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

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	30 Minute Light Duration	45 Minute Light Duration
Arm/Group Description	30 minute treatment with UVX light ...	45 minute treatment with UVX light ...
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

Baseline Characteristics

Arm/Group Title		30 Minute Light Duration	45 Minute Light Duration	Total
Arm/Group Description		30 minute treatment with UVX light ...	45 minute treatment with UVX light ...	Total of all reporting groups
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
Baseline Analysis Population Description		...
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%

Outcome Measures

1.Primary Outcome


Title	Time to Re-epithelialization
Description	[Not Specified]
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

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	30 Minute Light Duration	45 Minute Light Duration
Arm/Group Description:	30 minute treatment with UVX light ...	45 minute treatment with UVX light ...
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
Description	[Not Specified]
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

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	30 Minute Light Duration	45 Minute Light Duration
Arm/Group Description:	30 minute treatment with UVX light ...	45 minute treatment with UVX light ...
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)

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]

Arm/Group Title	30 Minute Light Duration		45 Minute Light Duration
Arm/Group Description	30 minute treatment with UVX light ...		45 minute treatment with UVX light ...
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	--/--		--/--
Serious Adverse Events 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%)
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

Limitations and Caveats

[Not Specified]

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

Layout table for Results Point of Contact information

Name/Title:	Marianne O. Price, PhD
Organization:	Cornea Research Foundation of America
Phone:	317-814-2990
EMail:	mprice@cornea.org

Publications of Results:

Price MO, Tenkman LR, Schrier A, Fairchild KM, Trokel SL, Price FW Jr. Photoactivated riboflavin treatment of infectious keratitis using collagen cross-linking technology. J Refract Surg. 2012 Oct;28(10):706-13. doi: 10.3928/1081597X-20120921-06.

Other Publications:

Iseli HP, Thiel MA, Hafezi F, Kampmeier J, Seiler T. Ultraviolet A/riboflavin corneal cross-linking for infectious keratitis associated with corneal melts. Cornea. 2008 Jun;27(5):590-4. doi: 10.1097/ICO.0b013e318169d698.

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

Davis SA, Bovelle R, Han G, Kwagyan J. Corneal collagen cross-linking for bacterial infectious keratitis. Cochrane Database Syst Rev. 2020 Jun 17;6:CD013001. doi: 10.1002/14651858.CD013001.pub2.

Layout table for additonal information

Responsible Party:	Price Vision Group
ClinicalTrials.gov Identifier:	NCT00912509
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

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