Trial Outcomes & Findings for Clinical Evaluation of Multifocal Toric Contact Lenses (NCT NCT03208088)

NCT ID: NCT03208088

Last Updated: 2020-09-10

Results Overview

Overall handling was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. 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 with a range of 0-120.

Recruitment status

COMPLETED

Study phase

Target enrollment

96 participants

Primary outcome timeframe

15 minutes

Results posted on

2020-09-10

Participant Flow

A total of 96 subjects were enrolled in this study, of which 91 subjects were assigned at least 1 study lens, 5 subjects failed to meet all eligibility criteria. Of the total assigned subjects, 88 completed the study, while 3 were discontinued.

Subjects were randomized to 1 of 10 unique lens sequences.

Participant milestones

Participant milestones
Measure	Test 3/Test 2/Test 4/Test 1/Control Subjects randomized to this sequence received the following treatments in order: Test 3 in period 1, Test 2 in period 2, Test 4 in period 3, Test 1 in period 4, Control in period 5.	Test 3/Test 4/Test 2/Control/Test 1 Subjects randomized to this sequence received the following treatments in order: Test 3 in period 1, Test 4 in period 2, Test 2 in period 3, Control in period 4, Test 1 in period 5.	Test 1/Control/Test 2/Test 4/Test 3 Subjects randomized to this sequence received the following treatments in order: Test 1 in period 1, Control in period 2, Test 2 in period 3, Test 4 in period 4, Test 3 in period 5.	Test 1/Test 2/Control/Test 3/Test 4 Subjects randomized to this sequence received the following treatments in order: Test 1 in period 1, Test 2 in period 2, Control in period 3, Test 3 in period 4, Test 4 in period 5.	Control/Test 1/Test 4/Test 2/Test 3 Subjects randomized to this sequence received the following treatments in order: Control in period 1, Test 1 in period 2, Test 4 in period 3, Test 2 in period 4, Test 3 in period 5.	Control/Test 4/Test 1/Test 3/Test 2 Subjects randomized to this sequence received the following treatments in order: Control in period 1, Test 4 in period 2, Test 1 in period 3, Test 3 in period 4, Test 2 in period 5.	Test 2/Test 3/Test 1/Test 4 /Control Subjects randomized to this sequence received the following treatments in order: Test 2 in period 1, Test 3 in period 2, Test 1 in period 3, Test 4 in period 4, Control in period 5.	Test 2/Test 1/Test 3/Control/Test 4 Subjects randomized to this sequence received the following treatments in order: Test 2 in period 1, Test 1 in period 2, Test 3 in period 3, Control in period 4, Test 4 in period 5.	Test 4/Test 3/Control/Test 2/Test 1 Subjects randomized to this sequence received the following treatments in order: Test 4 in period 1, Test 3 in period 2, Control in period 3, Test 2 in period 4, Test 1 in period 5.	Test 4/Control/Test 3/Test 1/Test 2 Subjects randomized to this sequence received the following treatments in order: Test 4 in period 1, Control in period 2, Test 3 in period 3, Test 1 in period 4, Test 2 in period 5.
Period 1 STARTED	10	9	10	9	9	9	8	10	8	9
Period 1 COMPLETED	10	9	10	9	9	9	8	10	8	9
Period 1 NOT COMPLETED	0	0	0	0	0	0	0	0	0	0
Period 2 STARTED	10	9	10	9	9	9	8	10	8	9
Period 2 COMPLETED	10	9	10	9	9	9	8	10	7	9
Period 2 NOT COMPLETED	0	0	0	0	0	0	0	0	1	0
Period 3 STARTED	10	9	10	9	9	9	8	10	7	9
Period 3 COMPLETED	10	9	10	8	9	9	8	10	7	9
Period 3 NOT COMPLETED	0	0	0	1	0	0	0	0	0	0
Period 4 STARTED	10	9	10	8	9	9	8	10	7	9
Period 4 COMPLETED	10	9	10	7	9	9	8	10	7	9
Period 4 NOT COMPLETED	0	0	0	1	0	0	0	0	0	0
Period 5 STARTED	10	9	10	7	9	9	8	10	7	9
Period 5 COMPLETED	10	9	10	7	9	9	8	10	7	9
Period 5 NOT COMPLETED	0	0	0	0	0	0	0	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Test 1/Test 2/Control/Test 3/Test 4 Subjects randomized to this sequence received the following treatments in order: Test 1 in period 1, Test 2 in period 2, Control in period 3, Test 3 in period 4, Test 4 in period 5.	Test 4/Test 3/Control/Test 2/Test 1 Subjects randomized to this sequence received the following treatments in order: Test 4 in period 1, Test 3 in period 2, Control in period 3, Test 2 in period 4, Test 1 in period 5.
Period 2 Withdrawal by Subject	0	1
Period 3 Unsatisfactory Test Article	1	0
Period 4 Unsatisfactory Test Article	1	0

Baseline Characteristics

Clinical Evaluation of Multifocal Toric Contact Lenses

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Completed Subjects n=88 Participants All subjects who were administered study article and completed all required study visits.
Age, Continuous	51.1 Years STANDARD_DEVIATION 7.59 • n=5 Participants
Sex: Female, Male Female	62 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants
Race/Ethnicity, Customized Asian	7 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	7 Participants n=5 Participants
Race/Ethnicity, Customized White	73 Participants n=5 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants
Region of Enrollment United States	88 Participants n=5 Participants

PRIMARY outcome

Timeframe: 15 minutes

Population: All subjects who had successfully completed all visits and did not substantially deviate from the protocol.

Outcome measures

Outcome measures
Measure	Test 1 n=67 Participants Subjects that wore the Test 1 lens in either the first, second, third, fourth, or fifth period of the study.	Test 2 n=67 Participants Subjects that wore the Test 2 lens in either the first, second, third, fourth, or fifth period of the study.	Control n=67 Participants Subjects that wore the Control lens in either the first, second, third, fourth, or fifth period of the study.
Overall Handling Comparison Between Test 1/Test 2 and Control	57.1 units on a scale Standard Deviation 21.34	53.3 units on a scale Standard Deviation 22.47	52.3 units on a scale Standard Deviation 23.88

SECONDARY outcome

Timeframe: 15 minutes

Population: All subjects who had successfully completed all visits and did not substantially deviate from the protocol.