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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Infectious Keratitis | Drug: riboflavin Device: UVX Light | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
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 2009 |
Actual Primary Completion Date : | June 2013 |
Actual Study Completion Date : | June 2013 |

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% |
- 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 ]
- 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 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 14 Years and older (Child, Adult, Older Adult) |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00912509
United States, Indiana | |
Price Vision Group | |
Indianapolis, Indiana, United States, 46260 |
Principal Investigator: | Francis W Price, MD | Price Vision Group |
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Price Vision Group |
ClinicalTrials.gov Identifier: | NCT00912509 |
Other Study ID Numbers: |
2008-0143 |
First Posted: | June 3, 2009 Key Record Dates |
Results First Posted: | August 22, 2014 |
Last Update Posted: | November 22, 2017 |
Last Verified: | October 2017 |
infectious keratitis cross linking corneal ulcer corneal infection collagen cross linking |
Communicable Diseases Infection Keratitis Corneal Diseases Eye Diseases Riboflavin Vitamin B Complex |
Vitamins Micronutrients Nutrients Growth Substances Physiological Effects of Drugs Photosensitizing Agents Dermatologic Agents |