Trial Outcomes & Findings for Senofilcon A Investigational Manufacturing Process (NCT NCT01951703)

NCT ID: NCT01951703

Last Updated: 2018-06-19

Results Overview

Contact Lens User Experience Comfort scores (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.

Recruitment status

COMPLETED

Study phase

Target enrollment

136 participants

Primary outcome timeframe

2 weeks

Results posted on

2018-06-19

Participant Flow

A total of 136 subjects were enrolled in the study; 9 subjects did not meet the inclusion and exclusion criteria and not randomized. Of the 127 randomized subjects, 6 were prematurely discontinued from the study and 2 were excluded from the analysis due to major protocol deviations.

Participant milestones

Participant milestones
Measure	Control/Test Subjects that received Control lens, senofilcon A for the first two weeks and then received Test lens senofilcon A in the last two weeks of the study.	Test/Control Subjects that received Test lens, senofilcon A for the first two weeks and then received Control lens senofilcon A in the last two weeks of the study.
First Intervention STARTED	64	63
First Intervention COMPLETED	61	62
First Intervention NOT COMPLETED	3	1
Second Intervention STARTED	61	62
Second Intervention COMPLETED	61	60
Second Intervention NOT COMPLETED	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Control/Test Subjects that received Control lens, senofilcon A for the first two weeks and then received Test lens senofilcon A in the last two weeks of the study.	Test/Control Subjects that received Test lens, senofilcon A for the first two weeks and then received Control lens senofilcon A in the last two weeks of the study.
First Intervention Withdrawal by Subject	1	0
First Intervention Subject was not compliant	1	1
First Intervention Physician Decision	1	0
Second Intervention Protocol Violation	0	1
Second Intervention Unsatisfactory Lens fitting	0	1

Baseline Characteristics

Senofilcon A Investigational Manufacturing Process

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control/Test n=64 Participants Subjects who received Control lens, senofilcon A for the first two weeks of the study and then received Test lens, senofilcon A in the last two weeks of the study.	Test/Control n=63 Participants Subjects who received Test lens, senofilcon A for the first two weeks of the study and then received Control lens, senofilcon A in the last two weeks of the study.	Total n=127 Participants Total of all reporting groups
Age, Categorical <=18 years	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	62 Participants n=5 Participants	63 Participants n=7 Participants	125 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	35.5 years STANDARD_DEVIATION 9.73 • n=5 Participants	35.0 years STANDARD_DEVIATION 9.63 • n=7 Participants	35.2 years STANDARD_DEVIATION 9.60 • n=5 Participants
Sex: Female, Male Female	52 Participants n=5 Participants	50 Participants n=7 Participants	102 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	13 Participants n=7 Participants	25 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) White	61 Participants n=5 Participants	56 Participants n=7 Participants	117 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	64 participants n=5 Participants	63 participants n=7 Participants	127 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 weeks

Population: Includes all subjects who completed all visits and did not have any major protocol deviation impacting the primary outcomes

Outcome measures

Outcome measures
Measure	Control, Senofilcon A n=119 Participants Subjects who received Control lens, senofilcon A in either the first two weeks or the last two weeks of the study.	Test, Senofilcon A n=119 Participants Subject who received Test lens, senofilcon A in either the first two weeks or the last two weeks of the study.
Subjective Overall Comfort (Using CLUE )	63.3 units on a scale Standard Deviation 24.85	65.0 units on a scale Standard Deviation 26.75

PRIMARY outcome

Timeframe: 2 weeks

Population: Includes all subjects who completed all visits and did not have any major protocol deviation impacting the primary outcomes

Contact Lens User Experience Vision scores (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.

Outcome measures

Outcome measures
Measure	Control, Senofilcon A n=119 Participants Subjects who received Control lens, senofilcon A in either the first two weeks or the last two weeks of the study.	Test, Senofilcon A n=119 Participants Subject who received Test lens, senofilcon A in either the first two weeks or the last two weeks of the study.
Subjective Overall Vision (Using CLUE )	65.2 units on a scale Standard Deviation 20.75	65.2 units on a scale Standard Deviation 20.12

Adverse Events

Control, Senofilcon A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Test, Senofilcon 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

Jurandir Araujo

Clinical Compliance Manager

Phone: 904 443-1379

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60