Trial Outcomes & Findings for 2-week Evaluation of Marketed Silicone Hydrogel Contact Lenses in Indian Population (NCT NCT02394808)

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

54 participants

Primary outcome timeframe

11 days Post fit

Results posted on

2018-06-19

Participant Flow

A total of 54 subjects were enrolled in this study. Of the enrolled subjects all 54 were dispensed a study lens. Of the dispensed 52 completed the study while 2 were discontinued.

Participant milestones

Participant milestones
Measure	Senofilcon A/ Lotrafilcon B Subjects randomized to this sequence first wore the senofilcon A lens and then wore the lotrafilcon B lens.	Lotrafilcon B/Senofilcon A Subjects randomized to this sequence first wore the lotrafilcon B lens and then wore the senofilcon A lens.
Period 1 STARTED	25	29
Period 1 COMPLETED	25	28
Period 1 NOT COMPLETED	0	1
Period 2 STARTED	25	28
Period 2 COMPLETED	24	28
Period 2 NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Senofilcon A/ Lotrafilcon B Subjects randomized to this sequence first wore the senofilcon A lens and then wore the lotrafilcon B lens.	Lotrafilcon B/Senofilcon A Subjects randomized to this sequence first wore the lotrafilcon B lens and then wore the senofilcon A lens.
Period 1 Unsatisfactory lens fitting	0	1
Period 2 Lost to Follow-up	1	0

Baseline Characteristics

2-week Evaluation of Marketed Silicone Hydrogel Contact Lenses in Indian Population

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dispensed Subjects n=54 Participants All subjects that were dispensed at least one study lens throughout the duration of the study.
Age, Continuous	25.83 years STANDARD_DEVIATION 4.621 • n=5 Participants
Sex: Female, Male Female	38 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants
Race/Ethnicity, Customized Asian	54 participants n=5 Participants
Region of Enrollment India	54 participants n=5 Participants

PRIMARY outcome

Timeframe: 11 days Post fit

Population: 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.

Outcome measures

Outcome measures
Measure	Senofilcon A n=48 Participants Subjects that wore the senofilcon A lens in either the first or second period of the study.	Lotrafilcon B n=48 Participants Subjects that wore the lotrafilcon B lens in either the first or second period of the study.
Subjective Overall Comfort	58.65 units on a scale Standard Deviation 18.685	59.44 units on a scale Standard Deviation 16.458

PRIMARY outcome

Timeframe: 11 days post fit

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

Subjective Overall quality of Vision 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.

Outcome measures

Outcome measures
Measure	Senofilcon A n=48 Participants Subjects that wore the senofilcon A lens in either the first or second period of the study.	Lotrafilcon B n=48 Participants Subjects that wore the lotrafilcon B lens in either the first or second period of the study.
Subjective Overall Quality of Vision	55.60 units on a scale Standard Deviation 16.490	58.71 units on a scale Standard Deviation 14.035

Adverse Events

Senofilcon A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Lotrafilcon B

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

Tawnya Wilson O.D. SR. MANAGER GLOBAL CLINICAL SALES EDU

Johnson & Johnson Vision Care Inc.

Phone: 443-1834

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60