Trial Outcomes & Findings for Clinical Study of Approved and Investigational Contact Lenses (NCT NCT02708524)

Results Overview

Subjective Overall Comfort was evaluated using the Contact Lens User Experience Comfort scores (CLUE). CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.Range is 0 to 120. CLUE was collect at Baseline, Post Lens Fit 1-, 2-, 3- and 4- week follow-ups.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

554 participants

Primary outcome timeframe

Up to 1 month Follow-up

Results posted on

2016-11-09

Participant Flow

A total of 554 subjects were enrolled in this study. Of the enrolled subjects 6 subjects did not meet the eligibility criteria and 548 subjects were dispensed a study lens. Of the dispensed subjects 535 subjects completed the study and 13 subjects were discontinued.

Participant milestones

Participant milestones
Measure	Senofilcon C Subjects that were randomized to receive the senofilcon C lens throughout the duration of the study.	Comfilcon A Subjects that were randomized to receive the comfilcon A lens throughout the duration of the study.	Lotrafilcon B Subjects that were randomized to receive the lotrafilcon B lens throughout the duration of the study.	Samfilcon A Subjects that were randomized to receive the samfilcon A lens throughout the duration of the study.
Overall Study STARTED	139	136	137	136
Overall Study COMPLETED	135	130	134	136
Overall Study NOT COMPLETED	4	6	3	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Senofilcon C Subjects that were randomized to receive the senofilcon C lens throughout the duration of the study.	Comfilcon A Subjects that were randomized to receive the comfilcon A lens throughout the duration of the study.	Lotrafilcon B Subjects that were randomized to receive the lotrafilcon B lens throughout the duration of the study.
Overall Study Adverse Event	0	1	0
Overall Study Lens Discomfort	1	0	1
Overall Study Lost to Follow-up	1	1	1
Overall Study Protocol Violation	0	1	0
Overall Study Withdrawal by Subject	1	1	0
Overall Study Dispensed incorrect study lens	0	1	1
Overall Study Did not wear lens at final visit	0	1	0
Overall Study Subject lost study lens	1	0	0

Baseline Characteristics

Clinical Study of Approved and Investigational Contact Lenses

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Senofilcon C n=139 Participants All subjects that wore the senofilcon C lens throughout the duration of the study.	Comfilcon A n=136 Participants All subjects that wore the comfilcon A lens throughout the duration of the study.	Lotrafilcon B n=137 Participants All subjects that wore the lotrafilcon B lens throughout the duration of the study.	Samfilcon A n=136 Participants All subjects that wore the samfilcon A lens throughout the duration of the study.	Total n=548 Participants Total of all reporting groups
Age, Continuous	29.1 years STANDARD_DEVIATION 6.24 • n=5 Participants	27.7 years STANDARD_DEVIATION 5.86 • n=7 Participants	28.6 years STANDARD_DEVIATION 5.63 • n=5 Participants	28.8 years STANDARD_DEVIATION 6.56 • n=4 Participants	28.6 years STANDARD_DEVIATION 6.11 • n=21 Participants
Sex: Female, Male Female	88 Participants n=5 Participants	98 Participants n=7 Participants	86 Participants n=5 Participants	92 Participants n=4 Participants	364 Participants n=21 Participants
Sex: Female, Male Male	51 Participants n=5 Participants	38 Participants n=7 Participants	51 Participants n=5 Participants	44 Participants n=4 Participants	184 Participants n=21 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	1 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	1 participants n=21 Participants
Race/Ethnicity, Customized Asian	2 participants n=5 Participants	2 participants n=7 Participants	6 participants n=5 Participants	10 participants n=4 Participants	20 participants n=21 Participants
Race/Ethnicity, Customized Black or African American	13 participants n=5 Participants	10 participants n=7 Participants	9 participants n=5 Participants	12 participants n=4 Participants	44 participants n=21 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	1 participants n=5 Participants	1 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	2 participants n=21 Participants
Race/Ethnicity, Customized White	119 participants n=5 Participants	122 participants n=7 Participants	122 participants n=5 Participants	113 participants n=4 Participants	476 participants n=21 Participants
Race/Ethnicity, Customized Other	3 participants n=5 Participants	1 participants n=7 Participants	0 participants n=5 Participants	1 participants n=4 Participants	5 participants n=21 Participants
Region of Enrollment United States	139 participants n=5 Participants	136 participants n=7 Participants	137 participants n=5 Participants	136 participants n=4 Participants	548 participants n=21 Participants

PRIMARY outcome

Timeframe: Up to 1 month Follow-up

Population: All subjects that completed all study visits without a major protocol deviation.

Subjective Overall Comfort was evaluated using the Contact Lens User Experience Comfort scores (CLUE). CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.Range is 0 to 120. CLUE was collect at Baseline, Post Lens Fit 1-, 2-, 3- and 4- week follow-ups.