Trial Outcomes & Findings for Dual Focus Soft Contact Lens Wear Cessation Study (NCT NCT05779072)

Last Updated: 2023-11-01

Results Overview

Change in spherical equivalent refractive error (SERE) relative to baseline (i.e., at end of dual focus soft contact lens wear treatment of either 3 or 6 years). Cycloplegic autorefraction was used to measure refractive error.

Recruitment status

COMPLETED

Study phase

Target enrollment

83 participants

Primary outcome timeframe

1 year

Results posted on

2023-11-01

Participant Flow

Eighty-three participants were enrolled, and 76 participants completed the study. The primary reason was due to decreased vision related to astigmatism.

Unit of analysis: Eyes

Participant milestones

Participant milestones
Measure	Dual Focus for 3 Years Group of subjects who completed dual focus soft contact lens wear treatment for 3 years. Subjects refit to Single Vision Soft Contact Lens for 1 year.	Dual Focus for 6 Years Group of subjects who completed dual focus soft contact lens wear treatment for 6 years. Subjects refit to Single Vision Soft Contact Lens for 1 year.
Overall Study STARTED	40 80	43 86
Overall Study COMPLETED	39 78	37 74
Overall Study NOT COMPLETED	1 2	6 12

Reasons for withdrawal

Reasons for withdrawal
Measure	Dual Focus for 3 Years Group of subjects who completed dual focus soft contact lens wear treatment for 3 years. Subjects refit to Single Vision Soft Contact Lens for 1 year.	Dual Focus for 6 Years Group of subjects who completed dual focus soft contact lens wear treatment for 6 years. Subjects refit to Single Vision Soft Contact Lens for 1 year.
Overall Study Lost to Follow-up	0	1
Overall Study Withdrawal by Subject	1	5

Baseline Characteristics

Dual Focus Soft Contact Lens Wear Cessation Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dual Focus for 3 Years n=40 Participants Group of subjects who completed dual focus soft contact lens wear treatment for 3 years	Dual Focus for 6 Years n=43 Participants Group of subjects who completed dual focus soft contact lens wear treatment for 6 years	Total n=83 Participants Total of all reporting groups
Age, Continuous	16.1 years STANDARD_DEVIATION 1.58 • n=93 Participants	16.3 years STANDARD_DEVIATION 1.2 • n=4 Participants	16.2 years STANDARD_DEVIATION 1.39 • n=27 Participants
Sex: Female, Male Female	20 Participants n=93 Participants	22 Participants n=4 Participants	42 Participants n=27 Participants
Sex: Female, Male Male	20 Participants n=93 Participants	21 Participants n=4 Participants	41 Participants n=27 Participants
Race/Ethnicity, Customized Caucasian (European)	27 Participants n=93 Participants	28 Participants n=4 Participants	55 Participants n=27 Participants
Race/Ethnicity, Customized East Asian	10 Participants n=93 Participants	13 Participants n=4 Participants	23 Participants n=27 Participants
Race/Ethnicity, Customized Indian/Pakistani/SriLankan	5 Participants n=93 Participants	3 Participants n=4 Participants	8 Participants n=27 Participants
Race/Ethnicity, Customized Middle Eastern	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race/Ethnicity, Customized Hispanic - Latino	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Race/Ethnicity, Customized Mediterranean	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race/Ethnicity, Customized Black British	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants

PRIMARY outcome

Timeframe: 1 year

Population: \[Not specified\]

Outcome measures

Outcome measures
Measure	Dual Focus for 3 Years n=80 Eyes Group of subjects who completed dual focus soft contact lens wear treatment for 3 years	Dual Focus for 6 Years n=76 Eyes Group of subjects who completed dual focus soft contact lens wear treatment for 6 years
Change in Spherical Equivalent Refractive Error (SERE)	-0.23 D Standard Deviation 0.363	-0.21 D Standard Deviation 0.397

PRIMARY outcome

Timeframe: 1 year

Population: \[Not Specified\]

Change in axial length (AL) relative to baseline (i.e., at end of dual focus soft contact lens wear treatment of either 3 or 6 years). Partial coherence interferometry was used to measure axial length.

Outcome measures

Outcome measures
Measure	Dual Focus for 3 Years n=80 Eyes Group of subjects who completed dual focus soft contact lens wear treatment for 3 years	Dual Focus for 6 Years n=76 Eyes Group of subjects who completed dual focus soft contact lens wear treatment for 6 years
Change in Axial Length (AL)	0.09 mm Standard Deviation 0.090	0.10 mm Standard Deviation 0.103

Adverse Events

Dual Focus for 3 Years

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Dual Focus for 6 Years

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Dual Focus for 3 Years n=40 participants at risk Group of subjects who completed dual focus soft contact lens wear treatment for 3 years	Dual Focus for 6 Years n=43 participants at risk Group of subjects who completed dual focus soft contact lens wear treatment for 6 years
Infections and infestations Conjuctivitis	2.5% 1/40 • The data was collected in time frame of 1 year of study.	2.3% 1/43 • The data was collected in time frame of 1 year of study.
Product Issues Corneal Staining	2.5% 1/40 • The data was collected in time frame of 1 year of study.	2.3% 1/43 • The data was collected in time frame of 1 year of study.
Product Issues Discomfort	0.00% 0/40 • The data was collected in time frame of 1 year of study.	2.3% 1/43 • The data was collected in time frame of 1 year of study.

Additional Information

Paul Chamberlain

Coopervision

Phone: 9257306754

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place