Trial Outcomes & Findings for Bifocal & Atropine in Myopia (BAM) Study (NCT NCT03312257)

Last Updated: 2022-12-09

Results Overview

Refractive error, as measured by cycloplegic autorefraction in both eyes, will be measured yearly to assess the difference in progression between the combination treatment (+2.50 D add soft bifocal lens and 0.01% atropine) group and the historical control group (+2.50 D add soft bifocal lens only) in the BLINK Study.

Recruitment status

COMPLETED

Study phase

Target enrollment

49 participants

Primary outcome timeframe

3 years

Results posted on

2022-12-09

Participant Flow

Participant milestones

Participant milestones
Measure	Multifocal D +2.50 Add & 0.01% Atropine The Biofinity Multifocal "D" with a +2.50 add is a soft bifocal contact lens that has a strong reading power; the 0.01% atropine is a low-dose atropine. Multifocal D +2.50 add \& 0.01% atropine: Biofinity Multifocal D +2.50 add is a monthly disposable contact lens commercially available from CooperVision; 0.01% atropine is low-dose atropine compounded by local pharmacy.
Overall Study STARTED	49
Overall Study COMPLETED	46
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Bifocal & Atropine in Myopia (BAM) Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Multifocal D +2.50 Add & 0.01% Atropine n=46 Participants The Biofinity Multifocal "D" with a +2.50 add is a soft bifocal contact lens that has a strong reading power; the 0.01% atropine is a low-dose atropine. Multifocal D +2.50 add \& 0.01% atropine: Biofinity Multifocal D +2.50 add is a monthly disposable contact lens commercially available from CooperVision; 0.01% atropine is low-dose atropine compounded by local pharmacy.
Age, Categorical <=18 years	46 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	10.1 years STANDARD_DEVIATION 1.2 • n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	45 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	10 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	28 Participants n=5 Participants
Race (NIH/OMB) More than one race	6 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	46 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 years

Outcome measures

Outcome measures
Measure	Multifocal D +2.50 Add & 0.01% Atropine n=46 Participants The Biofinity Multifocal "D" with a +2.50 add is a soft bifocal contact lens that has a strong reading power; the 0.01% atropine is a low-dose atropine. Multifocal D +2.50 add \& 0.01% atropine: Biofinity Multifocal D +2.50 add is a monthly disposable contact lens commercially available from CooperVision; 0.01% atropine is low-dose atropine compounded by local pharmacy.
Refractive Error Progression	-3.50 Diopter Standard Deviation 0.72

SECONDARY outcome

Timeframe: 3 years

Axial length progression, as measured by Lenstar in both eyes, will be measured yearly to assess the difference in progression between the combination treatment (+2.50 D add soft bifocal lens and 0.01% atropine) group and the historical control group (+2.50 D add soft bifocal lens only) in the BLINK Study.

Outcome measures

Outcome measures
Measure	Multifocal D +2.50 Add & 0.01% Atropine n=46 Participants The Biofinity Multifocal "D" with a +2.50 add is a soft bifocal contact lens that has a strong reading power; the 0.01% atropine is a low-dose atropine. Multifocal D +2.50 add \& 0.01% atropine: Biofinity Multifocal D +2.50 add is a monthly disposable contact lens commercially available from CooperVision; 0.01% atropine is low-dose atropine compounded by local pharmacy.
Axial Length Progression	22 mm Standard Error 0.75

Adverse Events

Multifocal D +2.50 Add & 0.01% Atropine

Serious events: 0 serious events

Other events: 46 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Multifocal D +2.50 Add & 0.01% Atropine n=46 participants at risk The Biofinity Multifocal "D" with a +2.50 add is a soft bifocal contact lens that has a strong reading power; the 0.01% atropine is a low-dose atropine. Multifocal D +2.50 add \& 0.01% atropine: Biofinity Multifocal D +2.50 add is a monthly disposable contact lens commercially available from CooperVision; 0.01% atropine is low-dose atropine compounded by local pharmacy.
Eye disorders Mild eye itching at the drops administering site, which resolved within a few minutes per subjects.	100.0% 46/46 • Three years

Additional Information

Jeffrey Walline

Ohio State University

Phone: 614-247-6840

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place