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

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ClinicalTrials.gov Identifier: NCT00214487
Recruitment Status : Completed
First Posted : September 22, 2005
Results First Posted : July 22, 2014
Last Update Posted : July 22, 2014
Sponsor:
Collaborator:
Johnson & Johnson Vision Care, Inc.
Information provided by (Responsible Party):
Thomas A. Aller, OD, Aller, Thomas A., OD

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions Myopia
Esophoria
Fixation Disparity
Interventions Device: Bifocal Contact Lenses
Device: Placebo Control
Enrollment 78
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Bifocal Contact Lenses Control
Hide Arm/Group Description

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

Single vision soft contact lenses

Placebo Control: Single vision soft contact lenses

Period Title: Overall Study
Started 43 43
Completed 38 40
Not Completed 5 3
Arm/Group Title Bifocal Contact Lenses Control Total
Hide Arm/Group Description

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

Single vision soft contact lenses

Placebo Control: Single vision soft contact lenses

Total of all reporting groups
Overall Number of Baseline Participants 38 40 78
Hide Baseline Analysis Population Description
Numbers reflect those subjects screened, enrolled, randomized with at least one follow up examination.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants 40 participants 78 participants
<=18 years
38
 100.0%
40
 100.0%
78
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants 40 participants 78 participants
Female
27
  71.1%
27
  67.5%
54
  69.2%
Male
11
  28.9%
13
  32.5%
24
  30.8%
1.Primary Outcome
Title Changes in Cycloplegic Autorefraction in One Year.
Hide Description [Not Specified]
Time Frame One year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bifocal Contact Lenses Control
Hide Arm/Group Description:

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

Single vision soft contact lenses

Placebo Control: Single vision soft contact lenses

Overall Number of Participants Analyzed 38 40
Mean (Standard Deviation)
Unit of Measure: Diopters
-0.22  (0.34) -0.78  (0.45)
2.Secondary Outcome
Title Keratometric Changes at One Year.
Hide Description [Not Specified]
Time Frame One year
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Changes in Manifest Refraction at One Year.
Hide Description [Not Specified]
Time Frame One year
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Relationship Between Residual Fixation Disparity and Myopia Progression.
Hide Description [Not Specified]
Time Frame One year
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Changes in Cycloplegic Subjective Refraction in One Year
Hide Description [Not Specified]
Time Frame One year
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Changes in Axial Length at One Year.
Hide Description [Not Specified]
Time Frame One year
Outcome Measure Data Not Reported
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Bifocal Contact Lenses Control
Hide Arm/Group Description

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

Single vision soft contact lenses

Placebo Control: Single vision soft contact lenses

All-Cause Mortality
Bifocal Contact Lenses Control
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Bifocal Contact Lenses Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/38 (0.00%)   0/40 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Bifocal Contact Lenses Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/38 (0.00%)   0/40 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Thomas Aller
Organization: Dr. Thomas Aller, Optometrist Inc.
Phone: 650 871-1816
EMail: cptreyes@earthlink.net
Publications of Results:
Aller TA, Wildsoet C. Results of a one-year prospective clinical trial (CONTROL) of the use of bifocal soft contact lenses to control myopia progression. Ophthalmic and Physiological Optics 26(S1), 8-9.
Layout table for additonal information
Responsible Party: Thomas A. Aller, OD, Aller, Thomas A., OD
ClinicalTrials.gov Identifier: NCT00214487     History of Changes
Other Study ID Numbers: CR-0107
First Submitted: September 14, 2005
First Posted: September 22, 2005
Results First Submitted: June 23, 2014
Results First Posted: July 22, 2014
Last Update Posted: July 22, 2014