Trial Outcomes & Findings for Corneal Collagen Cross-linking for Progressive Keratoconus (NCT NCT00647699)
NCT ID: NCT00647699
Last Updated: 2021-04-26
Results Overview
The primary efficacy parameter was corneal curvature, as measured by maximum keratometry (Kmax) in the study eyes. Study success was defined as a difference of ≥1 D in the mean change in Kmax from baseline to 12 months between the CXL group and control group. Keratometry was measured manually and by pentacam.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
147 participants
Primary outcome timeframe
baseline,12 months
Results posted on
2021-04-26
Participant Flow
Participant milestones
| Measure |
Corneal Collagen Cross-linking (CXL) Treatment Group
riboflavin ophthalmic solution and UVA irradiation (365 nm at an irradiance of 3 mW/cm2) for 30 minutes
|
Control Group
riboflavin ophthalmic solution without UVA irradiation
|
|---|---|---|
|
Overall Study
STARTED
|
73
|
74
|
|
Overall Study
COMPLETED
|
65
|
62
|
|
Overall Study
NOT COMPLETED
|
8
|
12
|
Reasons for withdrawal
| Measure |
Corneal Collagen Cross-linking (CXL) Treatment Group
riboflavin ophthalmic solution and UVA irradiation (365 nm at an irradiance of 3 mW/cm2) for 30 minutes
|
Control Group
riboflavin ophthalmic solution without UVA irradiation
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
4
|
|
Overall Study
Withdrawal by Subject
|
3
|
8
|
Baseline Characteristics
Corneal Collagen Cross-linking for Progressive Keratoconus
Baseline characteristics by cohort
| Measure |
Corneal Collagen Cross-linking (CXL) Treatment Group
n=73 Participants
riboflavin ophthalmic solution and UVA irradiation (365 nm at an irradiance of 3 mW/cm2) for 30 minutes
|
Control Group
n=74 Participants
riboflavin ophthalmic solution without UVA irradiation
|
Total
n=147 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
7 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
66 Participants
n=99 Participants
|
71 Participants
n=107 Participants
|
137 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
43 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=99 Participants
|
50 Participants
n=107 Participants
|
104 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
31 Participants
n=99 Participants
|
36 Participants
n=107 Participants
|
67 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
35 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
70 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
54 Participants
n=99 Participants
|
61 Participants
n=107 Participants
|
115 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
12 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: baseline,12 monthsPopulation: The ITT (intent to treat) population consisted of all treated subjects, analyzed according to the treatment actually received. For the sham study eyes that received CXL treatment after baseline, the last Kmax measurement recorded prior to receiving CXL treatment was used in the analysis for later time points.
The primary efficacy parameter was corneal curvature, as measured by maximum keratometry (Kmax) in the study eyes. Study success was defined as a difference of ≥1 D in the mean change in Kmax from baseline to 12 months between the CXL group and control group. Keratometry was measured manually and by pentacam.
Outcome measures
| Measure |
Corneal Collagen Cross-linking (CXL) Treatment Group
n=73 Participants
riboflavin ophthalmic solution and UVA irradiation (365 nm at an irradiance of 3 mW/cm2) for 30 minutes
|
Control Group
n=74 Participants
riboflavin ophthalmic solution without UVA irradiation
|
|---|---|---|
|
Mean Change From Baseline in Maximum Keratometry (Kmax)
|
-1.7 diopters
Standard Deviation 4.7
|
0.6 diopters
Standard Deviation 2.8
|
Adverse Events
Corneal Collagen Cross-linking (CXL) Treatment Group
Serious events: 0 serious events
Other events: 57 other events
Deaths: 0 deaths
Control Group
Serious events: 3 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Corneal Collagen Cross-linking (CXL) Treatment Group
n=73 participants at risk
riboflavin ophthalmic solution and UVA irradiation (365 nm at an irradiance of 3 mW/cm2) for 30 minutes
|
Control Group
n=74 participants at risk
riboflavin ophthalmic solution without UVA irradiation
|
|---|---|---|
|
Eye disorders
ulcerative keratitis
|
0.00%
0/73 • 3 months
|
1.4%
1/74 • Number of events 1 • 3 months
|
|
Infections and infestations
Appendicitis
|
0.00%
0/73 • 3 months
|
1.4%
1/74 • Number of events 1 • 3 months
|
|
Injury, poisoning and procedural complications
infectious cat bite
|
0.00%
0/73 • 3 months
|
1.4%
1/74 • Number of events 1 • 3 months
|
Other adverse events
| Measure |
Corneal Collagen Cross-linking (CXL) Treatment Group
n=73 participants at risk
riboflavin ophthalmic solution and UVA irradiation (365 nm at an irradiance of 3 mW/cm2) for 30 minutes
|
Control Group
n=74 participants at risk
riboflavin ophthalmic solution without UVA irradiation
|
|---|---|---|
|
Eye disorders
Corneal opacity
|
47.9%
35/73 • Number of events 43 • 3 months
|
1.4%
1/74 • Number of events 1 • 3 months
|
|
Eye disorders
Eye pain
|
17.8%
13/73 • Number of events 13 • 3 months
|
4.1%
3/74 • Number of events 3 • 3 months
|
|
Eye disorders
Punctate keratitis
|
17.8%
13/73 • Number of events 16 • 3 months
|
10.8%
8/74 • Number of events 8 • 3 months
|
|
Eye disorders
Corneal striae
|
15.1%
11/73 • Number of events 11 • 3 months
|
6.8%
5/74 • Number of events 5 • 3 months
|
|
Eye disorders
Corneal epithelial defect
|
13.7%
10/73 • Number of events 11 • 3 months
|
1.4%
1/74 • Number of events 1 • 3 months
|
|
Eye disorders
Vision blurred
|
12.3%
9/73 • Number of events 12 • 3 months
|
1.4%
1/74 • Number of events 1 • 3 months
|
|
Eye disorders
Conjunctival hyperaemia
|
9.6%
7/73 • Number of events 7 • 3 months
|
1.4%
1/74 • Number of events 1 • 3 months
|
|
Eye disorders
Photophobia
|
8.2%
6/73 • Number of events 6 • 3 months
|
0.00%
0/74 • 3 months
|
|
Eye disorders
Eyelid oedema
|
6.8%
5/73 • Number of events 5 • 3 months
|
0.00%
0/74 • 3 months
|
|
Eye disorders
Visual acuity reduced
|
6.8%
5/73 • Number of events 5 • 3 months
|
8.1%
6/74 • Number of events 8 • 3 months
|
|
Eye disorders
Dry Eye
|
5.5%
4/73 • Number of events 5 • 3 months
|
2.7%
2/74 • Number of events 2 • 3 months
|
|
Eye disorders
Eye irritation
|
5.5%
4/73 • Number of events 4 • 3 months
|
1.4%
1/74 • Number of events 1 • 3 months
|
|
Eye disorders
Eye oedema
|
5.5%
4/73 • Number of events 4 • 3 months
|
0.00%
0/74 • 3 months
|
|
Eye disorders
Anterior chamber flare
|
4.1%
3/73 • Number of events 3 • 3 months
|
0.00%
0/74 • 3 months
|
|
Eye disorders
Corneal disorder
|
4.1%
3/73 • Number of events 3 • 3 months
|
0.00%
0/74 • 3 months
|
|
Eye disorders
Lacrimation increased
|
4.1%
3/73 • Number of events 3 • 3 months
|
0.00%
0/74 • 3 months
|
|
Eye disorders
Corneal oedema
|
2.7%
2/73 • Number of events 2 • 3 months
|
0.00%
0/74 • 3 months
|
|
Eye disorders
Diplopia
|
2.7%
2/73 • Number of events 2 • 3 months
|
1.4%
1/74 • Number of events 1 • 3 months
|
|
Eye disorders
Foreign body sensation in eye
|
2.7%
2/73 • Number of events 2 • 3 months
|
0.00%
0/74 • 3 months
|
|
Eye disorders
Glare
|
2.7%
2/73 • Number of events 2 • 3 months
|
1.4%
1/74 • Number of events 1 • 3 months
|
|
Eye disorders
Ocular hyperaemia
|
2.7%
2/73 • Number of events 2 • 3 months
|
1.4%
1/74 • Number of events 1 • 3 months
|
|
Eye disorders
Visual impairment
|
2.7%
2/73 • Number of events 2 • 3 months
|
1.4%
1/74 • Number of events 1 • 3 months
|
|
Eye disorders
Corneal scar
|
2.7%
2/73 • Number of events 2 • 3 months
|
2.7%
2/74 • Number of events 2 • 3 months
|
|
Nervous system disorders
Headache
|
2.7%
2/73 • Number of events 2 • 3 months
|
0.00%
0/74 • 3 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Site has the right to publish or communicate study results upon the earlier of: (a) publication of a multi-center publication of the Study results coordinated by Sponsor; or (b) submission of the Study data by Sponsor to the FDA; provided that the Sponsor reviews the proposed communication of results within ninety (90) days in advance of its release. Sponsor can request delay of publication or data release to allow for filing of patent application prior to the publication or release.
- Publication restrictions are in place
Restriction type: OTHER