Trial Outcomes & Findings for Myopia Progression After Ceasing Myopia Control Contact Lens Wear (NCT NCT01829230)

Results Overview

Axial length was measured with the IOLMaster at baseline and then every 6 months throughout the course of the study. Five measurements were collected at each visit from the subject's right eye and the average of the 5 measurements was used for the analysis.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

82 participants

Primary outcome timeframe

Baseline and every 6 months post-baseline up to 18 months

Results posted on

2018-06-19

Participant Flow

Participant milestones

Participant milestones
Measure	Test Lens C Test lens C from previous study	Test Lens A Test lens A from previous study
Overall Study STARTED	40	42
Overall Study COMPLETED	39	38
Overall Study NOT COMPLETED	1	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Test Lens C Test lens C from previous study	Test Lens A Test lens A from previous study
Overall Study Protocol Violation	0	2
Overall Study Withdrawal by Subject	0	1
Overall Study Lost to Follow-up	1	1

Baseline Characteristics

Myopia Progression After Ceasing Myopia Control Contact Lens Wear

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Test Lens C n=40 Participants Test lens C from previous study	Test Lens A n=42 Participants Test lens A from previous study	Total n=82 Participants Total of all reporting groups
Age, Categorical <=18 years	40 Participants n=5 Participants	42 Participants n=7 Participants	82 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	11.1 years STANDARD_DEVIATION 1.2 • n=5 Participants	11.0 years STANDARD_DEVIATION 1.2 • n=7 Participants	11.1 years STANDARD_DEVIATION 1.2 • n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants	24 Participants n=7 Participants	46 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	18 Participants n=7 Participants	36 Participants n=5 Participants
Region of Enrollment United States	40 participants n=5 Participants	42 participants n=7 Participants	82 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and every 6 months post-baseline up to 18 months

Population: All subjects who have at least one data point.

Axial length was measured with the IOLMaster at baseline and then every 6 months throughout the course of the study. Five measurements were collected at each visit from the subject's right eye and the average of the 5 measurements was used for the analysis.

Outcome measures

Outcome measures
Measure	Test Lens C n=40 Participants Test lens C from the previous study	Test Lens A n=41 Participants Test lens A from the previous study
Axial Length of the Eye Change from baseline at 6 months	0.080 millimeter (mm) Standard Deviation 0.0822	0.073 millimeter (mm) Standard Deviation 0.0661
Axial Length of the Eye Change from baseline at 12 months	0.229 millimeter (mm) Standard Deviation 0.1237	0.231 millimeter (mm) Standard Deviation 0.1181
Axial Length of the Eye Change from baseline at 18 months	0.272 millimeter (mm) Standard Deviation 0.1656	0.255 millimeter (mm) Standard Deviation 0.1611

PRIMARY outcome

Timeframe: Baseline and every 6 months up to 18 months

Population: All subjects who have at least one data point.

Cycloplegic spherical equivalent refraction of the subjects's right eye was computed from the sphero-cylindrical refraction measured with an open-field auto refractor. The median of 5 repeated measurements, each of which was the average of 3 consecutive readings, was used for the analysis.

Outcome measures

Outcome measures
Measure	Test Lens C n=41 Participants Test lens C from the previous study	Test Lens A n=40 Participants Test lens A from the previous study
Spherical Equivalent Refractive Error Change from baseline at 6 months	-0.015 diopter (D) Standard Deviation 0.1911	-0.155 diopter (D) Standard Deviation 0.2101
Spherical Equivalent Refractive Error Change from baseline at 12 months	-0.342 diopter (D) Standard Deviation 0.3136	-0.471 diopter (D) Standard Deviation 0.2991
Spherical Equivalent Refractive Error Change from baseline at 18 months	-0.444 diopter (D) Standard Deviation 0.3866	-0.569 diopter (D) Standard Deviation 0.3718

Adverse Events

Test Lens C

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Test Lens A

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

XU CHENG, PRINCIPAL CLINICAL SCIENTIST

Vistakon USA

Phone: 1 904 443-1245

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place