Trial Outcomes & Findings for Clinical Evaluation of a Multifocal Contact Lens on Symptomatic Patients (NCT NCT01016652)

Results Overview

The Contact Lens User Experience (CLUE) Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response, with scores ranging from 0-120.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

49 participants

Primary outcome timeframe

week 4

Results posted on

2018-06-19

Participant Flow

This was a four week, 49 subject, doubly-masked, daily wear, two-part crossover study. Recruited patients were emerging presbyopic (35-47 years) and soft CL wearing who were experiencing any near vision symptoms.

A screening questionnaire (Near Vision Questionnaire, (NVQ)) was used to recruit subjects and to provide information about the wider population.

Participant milestones

Participant milestones
Measure	Etafilcon A Multifocal/ Etafilcon A Sphere etafilcon A multifocal/ etafilcon A sphere Arm: The first test lens for this arm, etafilcon A multifocal, was dispensed on Day 0 and to be worn a minimum of 2 hours before the assessment scheduled 12-17 days after the lens was fitted. Repeat for the second lens (sphere).	Etafilcon A Sphere/ Etafilcon A Multifocal etafilcon A sphere/ etafilcon A multifocal Arm: The first test lens for this arm, etafilcon A sphere, was dispensed on Day 0 and to be worn a minimum of 2 hours before the assessment scheduled 12-17 days after the lens was fitted. Repeat for the second lens (multifocal).
Period 1 STARTED	25	24
Period 1 COMPLETED	25	24
Period 1 NOT COMPLETED	0	0
Period 2 STARTED	25	24
Period 2 COMPLETED	25	24
Period 2 NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Evaluation of a Multifocal Contact Lens on Symptomatic Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Etafilcon A Multifocal/ Etafilcon A Sphere n=25 Participants etafilcon A multifocal/ etafilcon A sphere Arm: The first test lens for this arm, etafilcon A multifocal, was dispensed on Day 0 and to be worn a minimum of 2 hours before the assessment scheduled 12-17 days after the lens was fitted. Repeat for the second lens (sphere).	Etafilcon A Sphere\ Etafilcon A Multifocal n=24 Participants etafilcon A sphere/ etafilcon A multifocal Arm: The first test lens for this arm, etafilcon A sphere, was dispensed on Day 0 and to be worn a minimum of 2 hours before the assessment scheduled 12-17 days after the lens was fitted. Repeat for the second lens (multifocal).	Total n=49 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	25 Participants n=5 Participants	24 Participants n=7 Participants	49 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	42.3 years STANDARD_DEVIATION 3.4 • n=5 Participants	42.3 years STANDARD_DEVIATION 3.4 • n=7 Participants	42.3 years STANDARD_DEVIATION 3.4 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	18 Participants n=7 Participants	36 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants

PRIMARY outcome

Timeframe: week 4

Population: Analysis was on those subjects enrolled, randomized into one of two randomized arms, and who completed the study.

The Contact Lens User Experience (CLUE) Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response, with scores ranging from 0-120.

Outcome measures

Outcome measures
Measure	Etafilcon A Multifocal n=49 Participants etafilcon A multifocal worn.	Etafilcon A Sphere n=49 Participants etafilcon A sphere worn
Subject Reported Overall Vision Quality Using (CLUE)TM Questionnaire	41.0 units on a scale Interval 30.0 to 51.0	39.0 units on a scale Interval 28.0 to 50.0

PRIMARY outcome

Timeframe: week 4

Population: Analysis was on those who were randomized to either treatment arm with intent to treat. One eye was chosen.

The amplitude of accommodation is a measure of the eyes ability to accommodate or focus on near objects. The method used was the push-up/push-down method performed monocularly. One eye was occluded and using the smallest print the subject was able to read, the reading chart was slowly moved towards the subject. The subject was asked them to indicate when the print first becomes blurred. The distance was noted and the amplitude of accommodation was calculated.

Outcome measures

Outcome measures
Measure	Etafilcon A Multifocal n=49 Participants etafilcon A multifocal worn.	Etafilcon A Sphere n=49 Participants etafilcon A sphere worn
Monocular Amplitude of Accommodation	0.00 diopters Interval -0.075 to 0.025	0.00 diopters Interval -0.075 to 0.01

SECONDARY outcome

Timeframe: week 4

Population: The NV Questionnaire was administered to those enrolled in the study and randomized to either treatment arm.

Proportion of subjects reporting frequent/constant near vision problem per the Near Vision Questionnaire (NVQ). The NVQ was used to assess subjects' near vision problems. Subjects graded each question using a 5-level Likert-type scale (5-levels: never, infrequent, sometimes, frequently, constantly).

Outcome measures

Outcome measures
Measure	Etafilcon A Multifocal n=49 Participants etafilcon A multifocal worn.	Etafilcon A Sphere n=49 Participants etafilcon A sphere worn
Proportion of Subjects With Near Vision Symptoms as Assessed by the NVQ	53 percentage of participants	43 percentage of participants

SECONDARY outcome

Timeframe: week 4

Population: Analysis was on those subjects enrolled and randomized to either one of the arms with intent to treat.

Subject reported lens comfort was assessed using the CLUE Questionnaire. CLUE is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. Scores range from 0 -120.

Outcome measures

Outcome measures
Measure	Etafilcon A Multifocal n=49 Participants etafilcon A multifocal worn.	Etafilcon A Sphere n=49 Participants etafilcon A sphere worn
Subject Reported Lens Comfort Using CLUE Questionnaire	59.0 units on a scale Interval 38.0 to 75.0	59.0 units on a scale Interval 50.0 to 77.0

SECONDARY outcome

Timeframe: week 4

Population: Analysis was on those subjects randomized to either arm with the intent to treat.

Comfortable wearing time was measured using self-reported subject awareness of irritation at a given time of day, rounded to the nearest half-hour. Could be described as aware of issue or completely comfortable.

Outcome measures

Outcome measures
Measure	Etafilcon A Multifocal n=49 Participants etafilcon A multifocal worn.	Etafilcon A Sphere n=49 Participants etafilcon A sphere worn
Comfortable Wearing Time	14 hours Interval 11.0 to 15.0	14 hours Interval 12.0 to 14.5

SECONDARY outcome

Timeframe: Baseline

Population: Analysis was on those subjects who were randomized to either treatment arm with the intent to treat.

Utility of the use of the Binocular +/-1.00D accommodative flipper as a screening tool for those emerging presbyopia subjects

Outcome measures

Outcome measures
Measure	Etafilcon A Multifocal n=49 Participants etafilcon A multifocal worn.	Etafilcon A Sphere n=49 Participants etafilcon A sphere worn
Proportion of Subjects Benefiting From the Binocular +/-1.00D Accommodative Flipper	52 percentage of participants	58 percentage of participants

Adverse Events

Etafilcon A Multifocal

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Etafilcon A Sphere

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 Senior Principal Research Optometrist

Johnson & Johnson Vision Care

Phone: (904)443-3402

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Written authorization by the Sponsor is required for publication.
Publication restrictions are in place

Restriction type: OTHER