Trial Outcomes & Findings for Evaluation of Astigmatic Contact Lenses (NCT NCT03086447)

NCT ID: NCT03086447

Last Updated: 2018-07-10

Results Overview

Monocular distance visual acuity was measured with the study lens using a Snellen distance VA chart at an optical distance of 20 feet throughout the study. Observed VA data collected during all planned visits were dichotomized whether VA was "20/40 or better (acceptable VA)" or "worse than 20/40 (unacceptable VA)". VA of 20/40 with a negative modifier was considered worse than 20/40. The number of eye with acceptable VA was reported for each study lens.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 267 participants
• Primary outcome timeframe: Up to 4-Week Follow-up
• Results posted on: 2018-07-10

Participant Flow

A total of 267 subjects were enrolled into this study. Of the enrolled 262 were randomized to receive a study lens, while 5 subjects failed to meet the eligibility criteria. Of the 262 randomized subjects, 231 completed the study and 31 subjects were discontinued.

One subject was randomized to the Test lens but in actuality was dispensed the control lens, therefore his/her data was summarized with the control data, while this/her demographic information is apart of the Test summary.

Participant milestones

Measure	Lotrafilcon B (Control) Subjects that wore the lotrafilcon B lens throughout the entire duration of the study.	Senofilcon C Toric (Test) Subjects that wore the senofilcon C toric lens throughout the entire duration of the study.
Overall Study STARTED	132	130
Overall Study COMPLETED	121	110
Overall Study NOT COMPLETED	11	20

Reasons for withdrawal

Measure	Lotrafilcon B (Control) Subjects that wore the lotrafilcon B lens throughout the entire duration of the study.	Senofilcon C Toric (Test) Subjects that wore the senofilcon C toric lens throughout the entire duration of the study.
Overall Study No Longer Meets Eligibility Criteria	0	1
Overall Study Lost Lens	2	5
Overall Study Product quality complaint	0	1
Overall Study Lens Damage	1	6
Overall Study Unsatisfactory Lens Fitting	0	1
Overall Study Test Article No Longer Available	1	0
Overall Study Protocol Violation	2	4
Overall Study Lost to Follow-up	0	1
Overall Study Adverse Event	3	0
Overall Study Lens Discomfort	2	1

Baseline Characteristics

Evaluation of Astigmatic Contact Lenses

Baseline characteristics by cohort

Measure	Lotrafilcon B (Control) n=132 Participants Subjects that wore the lotrafilcon B lens throughout the entire duration of the study.	Senofilcon C Toric (Test) n=130 Participants Subjects that wore the senofilcon C toric lens throughout the entire duration of the study.	Total n=262 Participants Total of all reporting groups
Age, Continuous	29.3 Years STANDARD_DEVIATION 6.50 • n=5 Participants	29.4 Years STANDARD_DEVIATION 5.81 • n=7 Participants	29.4 Years STANDARD_DEVIATION 6.16 • n=5 Participants
Sex: Female, Male Female	95 Participants n=5 Participants	74 Participants n=7 Participants	169 Participants n=5 Participants
Sex: Female, Male Male	37 Participants n=5 Participants	56 Participants n=7 Participants	93 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Asian	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	13 Participants n=5 Participants	12 Participants n=7 Participants	25 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized White	110 Participants n=5 Participants	111 Participants n=7 Participants	221 Participants n=5 Participants
Race/Ethnicity, Customized Other	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	132 Participants n=5 Participants	130 Participants n=7 Participants	262 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 4-Week Follow-up

Population: All subjects who administered the test article and have at least one observation after lens insertion.

Monocular distance visual acuity was measured with the study lens using a Snellen distance VA chart at an optical distance of 20 feet throughout the study. Observed VA data collected during all planned visits were dichotomized whether VA was "20/40 or better (acceptable VA)" or "worse than 20/40 (unacceptable VA)". VA of 20/40 with a negative modifier was considered worse than 20/40. The number of eye with acceptable VA was reported for each study lens.

Outcome measures

Measure	Senofilcon C Toric (Test) n=258 Number of Eyes Subjects that wore the senofilcon C toric lens throughout the entire duration of the study.	Lotrafilcon B (Control) n=264 Number of Eyes Subjects that wore the lotrafilcon B lens throughout the entire duration of the study.
Monocular Distance Visual Acuity (VA)	258 Eyes	263 Eyes

PRIMARY outcome

Timeframe: 15 Minutes Post Lens Fitting

Population: All subjects who administered the test article and have at least one observation after lens insertion.

Lens fit characteristics were assessed using slit lamp with respect to lens position, movement and tightness. Each lens fit collected at fitting (visit 1) was judged being either acceptable or unacceptable based on the static and dynamic fit characteristic. The number of eyes with acceptable lens fit was reported for each study lens.

Outcome measures

Measure	Senofilcon C Toric (Test) n=258 Number of Eyes Subjects that wore the senofilcon C toric lens throughout the entire duration of the study.	Lotrafilcon B (Control) n=264 Number of Eyes Subjects that wore the lotrafilcon B lens throughout the entire duration of the study.
Lens Fit Acceptance	258 Eyes	264 Eyes

PRIMARY outcome

Timeframe: 15 Minutes Post Lens Fitting

Population: All subjects who administered the test article and have at least one observation after lens insertion.

Lens rotational stability with blink was assessed using slit lamp with beam that can be rotated. The stability of the scribe mark rotational position during a series of normal (unforced) blinks was assessed, and then dichotomized whether stability was less than or equal to 5-degree (acceptable stability) or greater (unacceptable stability). The number of eye with acceptable stability was reported for each lens.

Outcome measures

Measure	Senofilcon C Toric (Test) n=258 Number of Eyes Subjects that wore the senofilcon C toric lens throughout the entire duration of the study.	Lotrafilcon B (Control) n=264 Number of Eyes Subjects that wore the lotrafilcon B lens throughout the entire duration of the study.
Lens Stability With Blink	258 Eyes	264 Eyes

PRIMARY outcome

Timeframe: 15-minutes Post Lens Insertion

Population: All subjects who administered the test article and have at least one observation after lens insertion.

Lens rotation was assessed using slit lamp with beam that can be rotated. The rotational error (assume shortest distance) and direction (base toward the nose or temple) were calculated, and then absolute rotation was dichotomized whether absolute rotation was less than or equal to 10-degree (acceptable rotation) or greater (unacceptable rotation). The number of eyes with acceptable lens rotation for each lens was reported.

Outcome measures

Measure	Senofilcon C Toric (Test) n=258 Number of Eyes Subjects that wore the senofilcon C toric lens throughout the entire duration of the study.	Lotrafilcon B (Control) n=266 Number of Eyes Subjects that wore the lotrafilcon B lens throughout the entire duration of the study.
Absolute Lens Rotation	255 Eyes	261 Eyes

PRIMARY outcome

Timeframe: Up to 4-Week Follow-up

Population: All subjects who administered the test article and have at least one observation after lens insertion.

Contact lens related corneal staining was assessed using slit lamp throughout the study. Corneal staining was graded using a 5-level scale: 0=no staining, 1=trace, 2=mild, 3=moderate and 4=severe. Corneal staining data collected during planned and unplanned visits were dichotomized whether the level of corneal stating was grade 3 or higher (unacceptable CS) or less than grade 3 (acceptable CS). The number of eyes with Grade 3 or higher was reported for each lens type.

Outcome measures

Measure	Senofilcon C Toric (Test) n=258 Number of Eyes Subjects that wore the senofilcon C toric lens throughout the entire duration of the study.	Lotrafilcon B (Control) n=266 Number of Eyes Subjects that wore the lotrafilcon B lens throughout the entire duration of the study.
Corneal Staining	0 Eyes	3 Eyes

SECONDARY outcome

Timeframe: Up to 4- Week Follow-up

Population: All subjects who have successfully completed all required visits without any major protocol deviations.

Overall comfort 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.

Outcome measures

Measure	Senofilcon C Toric (Test) n=108 Participants Subjects that wore the senofilcon C toric lens throughout the entire duration of the study.	Lotrafilcon B (Control) n=120 Participants Subjects that wore the lotrafilcon B lens throughout the entire duration of the study.
Overall Comfort	61.4 Units on a Scale Standard Deviation 23.45	52.0 Units on a Scale Standard Deviation 24.45

SECONDARY outcome

Timeframe: Up to 4- Week Follow-up

Population: All subjects who have successfully completed all required visits without any major protocol deviations.

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.

Outcome measures

Measure	Senofilcon C Toric (Test) n=108 Participants Subjects that wore the senofilcon C toric lens throughout the entire duration of the study.	Lotrafilcon B (Control) n=120 Participants Subjects that wore the lotrafilcon B lens throughout the entire duration of the study.
Overall Handling	63.5 Units on a Scale Standard Deviation 20.90	65.7 Units on a Scale Standard Deviation 19.77

SECONDARY outcome

Timeframe: 15 Minutes Post Lens Fitting

Population: All subjects who have successfully completed all required visits without any major protocol deviations.

Monocular distance visual acuity was measured with the study lens using a Snellen distance VA chart at an optical distance of 20 feet. Observed VA data collected at fitting were dichotomized whether VA was "20/20 or better (optimal VA)" or "worse than 20/20". VA of 20/20 with a negative modifier was considered worse than 20/20. The number of eyes with 20/20 vision was reported for each study lens.

Outcome measures

Measure	Senofilcon C Toric (Test) n=216 Number of Eyes Subjects that wore the senofilcon C toric lens throughout the entire duration of the study.	Lotrafilcon B (Control) n=240 Number of Eyes Subjects that wore the lotrafilcon B lens throughout the entire duration of the study.
Monocular Distance Visual Acuity (VA)	177 Eyes	184 Eyes

Adverse Events

Lotrafilcon B (Control)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Senofilcon C Toric (Test)

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

Kristy Canavan- SENIOR PRINCIPAL RESEARCH OPTOMETRIST

Johnson & Johnson Vision

Phone: 904 443-1474

Email: KCANAVA2@its.jnj.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60