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Corneal Collagen Cross-linking for Progressive Keratoconus (CXL)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Avedro, Inc.
ClinicalTrials.gov Identifier:
NCT00647699
First received: March 28, 2008
Last updated: June 14, 2016
Last verified: June 2016
Results First Received: May 2, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Progressive Keratoconus
Interventions: Drug: riboflavin ophthalmic solution
Device: UVA Irradiation

  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
Corneal Collagen Cross-linking (CXL) Treatment Group riboflavin ophthalmic solution and UVA irradiation (365 nm at an irradiance of 3 mW/cm2) for 30 minutes
Control Group riboflavin ophthalmic solution without UVA irradiation

Participant Flow:   Overall Study
    Corneal Collagen Cross-linking (CXL) Treatment Group     Control Group  
STARTED     73     74  
COMPLETED     65     62  
NOT COMPLETED     8     12  
Lost to Follow-up                 5                 4  
Withdrawal by Subject                 3                 8  



  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.
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Reporting Groups
  Description
Corneal Collagen Cross-linking (CXL) Treatment Group riboflavin ophthalmic solution and UVA irradiation (365 nm at an irradiance of 3 mW/cm2) for 30 minutes
Control Group riboflavin ophthalmic solution without UVA irradiation
Total Total of all reporting groups

Baseline Measures
    Corneal Collagen Cross-linking (CXL) Treatment Group     Control Group     Total  
Number of Participants  
[units: participants]
  73     74     147  
Age  
[units: participants]
     
<=18 years     7     3     10  
Between 18 and 65 years     66     71     137  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     19     24     43  
Male     54     50     104  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     7     3     10  
Not Hispanic or Latino     31     36     67  
Unknown or Not Reported     35     35     70  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     0     1     1  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     7     7     14  
White     54     61     115  
More than one race     0     0     0  
Unknown or Not Reported     12     5     17  



  Outcome Measures

1.  Primary:   Mean Change From Baseline in Maximum Keratometry (Kmax)   [ Time Frame: baseline,12 months ]


  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: Vineeta Belanger, VP of Clinical Affairs
Organization: Avedro, Inc.
phone: 781-768-3459
e-mail: vbelanger@avedro.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Avedro, Inc.
ClinicalTrials.gov Identifier: NCT00647699     History of Changes
Other Study ID Numbers: UVX-002
Study First Received: March 28, 2008
Results First Received: May 2, 2016
Last Updated: June 14, 2016
Health Authority: United States: Food and Drug Administration