Trial Outcomes & Findings for Rose Bengal Electromagnetic Activation With Green Light for Infection Reduction (NCT NCT05110001)
NCT ID: NCT05110001
Last Updated: 2026-01-30
Results Overview
Best Spectacle-Corrected Visual Acuity
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
330 participants
Primary outcome timeframe
6 Months
Results posted on
2026-01-30
Participant Flow
Participant milestones
| Measure |
Standard Therapy
Patients in this arm will receive topical chlorhexidine gluconate 0.02% (acanthamoeba), moxifloxacin 0.5% (smear/culture negative) or natamycin 5% (fungal keratitis) plus sham RB-PDT
Moxifloxacin Ophthalmic: Topical moxifloxacin 0.5% is a fluoroquinolone antibiotic that is used to treat bacterial infections. This is a standard therapy for bacterial keratitis.
Chlorhexidine Gluconate: Topical chlorhexidine gluconate 0.02% is an antiseptic agent, with both antibacterial and antifungal properties. This is a standard therapy for Acanthamoeba keratitis.
Natamycin: Natamycin 5% is an antifungal agent used to treat fungi that cause keratitis. This is a standard therapy for fungal keratitis.
Placebo: Study participants receive sham RB-PDT within 48 hours of randomization. Participants will receive a 30-minute loading dose of topical balanced salt solution which will be applied in 5-minute intervals to the de-epithelialized cornea. A pen light covered with a green filter will be used for 15 minutes. Repeat cornea culture will be collected 30 minutes after the sham procedure.
|
Cross-Linking With Rose Bengal (RB-PDT)
Patients in this arm will receive topical chlorhexidine gluconate 0.02% (acanthamoeba), moxifloxacin 0.5% (smear/culture negative) or natamycin 5% (fungal keratitis) plus RB-PDT
Moxifloxacin Ophthalmic: Topical moxifloxacin 0.5% is a fluoroquinolone antibiotic that is used to treat bacterial infections. This is a standard therapy for bacterial keratitis.
Chlorhexidine Gluconate: Topical chlorhexidine gluconate 0.02% is an antiseptic agent, with both antibacterial and antifungal properties. This is a standard therapy for Acanthamoeba keratitis.
Natamycin: Natamycin 5% is an antifungal agent used to treat fungi that cause keratitis. This is a standard therapy for fungal keratitis.
Rose Bengal: Study participants receive RB-PDT within 48 hours of randomization. All participants will receive a 30-minute loading dose of topical Rose Bengal (0.1% RB in 0.9% sodium chloride) which will be applied in 5-minute intervals to the de-epithelialized cornea. This will be followed by irradiation with a 6mW/cm2 custom-made green LED source for 15 minutes (5.4J/cm2). Repeat cornea culture will be collected within 24 hours after the procedure.
|
|---|---|---|
|
Overall Study
STARTED
|
165
|
165
|
|
Overall Study
COMPLETED
|
149
|
148
|
|
Overall Study
NOT COMPLETED
|
16
|
17
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Rose Bengal Electromagnetic Activation With Green Light for Infection Reduction
Baseline characteristics by cohort
| Measure |
Standard Therapy
n=165 Eyes
Patients in this arm will receive topical chlorhexidine gluconate 0.02% (acanthamoeba), moxifloxacin 0.5% (smear/culture negative) or natamycin 5% (fungal keratitis) plus sham RB-PDT
Moxifloxacin Ophthalmic: Topical moxifloxacin 0.5% is a fluoroquinolone antibiotic that is used to treat bacterial infections. This is a standard therapy for bacterial keratitis.
Chlorhexidine Gluconate: Topical chlorhexidine gluconate 0.02% is an antiseptic agent, with both antibacterial and antifungal properties. This is a standard therapy for Acanthamoeba keratitis.
Natamycin: Natamycin 5% is an antifungal agent used to treat fungi that cause keratitis. This is a standard therapy for fungal keratitis.
Placebo: Study participants receive sham RB-PDT within 48 hours of randomization. Participants will receive a 30-minute loading dose of topical balanced salt solution which will be applied in 5-minute intervals to the de-epithelialized cornea. A pen light covered with a green filter will be used for 15 minutes. Repeat cornea culture will be collected 30 minutes after the sham procedure.
|
Cross-Linking With Rose Bengal (RB-PDT)
n=165 Eyes
Patients in this arm will receive topical chlorhexidine gluconate 0.02% (acanthamoeba), moxifloxacin 0.5% (smear/culture negative) or natamycin 5% (fungal keratitis) plus RB-PDT
Moxifloxacin Ophthalmic: Topical moxifloxacin 0.5% is a fluoroquinolone antibiotic that is used to treat bacterial infections. This is a standard therapy for bacterial keratitis.
Chlorhexidine Gluconate: Topical chlorhexidine gluconate 0.02% is an antiseptic agent, with both antibacterial and antifungal properties. This is a standard therapy for Acanthamoeba keratitis.
Natamycin: Natamycin 5% is an antifungal agent used to treat fungi that cause keratitis. This is a standard therapy for fungal keratitis.
Rose Bengal: Study participants receive RB-PDT within 48 hours of randomization. All participants will receive a 30-minute loading dose of topical Rose Bengal (0.1% RB in 0.9% sodium chloride) which will be applied in 5-minute intervals to the de-epithelialized cornea. This will be followed by irradiation with a 6mW/cm2 custom-made green LED source for 15 minutes (5.4J/cm2). Repeat cornea culture will be collected within 24 hours after the procedure.
|
Total
n=330 Eyes
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50 years
STANDARD_DEVIATION 12 • n=35 Participants
|
50 years
STANDARD_DEVIATION 13 • n=4328 Participants
|
50 years
STANDARD_DEVIATION 13 • n=8687 Participants
|
|
Sex: Female, Male
Female
|
58 Participants
n=35 Participants
|
59 Participants
n=4328 Participants
|
117 Participants
n=8687 Participants
|
|
Sex: Female, Male
Male
|
107 Participants
n=35 Participants
|
106 Participants
n=4328 Participants
|
213 Participants
n=8687 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=35 Participants
|
6 Participants
n=4328 Participants
|
13 Participants
n=8687 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
148 Participants
n=35 Participants
|
150 Participants
n=4328 Participants
|
298 Participants
n=8687 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=35 Participants
|
9 Participants
n=4328 Participants
|
19 Participants
n=8687 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=35 Participants
|
3 Participants
n=4328 Participants
|
3 Participants
n=8687 Participants
|
|
Race (NIH/OMB)
Asian
|
151 Participants
n=35 Participants
|
147 Participants
n=4328 Participants
|
298 Participants
n=8687 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=35 Participants
|
0 Participants
n=4328 Participants
|
0 Participants
n=8687 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=35 Participants
|
1 Participants
n=4328 Participants
|
3 Participants
n=8687 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=35 Participants
|
1 Participants
n=4328 Participants
|
3 Participants
n=8687 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=35 Participants
|
4 Participants
n=4328 Participants
|
6 Participants
n=8687 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=35 Participants
|
9 Participants
n=4328 Participants
|
17 Participants
n=8687 Participants
|
|
Visual Acuity (logMAR BSCVA)
|
1.1 logMar
STANDARD_DEVIATION 0.50 • n=158 Eyes
|
1.2 logMar
STANDARD_DEVIATION 0.51 • n=154 Eyes
|
1.1 logMar
STANDARD_DEVIATION 0.50 • n=312 Eyes
|
|
Central Corneal Thickness (μm)
|
630 μm
STANDARD_DEVIATION 130 • n=158 Eyes
|
650 μm
STANDARD_DEVIATION 130 • n=154 Eyes
|
640 μm
STANDARD_DEVIATION 130 • n=312 Eyes
|
|
Hypopyon
None
|
99 Participants
n=35 Participants
|
87 Participants
n=4328 Participants
|
186 Participants
n=8687 Participants
|
|
Hypopyon
< 0.5 mm
|
14 Participants
n=35 Participants
|
17 Participants
n=4328 Participants
|
31 Participants
n=8687 Participants
|
|
Hypopyon
Other
|
52 Participants
n=35 Participants
|
61 Participants
n=4328 Participants
|
113 Participants
n=8687 Participants
|
|
Infiltrate/Scar Size (mm)
|
3.7 mm
STANDARD_DEVIATION 1.4 • n=158 Eyes
|
3.8 mm
STANDARD_DEVIATION 1.5 • n=154 Eyes
|
3.8 mm
STANDARD_DEVIATION 1.4 • n=312 Eyes
|
|
Fungal Culture (Positive)
|
118 Participants
n=35 Participants
|
115 Participants
n=4328 Participants
|
233 Participants
n=8687 Participants
|
|
Fungal Smear (Positive)
|
142 Participants
n=35 Participants
|
141 Participants
n=4328 Participants
|
283 Participants
n=8687 Participants
|
|
Acanthamoeba Culture
Positive
|
6 Participants
n=35 Participants
|
2 Participants
n=4328 Participants
|
8 Participants
n=8687 Participants
|
|
Acanthamoeba Culture
Negative
|
54 Participants
n=35 Participants
|
54 Participants
n=4328 Participants
|
108 Participants
n=8687 Participants
|
|
Acanthamoeba Culture
Not performed
|
105 Participants
n=35 Participants
|
109 Participants
n=4328 Participants
|
214 Participants
n=8687 Participants
|
|
Acanthamoeba Smear (Postive)
|
4 Participants
n=35 Participants
|
1 Participants
n=4328 Participants
|
5 Participants
n=8687 Participants
|
|
Occupation
Manual Labor-Agriculture
|
84 Participants
n=35 Participants
|
71 Participants
n=4328 Participants
|
155 Participants
n=8687 Participants
|
|
Occupation
Manual Labor- Non-Agriculture
|
41 Participants
n=35 Participants
|
61 Participants
n=4328 Participants
|
102 Participants
n=8687 Participants
|
|
Occupation
Service/Clerical
|
1 Participants
n=35 Participants
|
4 Participants
n=4328 Participants
|
5 Participants
n=8687 Participants
|
|
Occupation
Skilled Labor
|
6 Participants
n=35 Participants
|
5 Participants
n=4328 Participants
|
11 Participants
n=8687 Participants
|
|
Occupation
Business/Trade
|
3 Participants
n=35 Participants
|
1 Participants
n=4328 Participants
|
4 Participants
n=8687 Participants
|
|
Occupation
Domestic (Housework)
|
7 Participants
n=35 Participants
|
2 Participants
n=4328 Participants
|
9 Participants
n=8687 Participants
|
|
Occupation
Student
|
2 Participants
n=35 Participants
|
3 Participants
n=4328 Participants
|
5 Participants
n=8687 Participants
|
|
Occupation
Retired
|
1 Participants
n=35 Participants
|
0 Participants
n=4328 Participants
|
1 Participants
n=8687 Participants
|
|
Occupation
Unemployed
|
15 Participants
n=35 Participants
|
10 Participants
n=4328 Participants
|
25 Participants
n=8687 Participants
|
|
Occupation
Other
|
5 Participants
n=35 Participants
|
8 Participants
n=4328 Participants
|
13 Participants
n=8687 Participants
|
|
Recent Eye Trauma
|
110 Participants
n=35 Participants
|
100 Participants
n=4328 Participants
|
210 Participants
n=8687 Participants
|
|
Contact Menswear
|
4 Participants
n=35 Participants
|
3 Participants
n=4328 Participants
|
7 Participants
n=8687 Participants
|
|
Uses Native Medicine
|
13 Participants
n=35 Participants
|
7 Participants
n=4328 Participants
|
20 Participants
n=8687 Participants
|
|
Symptom Duration (Days)
|
8.0 days
STANDARD_DEVIATION 7.1 • n=35 Participants
|
9.1 days
STANDARD_DEVIATION 8.9 • n=4328 Participants
|
8.5 days
STANDARD_DEVIATION 8.0 • n=8687 Participants
|
PRIMARY outcome
Timeframe: 6 MonthsBest Spectacle-Corrected Visual Acuity
Outcome measures
| Measure |
Standard Therapy
n=149 Participants
Patients in this arm will receive topical chlorhexidine gluconate 0.02% (acanthamoeba), moxifloxacin 0.5% (smear/culture negative) or natamycin 5% (fungal keratitis) plus sham RB-PDT
Moxifloxacin Ophthalmic: Topical moxifloxacin 0.5% is a fluoroquinolone antibiotic that is used to treat bacterial infections. This is a standard therapy for bacterial keratitis.
Chlorhexidine Gluconate: Topical chlorhexidine gluconate 0.02% is an antiseptic agent, with both antibacterial and antifungal properties. This is a standard therapy for Acanthamoeba keratitis.
Natamycin: Natamycin 5% is an antifungal agent used to treat fungi that cause keratitis. This is a standard therapy for fungal keratitis.
Placebo: Study participants receive sham RB-PDT within 48 hours of randomization. Participants will receive a 30-minute loading dose of topical balanced salt solution which will be applied in 5-minute intervals to the de-epithelialized cornea. A pen light covered with a green filter will be used for 15 minutes. Repeat cornea culture will be collected 30 minutes after the sham procedure.
|
Cross-Linking With Rose Bengal (RB-PDT)
n=148 Participants
Patients in this arm will receive topical chlorhexidine gluconate 0.02% (acanthamoeba), moxifloxacin 0.5% (smear/culture negative) or natamycin 5% (fungal keratitis) plus RB-PDT
Moxifloxacin Ophthalmic: Topical moxifloxacin 0.5% is a fluoroquinolone antibiotic that is used to treat bacterial infections. This is a standard therapy for bacterial keratitis.
Chlorhexidine Gluconate: Topical chlorhexidine gluconate 0.02% is an antiseptic agent, with both antibacterial and antifungal properties. This is a standard therapy for Acanthamoeba keratitis.
Natamycin: Natamycin 5% is an antifungal agent used to treat fungi that cause keratitis. This is a standard therapy for fungal keratitis.
Rose Bengal: Study participants receive RB-PDT within 48 hours of randomization. All participants will receive a 30-minute loading dose of topical Rose Bengal (0.1% RB in 0.9% sodium chloride) which will be applied in 5-minute intervals to the de-epithelialized cornea. This will be followed by irradiation with a 6mW/cm2 custom-made green LED source for 15 minutes (5.4J/cm2). Repeat cornea culture will be collected within 24 hours after the procedure.
|
|---|---|---|
|
Best Spectacle-Corrected Visual Acuity
|
0.614 logMAR
Standard Deviation 0.658
|
0.666 logMAR
Standard Deviation 0.675
|
SECONDARY outcome
Timeframe: 3 Weeks, 3 Months, 12 MonthsPopulation: Loss to follow up
Best Spectacle-Corrected Visual Acuity
Outcome measures
| Measure |
Standard Therapy
n=165 Participants
Patients in this arm will receive topical chlorhexidine gluconate 0.02% (acanthamoeba), moxifloxacin 0.5% (smear/culture negative) or natamycin 5% (fungal keratitis) plus sham RB-PDT
Moxifloxacin Ophthalmic: Topical moxifloxacin 0.5% is a fluoroquinolone antibiotic that is used to treat bacterial infections. This is a standard therapy for bacterial keratitis.
Chlorhexidine Gluconate: Topical chlorhexidine gluconate 0.02% is an antiseptic agent, with both antibacterial and antifungal properties. This is a standard therapy for Acanthamoeba keratitis.
Natamycin: Natamycin 5% is an antifungal agent used to treat fungi that cause keratitis. This is a standard therapy for fungal keratitis.
Placebo: Study participants receive sham RB-PDT within 48 hours of randomization. Participants will receive a 30-minute loading dose of topical balanced salt solution which will be applied in 5-minute intervals to the de-epithelialized cornea. A pen light covered with a green filter will be used for 15 minutes. Repeat cornea culture will be collected 30 minutes after the sham procedure.
|
Cross-Linking With Rose Bengal (RB-PDT)
n=165 Participants
Patients in this arm will receive topical chlorhexidine gluconate 0.02% (acanthamoeba), moxifloxacin 0.5% (smear/culture negative) or natamycin 5% (fungal keratitis) plus RB-PDT
Moxifloxacin Ophthalmic: Topical moxifloxacin 0.5% is a fluoroquinolone antibiotic that is used to treat bacterial infections. This is a standard therapy for bacterial keratitis.
Chlorhexidine Gluconate: Topical chlorhexidine gluconate 0.02% is an antiseptic agent, with both antibacterial and antifungal properties. This is a standard therapy for Acanthamoeba keratitis.
Natamycin: Natamycin 5% is an antifungal agent used to treat fungi that cause keratitis. This is a standard therapy for fungal keratitis.
Rose Bengal: Study participants receive RB-PDT within 48 hours of randomization. All participants will receive a 30-minute loading dose of topical Rose Bengal (0.1% RB in 0.9% sodium chloride) which will be applied in 5-minute intervals to the de-epithelialized cornea. This will be followed by irradiation with a 6mW/cm2 custom-made green LED source for 15 minutes (5.4J/cm2). Repeat cornea culture will be collected within 24 hours after the procedure.
|
|---|---|---|
|
Best Spectacle-Corrected Visual Acuity
3-week
|
0.821 logMAR
Standard Deviation 0.630
|
0.855 logMAR
Standard Deviation 0.617
|
|
Best Spectacle-Corrected Visual Acuity
3-month
|
0.700 logMAR
Standard Deviation 0.661
|
0.772 logMAR
Standard Deviation 0.673
|
|
Best Spectacle-Corrected Visual Acuity
12- month
|
0.531 logMAR
Standard Deviation 0.662
|
0.611 logMAR
Standard Deviation 0.669
|
SECONDARY outcome
Timeframe: 3 Weeks, 3 Months, 6 Months 12 MonthsPopulation: Loss to follow up or CP/TPK
Geometric Mean
Outcome measures
| Measure |
Standard Therapy
n=135 Eyes
Patients in this arm will receive topical chlorhexidine gluconate 0.02% (acanthamoeba), moxifloxacin 0.5% (smear/culture negative) or natamycin 5% (fungal keratitis) plus sham RB-PDT
Moxifloxacin Ophthalmic: Topical moxifloxacin 0.5% is a fluoroquinolone antibiotic that is used to treat bacterial infections. This is a standard therapy for bacterial keratitis.
Chlorhexidine Gluconate: Topical chlorhexidine gluconate 0.02% is an antiseptic agent, with both antibacterial and antifungal properties. This is a standard therapy for Acanthamoeba keratitis.
Natamycin: Natamycin 5% is an antifungal agent used to treat fungi that cause keratitis. This is a standard therapy for fungal keratitis.
Placebo: Study participants receive sham RB-PDT within 48 hours of randomization. Participants will receive a 30-minute loading dose of topical balanced salt solution which will be applied in 5-minute intervals to the de-epithelialized cornea. A pen light covered with a green filter will be used for 15 minutes. Repeat cornea culture will be collected 30 minutes after the sham procedure.
|
Cross-Linking With Rose Bengal (RB-PDT)
n=133 Eyes
Patients in this arm will receive topical chlorhexidine gluconate 0.02% (acanthamoeba), moxifloxacin 0.5% (smear/culture negative) or natamycin 5% (fungal keratitis) plus RB-PDT
Moxifloxacin Ophthalmic: Topical moxifloxacin 0.5% is a fluoroquinolone antibiotic that is used to treat bacterial infections. This is a standard therapy for bacterial keratitis.
Chlorhexidine Gluconate: Topical chlorhexidine gluconate 0.02% is an antiseptic agent, with both antibacterial and antifungal properties. This is a standard therapy for Acanthamoeba keratitis.
Natamycin: Natamycin 5% is an antifungal agent used to treat fungi that cause keratitis. This is a standard therapy for fungal keratitis.
Rose Bengal: Study participants receive RB-PDT within 48 hours of randomization. All participants will receive a 30-minute loading dose of topical Rose Bengal (0.1% RB in 0.9% sodium chloride) which will be applied in 5-minute intervals to the de-epithelialized cornea. This will be followed by irradiation with a 6mW/cm2 custom-made green LED source for 15 minutes (5.4J/cm2). Repeat cornea culture will be collected within 24 hours after the procedure.
|
|---|---|---|
|
Scar Size
3-weeks
|
3.84 mm
Standard Deviation 1.64
|
3.37 mm
Standard Deviation 1.35
|
|
Scar Size
3-months
|
3.99 mm
Standard Deviation 1.61
|
3.71 mm
Standard Deviation 1.52
|
|
Scar Size
6-months
|
3.96 mm
Standard Deviation 1.63
|
3.73 mm
Standard Deviation 1.53
|
|
Scar Size
12-months
|
3.65 mm
Standard Deviation 1.62
|
3.64 mm
Standard Deviation 1.43
|
Adverse Events
Standard Therapy
Serious events: 31 serious events
Other events: 17 other events
Deaths: 1 deaths
Cross-Linking With Rose Bengal (RB-PDT)
Serious events: 36 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Standard Therapy
n=165 participants at risk
Patients in this arm will receive topical chlorhexidine gluconate 0.02% (acanthamoeba), moxifloxacin 0.5% (smear/culture negative) or natamycin 5% (fungal keratitis) plus sham RB-PDT
Moxifloxacin Ophthalmic: Topical moxifloxacin 0.5% is a fluoroquinolone antibiotic that is used to treat bacterial infections. This is a standard therapy for bacterial keratitis.
Chlorhexidine Gluconate: Topical chlorhexidine gluconate 0.02% is an antiseptic agent, with both antibacterial and antifungal properties. This is a standard therapy for Acanthamoeba keratitis.
Natamycin: Natamycin 5% is an antifungal agent used to treat fungi that cause keratitis. This is a standard therapy for fungal keratitis.
Placebo: Study participants receive sham RB-PDT within 48 hours of randomization. Participants will receive a 30-minute loading dose of topical balanced salt solution which will be applied in 5-minute intervals to the de-epithelialized cornea. A pen light covered with a green filter will be used for 15 minutes. Repeat cornea culture will be collected 30 minutes after the sham procedure.
|
Cross-Linking With Rose Bengal (RB-PDT)
n=165 participants at risk
Patients in this arm will receive topical chlorhexidine gluconate 0.02% (acanthamoeba), moxifloxacin 0.5% (smear/culture negative) or natamycin 5% (fungal keratitis) plus RB-PDT
Moxifloxacin Ophthalmic: Topical moxifloxacin 0.5% is a fluoroquinolone antibiotic that is used to treat bacterial infections. This is a standard therapy for bacterial keratitis.
Chlorhexidine Gluconate: Topical chlorhexidine gluconate 0.02% is an antiseptic agent, with both antibacterial and antifungal properties. This is a standard therapy for Acanthamoeba keratitis.
Natamycin: Natamycin 5% is an antifungal agent used to treat fungi that cause keratitis. This is a standard therapy for fungal keratitis.
Rose Bengal: Study participants receive RB-PDT within 48 hours of randomization. All participants will receive a 30-minute loading dose of topical Rose Bengal (0.1% RB in 0.9% sodium chloride) which will be applied in 5-minute intervals to the de-epithelialized cornea. This will be followed by irradiation with a 6mW/cm2 custom-made green LED source for 15 minutes (5.4J/cm2). Repeat cornea culture will be collected within 24 hours after the procedure.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Non-elective surgery, hospitalization, or loss of function
|
0.00%
0/165 • 12 months
|
0.61%
1/165 • 12 months
|
|
Eye disorders
Therapeutic Penetrating Keratoplasty
|
12.1%
20/165 • 12 months
|
17.6%
29/165 • 12 months
|
|
Eye disorders
Corneal perforation
|
1.2%
2/165 • 12 months
|
1.2%
2/165 • 12 months
|
|
Eye disorders
Therapeutic Penetrating Keratoplasty and Corneal Perforation
|
5.5%
9/165 • 12 months
|
2.4%
4/165 • 12 months
|
Other adverse events
| Measure |
Standard Therapy
n=165 participants at risk
Patients in this arm will receive topical chlorhexidine gluconate 0.02% (acanthamoeba), moxifloxacin 0.5% (smear/culture negative) or natamycin 5% (fungal keratitis) plus sham RB-PDT
Moxifloxacin Ophthalmic: Topical moxifloxacin 0.5% is a fluoroquinolone antibiotic that is used to treat bacterial infections. This is a standard therapy for bacterial keratitis.
Chlorhexidine Gluconate: Topical chlorhexidine gluconate 0.02% is an antiseptic agent, with both antibacterial and antifungal properties. This is a standard therapy for Acanthamoeba keratitis.
Natamycin: Natamycin 5% is an antifungal agent used to treat fungi that cause keratitis. This is a standard therapy for fungal keratitis.
Placebo: Study participants receive sham RB-PDT within 48 hours of randomization. Participants will receive a 30-minute loading dose of topical balanced salt solution which will be applied in 5-minute intervals to the de-epithelialized cornea. A pen light covered with a green filter will be used for 15 minutes. Repeat cornea culture will be collected 30 minutes after the sham procedure.
|
Cross-Linking With Rose Bengal (RB-PDT)
n=165 participants at risk
Patients in this arm will receive topical chlorhexidine gluconate 0.02% (acanthamoeba), moxifloxacin 0.5% (smear/culture negative) or natamycin 5% (fungal keratitis) plus RB-PDT
Moxifloxacin Ophthalmic: Topical moxifloxacin 0.5% is a fluoroquinolone antibiotic that is used to treat bacterial infections. This is a standard therapy for bacterial keratitis.
Chlorhexidine Gluconate: Topical chlorhexidine gluconate 0.02% is an antiseptic agent, with both antibacterial and antifungal properties. This is a standard therapy for Acanthamoeba keratitis.
Natamycin: Natamycin 5% is an antifungal agent used to treat fungi that cause keratitis. This is a standard therapy for fungal keratitis.
Rose Bengal: Study participants receive RB-PDT within 48 hours of randomization. All participants will receive a 30-minute loading dose of topical Rose Bengal (0.1% RB in 0.9% sodium chloride) which will be applied in 5-minute intervals to the de-epithelialized cornea. This will be followed by irradiation with a 6mW/cm2 custom-made green LED source for 15 minutes (5.4J/cm2). Repeat cornea culture will be collected within 24 hours after the procedure.
|
|---|---|---|
|
Eye disorders
Increase in hypopyon (increase >2mm)
|
3.6%
6/165 • 12 months
|
4.2%
7/165 • 12 months
|
|
Eye disorders
Increase in the longest diameter of infiltrate (>50% increase from baseline and >1mm)
|
6.1%
10/165 • 12 months
|
8.5%
14/165 • 12 months
|
|
Eye disorders
Progressive corneal thinning, < 50% of enrollment thickness
|
0.61%
1/165 • 12 months
|
1.8%
3/165 • 12 months
|
|
Eye disorders
Other
|
0.00%
0/165 • 12 months
|
0.61%
1/165 • 12 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place