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ClinicalTrials.gov Identifier: NCT00912509
Recruitment Status : Terminated (insufficient efficacy)
First Posted : June 3, 2009
Results First Posted : August 22, 2014
Last Update Posted : November 22, 2017
Sponsor:
Collaborator:
Cornea Research Foundation of America
Information provided by (Responsible Party):
Price Vision Group

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Infectious Keratitis
Interventions: Drug: riboflavin
Device: UVX Light

  Participant Flow

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
No text entered.

Reporting Groups
  Description
30 Minute Light Duration

30 minute treatment with UVX light

riboflavin: riboflavin 0.1% is applied every 2 minutes for 30 minutes

UVX Light: UVX 365 nm wavelength light source is applied with continued application of riboflavin 0.1%

45 Minute Light Duration

45 minute treatment with UVX light

UVX Light: UVX 365 nm wavelength light source is applied with continued application of riboflavin 0.1%


Participant Flow:   Overall Study
    30 Minute Light Duration   45 Minute Light Duration
STARTED   20   10 
COMPLETED   15   7 
NOT COMPLETED   5   3 
Lost to Follow-up                1                0 
Lack of Efficacy                4                3 



  Baseline Characteristics

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.
This is the number of participants who were culture-positive

Reporting Groups
  Description
30 Minute Light Duration

30 minute treatment with UVX light

riboflavin: riboflavin 0.1% is applied every 2 minutes for 30 minutes

UVX Light: UVX 365 nm wavelength light source is applied with continued application of riboflavin 0.1%

45 Minute Light Duration

45 minute treatment with UVX light

riboflavin: riboflavin 0.1% is applied every 2 minutes for 30 minutes

UVX Light: UVX 365 nm wavelength light source is applied with continued application of riboflavin 0.1%

Total Total of all reporting groups

Baseline Measures
   30 Minute Light Duration   45 Minute Light Duration   Total 
Overall Participants Analyzed 
[Units: Participants]
 20   10   30 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      1   5.0%      0   0.0%      1   3.3% 
Between 18 and 65 years      13  65.0%      4  40.0%      17  56.7% 
>=65 years      6  30.0%      6  60.0%      12  40.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      14  70.0%      6  60.0%      20  66.7% 
Male      6  30.0%      4  40.0%      10  33.3% 


  Outcome Measures

1.  Primary:   Time to Re-epithelialization   [ Time Frame: Day 1, day 2, day 3, day 4, day 5, day 6, day 7, week 2, and subsequent weekly assessments until re-epithelialization is complete ]

2.  Secondary:   Time to Resolution of Stromal Infiltration   [ Time Frame: day 1, day 2, day 3, day 4, day 5, day 6, day 7, week 2, and subsequent weekly assessments until infiltrate is completely resolved ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Marianne O. Price, PhD
Organization: Cornea Research Foundation of America
phone: 317-814-2990
e-mail: mprice@cornea.org


Publications of Results:
Other Publications:

Responsible Party: Price Vision Group
ClinicalTrials.gov Identifier: NCT00912509     History of Changes
Other Study ID Numbers: 2008-0143
First Submitted: May 30, 2009
First Posted: June 3, 2009
Results First Submitted: August 4, 2014
Results First Posted: August 22, 2014
Last Update Posted: November 22, 2017