Trial Outcomes & Findings for Controlling Myopia Progression With Soft Contact Lenses (Contact Lens Control) (NCT NCT01829191)

Results Overview

Cycloplegic spherical equivalent auto refraction of the subject's right eye was computed from the sphero-cylindrical refraction measured with an open-field auto refractor. The median of 3 repeated measures, each of which was the average of 3 consecutive readings, was used for the analysis. Higher values in spherical refraction indicate progression in Myopia.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

174 participants

Primary outcome timeframe

Baseline and every 6 months post-baseline for 2 years

Results posted on

2018-06-19

Participant Flow

Of those 174 screened subjects, 42 were ineligible to participate in the study and 5 eligible subjects did not randomize to the study arm.

Participant milestones

Participant milestones
Measure	Test Lens A Test lenses will be worn in a daily wear modality	Test Lens C Test lens will be worn in a daily wear modality
Overall Study STARTED	63	64
Overall Study COMPLETED	56	50
Overall Study NOT COMPLETED	7	14

Reasons for withdrawal

Reasons for withdrawal
Measure	Test Lens A Test lenses will be worn in a daily wear modality	Test Lens C Test lens will be worn in a daily wear modality
Overall Study Relocation	0	1
Overall Study Lens discomfort	0	3
Overall Study Lens handling difficulty	1	4
Overall Study Protocol Violation	4	1
Overall Study Withdrawal by Subject	2	3
Overall Study Lost to Follow-up	0	1
Overall Study Subject was fit for ortho - k	0	1

Baseline Characteristics

Controlling Myopia Progression With Soft Contact Lenses (Contact Lens Control)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Test Lens A n=63 Participants Test lenses will be worn in a daily wear modality	Test Lens C n=64 Participants Test lens will be worn in a daily wear modality	Total n=127 Participants Total of all reporting groups
Age, Categorical <=18 years	63 Participants n=5 Participants	64 Participants n=7 Participants	127 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	9.7 years STANDARD_DEVIATION 1.1 • n=5 Participants	9.7 years STANDARD_DEVIATION 1.1 • n=7 Participants	9.7 years STANDARD_DEVIATION 1.1 • n=5 Participants
Sex: Female, Male Female	34 Participants n=5 Participants	34 Participants n=7 Participants	68 Participants n=5 Participants
Sex: Female, Male Male	29 Participants n=5 Participants	30 Participants n=7 Participants	59 Participants n=5 Participants
Region of Enrollment United States	63 Participants n=5 Participants	64 Participants n=7 Participants	127 Participants n=5 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.

Cycloplegic spherical equivalent auto refraction of the subject's right eye was computed from the sphero-cylindrical refraction measured with an open-field auto refractor. The median of 3 repeated measures, each of which was the average of 3 consecutive readings, was used for the analysis. Higher values in spherical refraction indicate progression in Myopia.

Outcome measures

Outcome measures
Measure	Test Lens A n=59 Participants Test lenses will be worn in a daily wear modality	Test Lens C n=53 Participants Test lenses will be worn in a daily wear modality
Spherical Equivalent Refractive Error Change from baseline 6 months	-0.386 diopter (D) Standard Error 0.3270	-0.185 diopter (D) Standard Error 0.2873
Spherical Equivalent Refractive Error Change from baseline 12 months	-0.679 diopter (D) Standard Error 0.5253	-0.548 diopter (D) Standard Error 0.4050
Spherical Equivalent Refractive Error Change from baseline 18 months	-0.934 diopter (D) Standard Error 0.4761	-0.614 diopter (D) Standard Error 0.4140
Spherical Equivalent Refractive Error Change from baseline 24 months	-1.054 diopter (D) Standard Error 0.4559	-1.080 diopter (D) Standard Error 0.6800

SECONDARY outcome

Timeframe: Baseline and every 6 months 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 for 2 years. Five measurements were collected for each visit from the subject's right eye and the average of the five measurements was used for the analysis.

Outcome measures

Outcome measures
Measure	Test Lens A n=59 Participants Test lenses will be worn in a daily wear modality	Test Lens C n=53 Participants Test lenses will be worn in a daily wear modality
Axial Length Change from baseline 6 months	0.172 millimeter (mm) Standard Deviation 0.1029	0.061 millimeter (mm) Standard Deviation 0.1038
Axial Length Change from baseline 12 months	0.371 millimeter (mm) Standard Deviation 0.1471	0.229 millimeter (mm) Standard Deviation 0.1581
Axial Length Change from baseline 18 months	0.479 millimeter (mm) Standard Deviation 0.2049	0.313 millimeter (mm) Standard Deviation 0.1946
Axial Length Change from baseline 24 months	0.545 millimeter (mm) Standard Deviation 0.2177	0.514 millimeter (mm) Standard Deviation 0.2808

Adverse Events

All Subjects

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