Trial Outcomes & Findings for Handling Comparison Between Two Contact Lens Types (NCT NCT02310126)

Last Updated: 2018-06-19

Results Overview

CLUE Overall Lens Handling is assessed using the Contact Lens User Experience (CLUE)TM questionnaire. CLUE is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population 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. 97% of the scores fall within 0 and 120 (mean +/-3XSD).

Recruitment status

COMPLETED

Study phase

Target enrollment

195 participants

Primary outcome timeframe

15 minutes post Contact Lens Insertion

Results posted on

2018-06-19

Participant Flow

This study enrolled a total of 195 subjects. Of those enrolled, 4 subjects did not meet the eligibility criteria, and 191 subjects were dispensed study lenses. Of those dispensed, subjects 189 completed the study and 2 subjects were discontinued. Subjects were stratified as either Hyperops or Myopes based on their sphere power.

Participant milestones

Participant milestones
Measure	Etafilcon A(Multi-focal)/Etafilcon A(Sphere) Subjects were randomized to one of two possible lens wear sequences. Subjects first received the etafilcon A (sphere) contact lens and then received the etafilcon A (multi-focal) contact lens.	Etafilcon A(Sphere)/Etafilcon A(Multi-focal) Subjects were randomized to one of two possible lens wear sequences. Subjects first received the etafilcon A (sphere) contact lens and then received the etafilcon A(multi-focal) contact lens.
Period 1 (15 Minutes) STARTED	94	97
Period 1 (15 Minutes) Hyperopes	38	33
Period 1 (15 Minutes) Myopes	56	64
Period 1 (15 Minutes) COMPLETED	94	95
Period 1 (15 Minutes) NOT COMPLETED	0	2
Period 2 (15 Minutes) STARTED	94	95
Period 2 (15 Minutes) Hyperopes	38	32
Period 2 (15 Minutes) Myopes	56	63
Period 2 (15 Minutes) COMPLETED	94	95
Period 2 (15 Minutes) NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Etafilcon A(Multi-focal)/Etafilcon A(Sphere) Subjects were randomized to one of two possible lens wear sequences. Subjects first received the etafilcon A (sphere) contact lens and then received the etafilcon A (multi-focal) contact lens.	Etafilcon A(Sphere)/Etafilcon A(Multi-focal) Subjects were randomized to one of two possible lens wear sequences. Subjects first received the etafilcon A (sphere) contact lens and then received the etafilcon A(multi-focal) contact lens.
Period 1 (15 Minutes) Lost to Follow-up	0	1
Period 1 (15 Minutes) Protocol Violation	0	1

Baseline Characteristics

Handling Comparison Between Two Contact Lens Types

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Etafilcon A(Multi-focal)/ Etafilcon A(Sphere) n=94 Participants Subjects were randomized to one of two possible lens wear sequences. Subjects first received the etafilcon A(multi-focal) contact lens and then received the etafilcon A(sphere) contact lens.	Etafilcon A(Sphere) / Etafilcon A(Multi-focal) n=97 Participants Subjects were randomized to one of two possible lens wear sequences. Subjects first received the etafilcon A(sphere) contact lens and then received the etafilcon A(multi-focal) contact lens.	Total n=191 Participants Total of all reporting groups
Age, Continuous Hyperopes, N=38, N=33, N=71	55.2 years STANDARD_DEVIATION 7.49 • n=5 Participants	57.3 years STANDARD_DEVIATION 6.45 • n=7 Participants	56.2 years STANDARD_DEVIATION 7.06 • n=5 Participants
Age, Continuous Myopes, N=56, N=64, N=120	50.8 years STANDARD_DEVIATION 7.03 • n=5 Participants	51.1 years STANDARD_DEVIATION 7.24 • n=7 Participants	51.0 years STANDARD_DEVIATION 7.12 • n=5 Participants
Sex: Female, Male Female	70 Participants n=5 Participants	83 Participants n=7 Participants	153 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants	14 Participants n=7 Participants	38 Participants n=5 Participants
Race/Ethnicity, Customized American Indian Or Alaska Native	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Race/Ethnicity, Customized Asian	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Race/Ethnicity, Customized Black of African American	4 participants n=5 Participants	8 participants n=7 Participants	12 participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Race/Ethnicity, Customized White	89 participants n=5 Participants	87 participants n=7 Participants	176 participants n=5 Participants
Region of Enrollment United States	94 participants n=5 Participants	97 participants n=7 Participants	191 participants n=5 Participants

PRIMARY outcome

Timeframe: 15 minutes post Contact Lens Insertion

Population: The analysis population consist of subjects that completed all study visits without a major protocol deviation. The analysis was conducted for each lens and strata.

Outcome measures

Outcome measures
Measure	Etafilcon A(Multi-focal) n=184 Participants Subjects that received the etafilcon A (multi-focal) contact lens during either the first or second period of the study.	Etafilcon A (Sphere) n=184 Participants Subjects that received the etafilcon A (sphere) contact lens during either the first or second period of the study.
Overall Lens Handling Using the Contact Lens User Experience(CLUE) TM Questionnaire. Hyperopes, N=69, N=69	53.44 units on a scale Standard Deviation 25.482	55.81 units on a scale Standard Deviation 26.432
Overall Lens Handling Using the Contact Lens User Experience(CLUE) TM Questionnaire. Myopes, N=115, N=115	61.70 units on a scale Standard Deviation 24.594	60.23 units on a scale Standard Deviation 23.369

Adverse Events

Etafilcon A (Multi-focal)

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, O.D., M.S., F.A.A.O., Sr. Principal Research Optometrist

Johnson & Johnson Vision Care Inc.

Phone: 904-443-3500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60