Trial Outcomes & Findings for Comparison of Two Silicone Hydrogel Multifocal Contact Lenses (NCT NCT04093258)

Last Updated: 2021-12-01

Results Overview

Lens centration was assessed using a biomicroscope and was graded using the scale (Grade: 0, 1,2) with grade 0 represent Centered, Grade 1 = Slightly Decentered and Grade 2= substantially decentered. The data was then dichotomized into two groups: those with grade 1 or higher and those with grade 0 (centered). The percentage of participants with Grade 0 Lens centration was reported.

Recruitment status

COMPLETED

Study phase

Target enrollment

42 participants

Primary outcome timeframe

6 to 8 days

Results posted on

2021-12-01

Participant Flow

In total, 42 subjects were enrolled in this study; of which, 41 were randomly assigned into 2 sequences while, 1 subject failed to meet all eligibility criteria. Of the total assigned subjects, 40 subjects completed the study while, 1 subject was discontinued from the study.

Participant milestones

Participant milestones
Measure	Test/Control Subjects randomized to this sequence received the Test lens during the first period and then received the Control lens during the second period.	Control/Test Subjects randomized to this sequence received the Control lens during the first period and then received the Test lens during the second period.
Period 1 STARTED	21	20
Period 1 COMPLETED	21	20
Period 1 NOT COMPLETED	0	0
Period 2 STARTED	21	20
Period 2 COMPLETED	20	20
Period 2 NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Test/Control Subjects randomized to this sequence received the Test lens during the first period and then received the Control lens during the second period.	Control/Test Subjects randomized to this sequence received the Control lens during the first period and then received the Test lens during the second period.
Period 2 Subject no longer meets the eligibility criteria	1	0

Baseline Characteristics

Comparison of Two Silicone Hydrogel Multifocal Contact Lenses

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Subjects n=41 Participants All subjects dispensed a study lens.
Age, Continuous	51.2 Years STANDARD_DEVIATION 6.76 • n=5 Participants
Sex: Female, Male Female	32 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	39 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment USA	41 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 to 8 days

Population: All subjects dispensed at least one study lens.

Outcome measures

Outcome measures
Measure	Test n=41 Participants Subjects that wore the Test lens in either the first or second period of the study.	Control n=41 Participants Subjects that wore the Control lens in either the first or second period of the study.
Percentage of Participants With Lens Centration	97.3 Percentage of participants	91.9 Percentage of participants

PRIMARY outcome

Timeframe: 6 to 8 days

Population: All subjects dispensed at least one study lens.

Lens movement in primary gaze was assessed using a biomicroscope and was graded using the scale (Insufficient/Unacceptable (-2), Minimal/Acceptable (-1), Optimal (0), Moderate/Acceptable (+1) and Excessive/Unacceptable (+2)) with Optimal (0) representing no lens movement. The data was then dichotomized into two groups: those with Optimal Lens movement and otherwise (-2, -1, +1 and +2). The percentage of participants with Optimal Lens movement was reported.

Outcome measures

Outcome measures
Measure	Test n=41 Participants Subjects that wore the Test lens in either the first or second period of the study.	Control n=41 Participants Subjects that wore the Control lens in either the first or second period of the study.
Percentage of Participants With Lens Movement	97.3 Percentage of participants	91.9 Percentage of participants

SECONDARY outcome

Timeframe: 6 to 8 days

Population: All subjects who had successfully completed all visits and did not substantially deviate from the protocol as determined by the trial cohort review committee prior to database hard lock. Here 'N' (number of participants analyzed) included all participants who were evaluable for this outcome measure.

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, aged 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.

Outcome measures

Outcome measures
Measure	Test n=37 Participants Subjects that wore the Test lens in either the first or second period of the study.	Control n=37 Participants Subjects that wore the Control lens in either the first or second period of the study.
Overall Handling Scores	60.3 CLUE points Standard Deviation 19.02	55.3 CLUE points Standard Deviation 18.71

Adverse Events

Test

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

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

Thomas R. Karkkainen, OD, MS, FAAO

Johnson & Johnson Vision Care

Phone: 1-800-843-2020

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60