Cross Linking for Treatment of Corneal Infection

• Sponsor: Price Vision Group (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00912509
• Collaborator: Cornea Research Foundation of America (Other)
• Enrollment: 30
• Location: 1
• Arms: 2
• Duration (Months): 49
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

This study is comparing 45 minute and 30 minute treatment durations with the UVX corneal cross linking system to treat corneal infections.

Condition or Disease	Intervention/Treatment	Phase
Infectious Keratitis	Drug: riboflavin; Device: UVX Light	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Prospective Randomized Double-masked Evaluation of Treatment Duration of the UVX System for Treating Infectious Keratitis
• Study Start Date: May 1, 2009
• Actual Primary Completion Date: Jun 1, 2013
• Actual Study Completion Date: Jun 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 30 minute light duration 30 minute treatment with UVX light	Drug: riboflavin; riboflavin 0.1% is applied every 2 minutes for 30 minutes; Device: UVX Light; UVX 365 nm wavelength light source is applied with continued application of riboflavin 0.1%
Active Comparator: 45 minute light duration 45 minute treatment with UVX light	Device: UVX Light; UVX 365 nm wavelength light source is applied with continued application of riboflavin 0.1%

Outcome Measures

Primary Outcome Measures

1. Time to Re-epithelialization [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]

Secondary Outcome Measures

1. Time to Resolution of Stromal Infiltration [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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 14 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• diagnosis of infectious keratitis

Exclusion Criteria:

• corneal ulcer that has perforated

• corneal ulcer that has produced a descemetocele

• women who are pregnant or breastfeeding

• patients who are immunocompromised or unwilling or unable to comply with a medication regimen

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Price Vision Group	Indianapolis	Indiana	United States	46260

Sponsors and Collaborators

• Price Vision Group
• Cornea Research Foundation of America

Investigators

• Principal Investigator: Francis W Price, MD, Price Vision Group

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Price Vision Group website

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.

• Responsible Party: Price Vision Group
• ClinicalTrials.gov Identifier: NCT00912509
• Other Study ID Numbers: 2008-0143
• First Posted: Jun 3, 2009
• Last Update Posted: Nov 22, 2017
• Last Verified: Oct 1, 2017

• Keywords provided by Price Vision Group: infectious keratitis; cross linking; corneal ulcer; corneal infection; collagen cross linking
• Additional relevant MeSH terms: Communicable Diseases; Infections; Keratitis; Riboflavin

Study Results

Participant Flow

Arm/Group Title	30 Minute Light Duration	45 Minute Light Duration
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

Baseline Characteristics

Arm/Group Title	30 Minute Light Duration	45 Minute Light Duration	Total
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 Participants	20	10	30
Age (Count of Participants)
<=18 years	1 5%	0 0%	1 3.3%
Between 18 and 65 years	13 65%	4 40%	17 56.7%
>=65 years	6 30%	6 60%	12 40%
Sex: Female, Male (Count of Participants)
Female	14 70%	6 60%	20 66.7%
Male	6 30%	4 40%	10 33.3%

Outcome Measures

1. Primary Outcome

Title	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

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 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%
Measure Participants	15	7
Median (Inter-Quartile Range) [Days]	14	11

2. Secondary Outcome

Title	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

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 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%
Measure Participants	15	7
Median (Inter-Quartile Range) [days]	21	10

Adverse Events

Arm/Group Title	30 Minute Light Duration		45 Minute Light Duration
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	30 Minute Light Duration		45 Minute Light Duration
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/10 (0%)
Other (Not Including Serious) Adverse Events
	30 Minute Light Duration		45 Minute Light Duration
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/20 (25%)		4/10 (40%)
Eye disorders
Cornea transplant	4/20 (20%)	4	2/10 (20%)	2
Intracorneal injection of voriconazole	1/20 (5%)	1	1/10 (10%)	1
Dendritic lesions characteristic of prior herpes simplex	0/20 (0%)	0	1/10 (10%)	1

Limitations/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.