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Cross Linking for Treatment of Corneal Infection

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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
Enrollment 30
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 30 Minute Light Duration 45 Minute Light Duration
Hide Arm/Group Description

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 treatment with UVX light

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

Period Title: Overall Study
Started 20 10
Completed 15 7
Not Completed 5 3
Reason Not Completed
Lost to Follow-up             1             0
Lack of Efficacy             4             3
Arm/Group Title 30 Minute Light Duration 45 Minute Light Duration Total
Hide Arm/Group Description

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 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 of all reporting groups
Overall Number of Baseline Participants 20 10 30
Hide Baseline Analysis Population Description
This is the number of participants who were culture-positive
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 10 participants 30 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  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 10 participants 30 participants
Female
14
  70.0%
6
  60.0%
20
  66.7%
Male
6
  30.0%
4
  40.0%
10
  33.3%
1.Primary Outcome
Title Time to Re-epithelialization
Hide Description [Not Specified]
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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 30 Minute Light Duration 45 Minute Light Duration
Hide Arm/Group Description:

30 minute treatment with UVX light

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

45 minute treatment with UVX light

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

Overall Number of Participants Analyzed 15 7
Median (Inter-Quartile Range)
Unit of Measure: Days
14
(6 to 28)
11
(6 to 29)
2.Secondary Outcome
Title Time to Resolution of Stromal Infiltration
Hide Description [Not Specified]
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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 30 Minute Light Duration 45 Minute Light Duration
Hide Arm/Group Description:

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 treatment with UVX light

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

Overall Number of Participants Analyzed 15 7
Median (Inter-Quartile Range)
Unit of Measure: days
21
(8 to 33)
10
(7 to 11)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 30 Minute Light Duration 45 Minute Light Duration
Hide Arm/Group Description

30 minute treatment with UVX light

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

45 minute treatment with UVX light

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

All-Cause Mortality
30 Minute Light Duration 45 Minute Light Duration
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
30 Minute Light Duration 45 Minute Light Duration
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/20 (0.00%)      0/10 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
30 Minute Light Duration 45 Minute Light Duration
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/20 (25.00%)      4/10 (40.00%)    
Eye disorders     
Cornea transplant   4/20 (20.00%)  4 2/10 (20.00%)  2
Intracorneal injection of voriconazole   1/20 (5.00%)  1 1/10 (10.00%)  1
Dendritic lesions characteristic of prior herpes simplex  0/20 (0.00%)  0 1/10 (10.00%)  1
Indicates events were collected by systematic assessment
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
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