Trial Outcomes & Findings for Bifocal Soft Contact Lenses and Their Effect on Myopia Progression in Children and Adolescents. (NCT NCT00214487)

NCT ID: NCT00214487

Last Updated: 2014-07-22

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 78 participants
• Primary outcome timeframe: One year
• Results posted on: 2014-07-22

Participant Flow

Participant milestones

Measure	Bifocal Contact Lenses Use of bifocal contact lenses to control the progression of myopia Bifocal Contact Lenses: Use of bifocal contact lenses of varying add powers to control the progression of myopia	Control Single vision soft contact lenses Placebo Control: Single vision soft contact lenses
Overall Study STARTED	43	43
Overall Study COMPLETED	38	40
Overall Study NOT COMPLETED	5	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Bifocal Soft Contact Lenses and Their Effect on Myopia Progression in Children and Adolescents.

Baseline characteristics by cohort

Measure	Bifocal Contact Lenses n=38 Participants Use of bifocal contact lenses to control the progression of myopia Bifocal Contact Lenses: Use of bifocal contact lenses of varying add powers to control the progression of myopia	Control n=40 Participants Single vision soft contact lenses Placebo Control: Single vision soft contact lenses	Total n=78 Participants Total of all reporting groups
Age, Categorical <=18 years	38 Participants n=5 Participants	40 Participants n=7 Participants	78 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
Sex: Female, Male Female	27 Participants n=5 Participants	27 Participants n=7 Participants	54 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	13 Participants n=7 Participants	24 Participants n=5 Participants

PRIMARY outcome

Timeframe: One year

Outcome measures

Measure	Bifocal Contact Lenses n=38 Participants Use of bifocal contact lenses to control the progression of myopia Bifocal Contact Lenses: Use of bifocal contact lenses of varying add powers to control the progression of myopia	Control n=40 Participants Single vision soft contact lenses Placebo Control: Single vision soft contact lenses
Changes in Cycloplegic Autorefraction in One Year.	-0.22 Diopters Standard Deviation 0.34	-0.78 Diopters Standard Deviation 0.45

SECONDARY outcome

Timeframe: One year

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: One year

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: One year

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: One year

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: One year

Outcome measures

Outcome data not reported

Adverse Events

Bifocal Contact Lenses

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

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

Dr. Thomas Aller

Dr. Thomas Aller, Optometrist Inc.

Phone: 650 871-1816

Email: cptreyes@earthlink.net

Results disclosure agreements

• Principal investigator is a sponsor employee The Investigator acknowledges that the data to be collected is proprietary. The Investigator agrees not to publish, divulge, reveal, disclose or otherwise make available, the data to others without the permission of sponsor unless the data have already been, or are subsequently published or disclosed by order of a court of law. The Investigator will not be free to publish papers dealing with the results of any Research performed under this Agreement without the consent of sponsor.
• Publication restrictions are in place

Restriction type: OTHER