations.	0.00% 0/78 • Throughout the duration of the study. Approximately 52 weeks. Adverse events from Phase I and Phase II are reported together due to the large number of lens and solution combinations.	0.00% 0/80 • Throughout the duration of the study. Approximately 52 weeks. Adverse events from Phase I and Phase II are reported together due to the large number of lens and solution combinations.

Other adverse events

Adverse event data not reported

Additional Information

Chantal Coles-Brennan, PRINCIPAL RESEARCH OPTOMETRIST, Global Med Affairs

Johnson & Johnson Vision Care, Inc.

Phone: 904-443-3500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60