Trial Outcomes & Findings for Study to Evaluate the Safety and Efficacy of Epi-on Corneal Cross-linking in Eyes With Progressive Keratoconus (NCT NCT03442751)
NCT ID: NCT03442751
Last Updated: 2024-01-30
Results Overview
Mean difference of at least 1 diopter in Kmax change from baseline to Month 6 between treatment groups
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
201 participants
Primary outcome timeframe
6 months
Results posted on
2024-01-30
Participant Flow
Subjects were recruited at eye clinics and were required to meet inclusion/exclusion criteria prior to enrollment
280 eyes of 201 subjects were randomized in a 2:1 treatment allocation. Of the 280 randomized eyes, 279 were treated: 189 eyes of 156 subjects received CXL treatment \& 90 eyes of 83 subjects received Sham/Control, for a total of 239 treatments. Of the 201 unique subjects, 118 received CXL only (in 1 or both eyes), 45 received Sham/Control only (in 1 or both eyes), and 38 subjects received CXL in 1 eye and Sham/Control in the other eye.
Unit of analysis: eyes
Participant milestones
| Measure |
Epithelium-on CXL Treatment Group
Study eye receives riboflavin ophthalmic solution A, riboflavin ophthalmic solution B and irradiated using KXL High Power System Riboflavin Ophthalmic Solution A Riboflavin Ophthalmic Solution B: KXL High Power System
|
Sham Treatment/Control Group
Sham eye receives Placebo (the vehicle of Riboflavin Ophthalmic Solution) and Mock UVA light source
Placebo KXL High Power System providing mock UVA light source
|
|---|---|---|
|
Overall Study
STARTED
|
156 189
|
83 90
|
|
Overall Study
Month 6
|
153 186
|
82 89
|
|
Overall Study
Month 12
|
150 183
|
0 0
|
|
Overall Study
COMPLETED
|
150 183
|
82 89
|
|
Overall Study
NOT COMPLETED
|
6 6
|
1 1
|
Reasons for withdrawal
| Measure |
Epithelium-on CXL Treatment Group
Study eye receives riboflavin ophthalmic solution A, riboflavin ophthalmic solution B and irradiated using KXL High Power System Riboflavin Ophthalmic Solution A Riboflavin Ophthalmic Solution B: KXL High Power System
|
Sham Treatment/Control Group
Sham eye receives Placebo (the vehicle of Riboflavin Ophthalmic Solution) and Mock UVA light source
Placebo KXL High Power System providing mock UVA light source
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
|
Overall Study
Lost to Follow-up
|
3
|
0
|
Baseline Characteristics
Study to Evaluate the Safety and Efficacy of Epi-on Corneal Cross-linking in Eyes With Progressive Keratoconus
Baseline characteristics by cohort
| Measure |
Epithelium-on CXL Treatment Group
n=189 Eyes
Study eye receives riboflavin ophthalmic solution A, riboflavin ophthalmic solution B and irradiated using KXL High Power System
Riboflavin Ophthalmic Solution A Riboflavin Ophthalmic Solution B: KXL High Power System
|
Sham Treatment/Control Group
n=90 Eyes
Sham eye receives Placebo (the vehicle of Riboflavin Ophthalmic Solution) and Mock UVA light source
Placebo KXL High Power System providing mock UVA light source
|
Total
n=279 Eyes
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
30.0 years
STANDARD_DEVIATION 9.75 • n=99 Participants
|
29.5 years
STANDARD_DEVIATION 9.67 • n=107 Participants
|
30.0 years
STANDARD_DEVIATION 9.9 • n=206 Participants
|
|
Sex/Gender, Customized
Male
|
109 participants
n=99 Participants
|
55 participants
n=107 Participants
|
139 participants
n=206 Participants
|
|
Sex/Gender, Customized
Female
|
47 participants
n=99 Participants
|
28 participants
n=107 Participants
|
62 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Ethnicity: Hispanic or Latino
|
28 participants
n=99 Participants
|
68 participants
n=107 Participants
|
36 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Ethnicity: Not Hispanic or Latino
|
128 participants
n=99 Participants
|
15 participants
n=107 Participants
|
165 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race: Asian
|
3 participants
n=99 Participants
|
4 participants
n=107 Participants
|
5 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race: Black or African American
|
27 participants
n=99 Participants
|
18 participants
n=107 Participants
|
36 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race: Native Hawaiian or Other Pacific Islander
|
3 participants
n=99 Participants
|
1 participants
n=107 Participants
|
3 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race: White
|
112 participants
n=99 Participants
|
54 participants
n=107 Participants
|
142 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race: Other
|
11 participants
n=99 Participants
|
6 participants
n=107 Participants
|
15 participants
n=206 Participants
|
|
Mean Kmax (D)
|
59.4 Diopters
STANDARD_DEVIATION 9.1 • n=117 Eyes
|
59.3 Diopters
STANDARD_DEVIATION 9.1 • n=115 Eyes
|
59.4 Diopters
STANDARD_DEVIATION 9.1 • n=232 Eyes
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Intent-to-treat analysis set which included all randomized study eyes that had at least one post-treatment follow-up efficacy assessment. Missing post-baseline Kmax data were imputed using multiple imputation.
Mean difference of at least 1 diopter in Kmax change from baseline to Month 6 between treatment groups
Outcome measures
| Measure |
Epithelium-on CXL Treatment Group
n=189 eyes
Study eye receives riboflavin ophthalmic solution A, riboflavin ophthalmic solution B and irradiated using KXL High Power System
Riboflavin Ophthalmic Solution A Riboflavin Ophthalmic Solution B: KXL High Power System
|
Sham Treatment/Control Group
n=90 eyes
Sham eye receives Placebo (the vehicle of Riboflavin Ophthalmic Solution) and Mock UVA light source
Placebo KXL High Power System providing mock UVA light source
|
|---|---|---|
|
Difference Between Treatment Groups in the Change From Baseline to Month 6 in Kmax
|
-0.3 Diopters
Interval -0.6 to 0.0
|
0.6 Diopters
Interval 0.2 to 1.1
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Intent-to-treat analysis set which included all randomized study eyes that had at least one post-treatment follow-up efficacy assessment. Missing post-baseline Kmax data were imputed.
Difference between the CXL and Sham/Control treatment groups in the change from baseline to Month 12 in Kmax
Outcome measures
| Measure |
Epithelium-on CXL Treatment Group
n=189 eyes
Study eye receives riboflavin ophthalmic solution A, riboflavin ophthalmic solution B and irradiated using KXL High Power System
Riboflavin Ophthalmic Solution A Riboflavin Ophthalmic Solution B: KXL High Power System
|
Sham Treatment/Control Group
n=90 eyes
Sham eye receives Placebo (the vehicle of Riboflavin Ophthalmic Solution) and Mock UVA light source
Placebo KXL High Power System providing mock UVA light source
|
|---|---|---|
|
Difference Between Treatment Groups in the Change From Baseline to Month 12 in Kmax
|
-0.4 Diopters
Interval -0.7 to -0.2
|
0.7 Diopters
Interval 0.3 to 1.1
|
Adverse Events
Ocular: Epithelium-on CXL Treatment Group
Serious events: 1 serious events
Other events: 170 other events
Deaths: 0 deaths
Ocular: Sham Treatment/Control Group
Serious events: 0 serious events
Other events: 63 other events
Deaths: 0 deaths
Non-ocular: Epithelium-on
Serious events: 2 serious events
Other events: 1 other events
Deaths: 0 deaths
Non-ocular: Sham Treatment/Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Non-ocular: Epithelium-on and Sham Treatment
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ocular: Epithelium-on CXL Treatment Group
n=189 participants at risk
Study eye received riboflavin ophthalmic solution A, riboflavin ophthalmic solution B and irradiated using KXL High Power System
|
Ocular: Sham Treatment/Control Group
n=90 participants at risk
Sham eye received Placebo (the vehicle of Riboflavin Ophthalmic Solution) and Mock UVA light source
|
Non-ocular: Epithelium-on
n=118 participants at risk
Participant eye(s) treated only with this intervention (i.e., riboflavin ophthalmic solution A, riboflavin ophthalmic solution B and irradiated using KXL High Power System)
|
Non-ocular: Sham Treatment/Control
n=45 participants at risk
Participant eye(s) treated only with this intervention (i.e., Placebo \[the vehicle of riboflavin ophthalmic solution\] and Mock UVA light source)
|
Non-ocular: Epithelium-on and Sham Treatment
n=38 participants at risk
Participant had one eye treated with Epithelium-on CXL (i.e., riboflavin ophthalmic solution A, riboflavin ophthalmic solution B and irradiated using KXL High Power System) and one eye treated with Sham (i.e., Placebo \[the vehicle of riboflavin ophthalmic solution\] and Mock UVA light source)
|
|---|---|---|---|---|---|
|
Renal and urinary disorders
Urinary tract infection
|
—
0/0 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
—
0/0 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
0.85%
1/118 • Number of events 1 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
0.00%
0/45 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
0.00%
0/38 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
|
Renal and urinary disorders
Kidney infection
|
—
0/0 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
0.00%
0/90 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
0.85%
1/118 • Number of events 1 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
0.00%
0/45 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
0.00%
0/38 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
|
Reproductive system and breast disorders
Uterine leiomyoma
|
0.00%
0/189 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
0.00%
0/90 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
0.00%
0/118 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
0.00%
0/45 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
2.6%
1/38 • Number of events 1 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
|
Psychiatric disorders
Depression suicidal
|
0.00%
0/189 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
0.00%
0/90 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
0.85%
1/118 • Number of events 1 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
0.00%
0/45 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
0.00%
0/38 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
|
Eye disorders
Cataract subcapsular
|
0.53%
1/189 • Number of events 2 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
0.00%
0/90 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
0.00%
0/118 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
0.00%
0/45 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
0.00%
0/38 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
|
Eye disorders
Retinal detachment
|
0.53%
1/189 • Number of events 2 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
0.00%
0/90 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
0.00%
0/118 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
0.00%
0/45 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
0.00%
0/38 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
|
Eye disorders
Corneal opacity
|
0.53%
1/189 • Number of events 1 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
0.00%
0/90 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
0.00%
0/118 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
0.00%
0/45 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
0.00%
0/38 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
Other adverse events
| Measure |
Ocular: Epithelium-on CXL Treatment Group
n=189 participants at risk
Study eye received riboflavin ophthalmic solution A, riboflavin ophthalmic solution B and irradiated using KXL High Power System
|
Ocular: Sham Treatment/Control Group
n=90 participants at risk
Sham eye received Placebo (the vehicle of Riboflavin Ophthalmic Solution) and Mock UVA light source
|
Non-ocular: Epithelium-on
n=118 participants at risk
Participant eye(s) treated only with this intervention (i.e., riboflavin ophthalmic solution A, riboflavin ophthalmic solution B and irradiated using KXL High Power System)
|
Non-ocular: Sham Treatment/Control
n=45 participants at risk
Participant eye(s) treated only with this intervention (i.e., Placebo \[the vehicle of riboflavin ophthalmic solution\] and Mock UVA light source)
|
Non-ocular: Epithelium-on and Sham Treatment
n=38 participants at risk
Participant had one eye treated with Epithelium-on CXL (i.e., riboflavin ophthalmic solution A, riboflavin ophthalmic solution B and irradiated using KXL High Power System) and one eye treated with Sham (i.e., Placebo \[the vehicle of riboflavin ophthalmic solution\] and Mock UVA light source)
|
|---|---|---|---|---|---|
|
Eye disorders
Conjunctival hyperaemia
|
60.8%
115/189 • Number of events 120 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
27.8%
25/90 • Number of events 27 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
0.00%
0/118 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
0.00%
0/45 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
0.00%
0/38 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
|
Eye disorders
Corneal opacity
|
40.7%
77/189 • Number of events 97 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
12.2%
11/90 • Number of events 11 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
0.00%
0/118 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
0.00%
0/45 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
0.00%
0/38 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
|
Eye disorders
Photophobia
|
38.6%
73/189 • Number of events 90 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
13.3%
12/90 • Number of events 12 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
0.00%
0/118 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
0.00%
0/45 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
0.00%
0/38 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
|
Eye disorders
Punctate keratitis
|
34.9%
66/189 • Number of events 84 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
30.0%
27/90 • Number of events 30 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
0.00%
0/118 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
0.00%
0/45 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
0.00%
0/38 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
|
Eye disorders
Eye pain
|
32.3%
61/189 • Number of events 70 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
5.6%
5/90 • Number of events 5 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
0.00%
0/118 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
0.00%
0/45 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
0.00%
0/38 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
|
Eye disorders
Eye irritation
|
31.2%
59/189 • Number of events 66 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
7.8%
7/90 • Number of events 7 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
0.00%
0/118 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
0.00%
0/45 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
0.00%
0/38 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
|
Eye disorders
Lacrimation increased
|
19.0%
36/189 • Number of events 37 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
1.1%
1/90 • Number of events 1 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
0.00%
0/118 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
0.00%
0/45 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
0.00%
0/38 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
|
Eye disorders
Corneal epithelium defect
|
14.8%
28/189 • Number of events 34 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
0.00%
0/90 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
0.00%
0/118 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
0.00%
0/45 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
0.00%
0/38 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
|
Eye disorders
Corneal striae
|
13.8%
26/189 • Number of events 27 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
4.4%
4/90 • Number of events 4 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
0.00%
0/118 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
0.00%
0/45 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
0.00%
0/38 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
|
Eye disorders
Dry eye
|
11.6%
22/189 • Number of events 23 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
2.2%
2/90 • Number of events 2 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
0.00%
0/118 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
0.00%
0/45 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
0.00%
0/38 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
|
Eye disorders
Visual acuity reduced
|
10.6%
20/189 • Number of events 21 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
6.7%
6/90 • Number of events 6 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
0.00%
0/118 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
0.00%
0/45 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
0.00%
0/38 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
|
Eye disorders
Anterior chamber flare
|
10.6%
20/189 • Number of events 21 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
1.1%
1/90 • Number of events 1 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
0.00%
0/118 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
0.00%
0/45 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
0.00%
0/38 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
|
Eye disorders
Foreign body sensation in eyes
|
9.5%
18/189 • Number of events 20 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
5.6%
5/90 • Number of events 6 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
0.00%
0/118 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
0.00%
0/45 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
0.00%
0/38 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
|
Eye disorders
Vision blurred
|
9.5%
18/189 • Number of events 18 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
4.4%
4/90 • Number of events 6 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
0.00%
0/118 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
0.00%
0/45 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
0.00%
0/38 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
|
Eye disorders
Corneal disorder
|
9.5%
18/189 • Number of events 22 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
0.00%
0/90 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
0.00%
0/118 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
0.00%
0/45 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
0.00%
0/38 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
|
Eye disorders
Corneal warpage
|
6.9%
13/189 • Number of events 14 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
7.8%
7/90 • Number of events 7 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
0.00%
0/118 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
0.00%
0/45 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
0.00%
0/38 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
|
Eye disorders
Eye pruritus
|
5.8%
11/189 • Number of events 12 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
6.7%
6/90 • Number of events 6 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
0.00%
0/118 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
0.00%
0/45 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
0.00%
0/38 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
|
Eye disorders
Corneal thinning
|
5.8%
11/189 • Number of events 11 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
3.3%
3/90 • Number of events 3 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
0.00%
0/118 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
0.00%
0/45 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
0.00%
0/38 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
|
Eye disorders
Anterior chamber cell
|
5.3%
10/189 • Number of events 11 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
1.1%
1/90 • Number of events 1 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
0.00%
0/118 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
0.00%
0/45 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
0.00%
0/38 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
|
Investigations
Vital dye staining cornea present
|
5.8%
11/189 • Number of events 11 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
1.1%
1/90 • Number of events 1 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
0.00%
0/118 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
0.00%
0/45 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
0.00%
0/38 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
|
Eye disorders
Eyelid oedema
|
14.3%
27/189 • Number of events 27 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
2.2%
2/90 • Number of events 2 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
0.00%
0/118 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
0.00%
0/45 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
0.00%
0/38 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/189 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
0.00%
0/90 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
0.85%
1/118 • Number of events 1 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
0.00%
0/45 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
5.3%
2/38 • Number of events 2 • 12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group
For the ocular adverse event arms, the affected and at risk population reflect the number of eyes. For the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place