Trial Outcomes & Findings for Controlling Myopia Progression With Soft Contact Lenses (NCT NCT00762970)

Results Overview

Spherical equivalent refraction was computed from the sphero-cylindrical refraction measured with an open-field auto refractor (WAM-5500) and descriptively summarized for each follow-up. Higher spherical refraction indicates progression in Myopia.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

150 participants

Primary outcome timeframe

Baseline and every 6 months post-baseline for 2 years

Results posted on

2018-06-19

Participant Flow

Of those 150 screened subjects, 3 were not eligible to participate in the study and 10 were not randomized to the study lens groups. 115 subjects completed all study visits without a major protocol deviation.

Participant milestones

Participant milestones
Measure	Test Lens 1 Investigational soft contact lenses worn daily.	Test Lens 2 Investigational soft contact lenses worn daily.	Control Lens Control spectacle lenses worn daily.
Overall Study STARTED	46	44	47
Overall Study COMPLETED	34	35	46
Overall Study NOT COMPLETED	12	9	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Test Lens 1 Investigational soft contact lenses worn daily.	Test Lens 2 Investigational soft contact lenses worn daily.	Control Lens Control spectacle lenses worn daily.
Overall Study Withdrawal by Subject	7	4	0
Overall Study Protocol Violation	3	1	1
Overall Study Lost to Follow-up	1	2	0
Overall Study Difficulty of handling lens	1	2	0

Baseline Characteristics

Controlling Myopia Progression With Soft Contact Lenses

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Test Lens 1 n=46 Participants Investigational soft contact lens worn daily.	Test Lens 2 n=44 Participants Investigational soft contact lens worn daily.	Control Lens n=47 Participants Spectacle lenses worn daily.	Total n=137 Participants Total of all reporting groups
Age, Categorical <=18 years	46 Participants n=93 Participants	44 Participants n=4 Participants	47 Participants n=27 Participants	137 Participants n=483 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Age, Continuous	9.8 years STANDARD_DEVIATION 1.1 • n=93 Participants	9.8 years STANDARD_DEVIATION 1.2 • n=4 Participants	9.7 years STANDARD_DEVIATION 1.2 • n=27 Participants	9.8 years STANDARD_DEVIATION 1.1 • n=483 Participants
Sex: Female, Male Female	30 Participants n=93 Participants	22 Participants n=4 Participants	26 Participants n=27 Participants	78 Participants n=483 Participants
Sex: Female, Male Male	16 Participants n=93 Participants	22 Participants n=4 Participants	21 Participants n=27 Participants	59 Participants n=483 Participants
Region of Enrollment China · Ch	46 Participants n=93 Participants	44 Participants n=4 Participants	47 Participants n=27 Participants	137 Participants n=483 Participants

PRIMARY outcome

Timeframe: Baseline and every 6 months post-baseline for 2 years

Population: Analysis was conducted on all randomized subjects who have at least one data point.

Spherical equivalent refraction was computed from the sphero-cylindrical refraction measured with an open-field auto refractor (WAM-5500) and descriptively summarized for each follow-up. Higher spherical refraction indicates progression in Myopia.

Outcome measures

Outcome measures
Measure	Test Lens 1 n=70 eyes Investigational soft contact lenses worn daily.	Test Lens 2 n=74 eyes Investigational soft contact lenses worn daily.	Control Lens n=92 eyes Spectacle lenses worn daily.
Spherical Equivalent Refraction Change from baseline 6 months	-0.326 diopter (D) Standard Deviation 0.6678	-0.460 diopter (D) Standard Deviation 0.3938	-0.430 diopter (D) Standard Deviation 0.3942
Spherical Equivalent Refraction Change from baseline 12 months	-0.898 diopter (D) Standard Deviation 0.4695	-0.859 diopter (D) Standard Deviation 0.4955	-0.905 diopter (D) Standard Deviation 0.5918
Spherical Equivalent Refraction Change from baseline 18 months	-1.222 diopter (D) Standard Deviation 0.8501	-1.185 diopter (D) Standard Deviation 0.6550	-1.336 diopter (D) Standard Deviation 0.7361
Spherical Equivalent Refraction Change from baseline 24 months	-1.506 diopter (D) Standard Deviation 0.9346	-1.376 diopter (D) Standard Deviation 0.5891	-1.809 diopter (D) Standard Deviation 0.9485

PRIMARY outcome

Timeframe: Baseline and every 6 months post-baseline for 2 years

Population: Analysis was conducted on all randomized subjects who have at least one data point.

Axial length was measured with the IOLMaster at baseline and every 6 months post-baseline for 2 years. Axial length was descriptively summarized for each follow-up.

Outcome measures

Outcome measures
Measure	Test Lens 1 n=35 Participants Investigational soft contact lenses worn daily.	Test Lens 2 n=37 Participants Investigational soft contact lenses worn daily.	Control Lens n=46 Participants Spectacle lenses worn daily.
Axial Length (Axial Elongation) Change from baseline 6 months	0.214 millimeter (mm) Standard Deviation 0.1020	0.198 millimeter (mm) Standard Deviation 0.1128	0.263 millimeter (mm) Standard Deviation 0.1766
Axial Length (Axial Elongation) Change from baseline 12 months	0.401 millimeter (mm) Standard Deviation 0.1816	0.382 millimeter (mm) Standard Deviation 0.1974	0.458 millimeter (mm) Standard Deviation 0.2323
Axial Length (Axial Elongation) Change from baseline 18 months	0.564 millimeter (mm) Standard Deviation 0.2371	0.522 millimeter (mm) Standard Deviation 0.2643	0.622 millimeter (mm) Standard Deviation 0.2805
Axial Length (Axial Elongation) Change from baseline 24 months	0.660 millimeter (mm) Standard Deviation 0.2355	0.529 millimeter (mm) Standard Deviation 0.2378	0.749 millimeter (mm) Standard Deviation 0.3203

Adverse Events

Test Lens 1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Test Lens 2

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Lens

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