Trial Outcomes & Findings for Evaluation of Daily Disposable Silicone Hydrogel Multifocal Toric Contact Lenses (NCT NCT04974697)

NCT ID: NCT04974697

Last Updated: 2022-11-14

Results Overview

Overall vision 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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 95 participants
• Primary outcome timeframe: 2-Week Follow-up
• Results posted on: 2022-11-14

Participant Flow

A total of 95 subjects were enrolled into this study. Of those enrolled, 86 were dispensed study lenses, while 9 subjects failed to meet all eligibility criteria. Of those dispensed, 84 completed the study while 2 subjects were discontinued.

Participant milestones

Measure	Multifocal Toric Contact Lens in Senofilcon A (C3) With UV/HEV Blocker Subjects that wore the multifocal toric Contact Lens in senofilcon A (C3) with UV/HEV blocker during any point of the study.
Overall Study STARTED	86
Overall Study COMPLETED	84
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	Multifocal Toric Contact Lens in Senofilcon A (C3) With UV/HEV Blocker Subjects that wore the multifocal toric Contact Lens in senofilcon A (C3) with UV/HEV blocker during any point of the study.
Overall Study Unsatisfactory lens fitting due to test article	1
Overall Study Lens discomfort	1

Baseline Characteristics

Evaluation of Daily Disposable Silicone Hydrogel Multifocal Toric Contact Lenses

Baseline characteristics by cohort

Measure	Myope n=48 Participants subjects were classified as Myopic if the distance spherical component of their refractive error was in the range of -1.25 D to -3.75 D	Hyperope n=38 Participants subjects were classified as Hyperopic if the distance spherical component of their refractive error was in the range of +1.25 D to +3.75 D	Total n=86 Participants Total of all reporting groups
Age, Continuous	48.5 Years STANDARD_DEVIATION 6.28 • n=5 Participants	56.7 Years STANDARD_DEVIATION 7.36 • n=7 Participants	52.2 Years STANDARD_DEVIATION 7.88 • n=5 Participants
Sex: Female, Male Female	35 Participants n=5 Participants	27 Participants n=7 Participants	62 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	11 Participants n=7 Participants	24 Participants n=5 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized White	43 Participants n=5 Participants	32 Participants n=7 Participants	75 Participants n=5 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	48 Participants n=5 Participants	38 Participants n=7 Participants	86 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2-Week Follow-up

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

Overall vision 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	Multifocal Toric Contact Lens in Senofilcon A (C3) With UV/HEV Blocker n=83 Participants Subject that wore the multifocal toric contact lens in senofilcon A (C3) with UV/HEV blocker throughout the entire duration of the study. The average CLUE vision score for each sphere stratum (Hyperope and Myope) was reported.
Overall Vision Myope	58.37 Units on a Scale Standard Deviation 21.586
Overall Vision Hyperope	53.53 Units on a Scale Standard Deviation 21.160

PRIMARY outcome

Timeframe: 2-Week Follow-up

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

Binocular visual performance on logMAR (Logarithm of Minimal Angle of Resolution) scale was evaluated at distance (4 m),intermediate (64 cm) and near (40 cm) under high luminance high contrast lighting condition using ETDRS (Early Treatment Diabetic Retinopathy Study) charts. The room illuminance was required to be between 7.3 and 7.9 EV (394-597 lux). For Distance (4 m), the acceptable range for the chart luminance was 10.5-10.7 EV (181-208 cd/m2). For Intermediate (64cm) and Near (40cm), the acceptable range for the chart luminance 10.8-11.1 EV (223-274 cd/m2). Letter by-letter results calculated the visual performance score for each chart read. A logMAR score closer to zero, or below zero, indicates a better visual acuity. A logMAR visual performance score of 0.0 is equivalent to Snellen visual acuity of 20/20. Hyperopes and myopes were combined based on historical data for subjects in this study with regard to visual performance logMAR.

Outcome measures

Measure	Multifocal Toric Contact Lens in Senofilcon A (C3) With UV/HEV Blocker n=83 Participants Subject that wore the multifocal toric contact lens in senofilcon A (C3) with UV/HEV blocker throughout the entire duration of the study. The average CLUE vision score for each sphere stratum (Hyperope and Myope) was reported.
LogMAR Visual Acuity Distance (4M)	-0.12 LogMAR Standard Deviation 0.083
LogMAR Visual Acuity Intermediate (64 cm)	-0.05 LogMAR Standard Deviation 0.089
LogMAR Visual Acuity Near (40 cm)	0.06 LogMAR Standard Deviation 0.125

SECONDARY outcome

Timeframe: Up to 2-Week Follow-up

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

Overall vision 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. The change from baseline was calculated as the 2 week follow-up scores minus baseline scores. Change from baseline scores range from -120 to 120, where higher change from baseline scores indicate better performance. The average change from baseline was reported.

Outcome measures

Measure	Multifocal Toric Contact Lens in Senofilcon A (C3) With UV/HEV Blocker n=83 Participants Subject that wore the multifocal toric contact lens in senofilcon A (C3) with UV/HEV blocker throughout the entire duration of the study. The average CLUE vision score for each sphere stratum (Hyperope and Myope) was reported.
Change From Baseline CLUE Vision Score Myope	8.40 Units on a Scale Standard Deviation 18.163
Change From Baseline CLUE Vision Score Hyperope	5.03 Units on a Scale Standard Deviation 18.799

SECONDARY outcome

Timeframe: Up to 2-Week Follow-up

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

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. The change from baseline was calculated as the 2- week follow-up scores minus baseline scores. Change from baseline scores range from -120 to 120, where higher change from baseline scores indicate better performance. The average change from baseline was reported.

Outcome measures

Measure	Multifocal Toric Contact Lens in Senofilcon A (C3) With UV/HEV Blocker n=83 Participants Subject that wore the multifocal toric contact lens in senofilcon A (C3) with UV/HEV blocker throughout the entire duration of the study. The average CLUE vision score for each sphere stratum (Hyperope and Myope) was reported.
Change From Baseline CLUE Comfort Score Myope	6.85 Units on a Scale Standard Deviation 22.912
Change From Baseline CLUE Comfort Score Hyperope	3.30 Units on a Scale Standard Deviation 25.123

SECONDARY outcome

Timeframe: Up to 2-Week Follow-up

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

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. The change from baseline was calculated as the 2- week follow-up scores minus baseline scores. Change from baseline scores range from -120 to 120, where higher change from baseline scores indicate better performance. The average change from baseline was reported.

Outcome measures

Measure	Multifocal Toric Contact Lens in Senofilcon A (C3) With UV/HEV Blocker n=83 Participants Subject that wore the multifocal toric contact lens in senofilcon A (C3) with UV/HEV blocker throughout the entire duration of the study. The average CLUE vision score for each sphere stratum (Hyperope and Myope) was reported.
Change From Baseline CLUE Handling Score Myope	11.22 Units on a Scale Standard Deviation 22.261
Change From Baseline CLUE Handling Score Hyperope	10.02 Units on a Scale Standard Deviation 20.553

Adverse Events

Multifocal Toric Contact Lens in Senofilcon A (C3) With UV/HEV Blocker

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

Ross Franklin, BAppSc-Optom

Johnson & Johnson Vision Care (JJVC)

Phone: 1-800-843-2020

Email: RFRANKL1@its.jnj.com

Results disclosure agreements

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

Restriction type: GT60