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

This study has been completed.
Sponsor:
Collaborator:
Vistakon
Information provided by (Responsible Party):
Thomas A. Aller, OD, Aller, Thomas A., OD
ClinicalTrials.gov Identifier:
NCT00214487
First received: September 14, 2005
Last updated: June 23, 2014
Last verified: June 2014
Results First Received: June 23, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions: Myopia
Esophoria
Fixation Disparity
Interventions: Device: Bifocal Contact Lenses
Device: Placebo Control

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
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


Participant Flow:   Overall Study
    Bifocal Contact Lenses     Control  
STARTED     43     43  
COMPLETED     38     40  
NOT COMPLETED     5     3  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Numbers reflect those subjects screened, enrolled, randomized with at least one follow up examination.

Reporting Groups
  Description
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

Total Total of all reporting groups

Baseline Measures
    Bifocal Contact Lenses     Control     Total  
Number of Participants  
[units: participants]
  38     40     78  
Age  
[units: participants]
     
<=18 years     38     40     78  
Between 18 and 65 years     0     0     0  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     27     27     54  
Male     11     13     24  



  Outcome Measures

1.  Primary:   Changes in Cycloplegic Autorefraction in One Year.   [ Time Frame: One year ]

2.  Secondary:   Keratometric Changes at One Year.   [ Time Frame: One year ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Changes in Manifest Refraction at One Year.   [ Time Frame: One year ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Relationship Between Residual Fixation Disparity and Myopia Progression.   [ Time Frame: One year ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Changes in Cycloplegic Subjective Refraction in One Year   [ Time Frame: One year ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Changes in Axial Length at One Year.   [ Time Frame: One year ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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 agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Dr. Thomas Aller
Organization: Dr. Thomas Aller, Optometrist Inc.
phone: 650 871-1816
e-mail: 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.

Other Publications:

Responsible Party: Thomas A. Aller, OD, Aller, Thomas A., OD
ClinicalTrials.gov Identifier: NCT00214487     History of Changes
Other Study ID Numbers: CR-0107
Study First Received: September 14, 2005
Results First Received: June 23, 2014
Last Updated: June 23, 2014
Health Authority: United States: Food and Drug Administration