Trial Outcomes & Findings for Intracanalicular Dexamethasone Insert for Post-Corneal Cross-Linking Inflammation and Pain- The LINK Study (NCT NCT04168112)
NCT ID: NCT04168112
Last Updated: 2024-01-30
Results Overview
Utilizing the standardized Wong-Baker visual analog pain scale, graded from 0 to 10 (no pain to increasingly worse pain (worst at 10/10))
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
20 participants
Primary outcome timeframe
Assessed at 1 day of surgery, postoperative days 1 ,3, 7, postoperative weeks 2 ,3 and 4 (7 visits total)
Results posted on
2024-01-30
Participant Flow
Participant milestones
| Measure |
Group A
Intracanalicular dexamethasone insert is placed on day of crosslinking (CXL); patients will still receive postoperative fluoroquinolone (or other class in case of allergy) antibiotic eye drops with instructions for use (i.e. 1 drop in operative eye QID x 10 days).
Dextenza: Placement of intracanalicular dexamethasone insert for post-crosslinking inflammation and pain
|
Group B
Patients are placed on standard postoperative regimen of postoperative fluoroquinolone (or other class in case of allergy) antibiotic eye drops with instructions for use (i.e. 1 drop in operative eye QID x 10 days) and Prednisolone acetate 1% ophthalmic solution tapered over 1 month in the following schedule: QID x1 week, TID x 1 week, BID x 1 week, and Qday x 1 week.
Prednisolone Acetate: post-crosslinking eye drop prednisolone acetate given in a tapering schedule over 1 month
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
8
|
10
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Group A
Intracanalicular dexamethasone insert is placed on day of crosslinking (CXL); patients will still receive postoperative fluoroquinolone (or other class in case of allergy) antibiotic eye drops with instructions for use (i.e. 1 drop in operative eye QID x 10 days).
Dextenza: Placement of intracanalicular dexamethasone insert for post-crosslinking inflammation and pain
|
Group B
Patients are placed on standard postoperative regimen of postoperative fluoroquinolone (or other class in case of allergy) antibiotic eye drops with instructions for use (i.e. 1 drop in operative eye QID x 10 days) and Prednisolone acetate 1% ophthalmic solution tapered over 1 month in the following schedule: QID x1 week, TID x 1 week, BID x 1 week, and Qday x 1 week.
Prednisolone Acetate: post-crosslinking eye drop prednisolone acetate given in a tapering schedule over 1 month
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Group A
n=10 Participants
Intracanalicular dexamethasone insert is placed on day of crosslinking (CXL); patients will still receive postoperative fluoroquinolone (or other class in case of allergy) antibiotic eye drops with instructions for use (i.e. 1 drop in operative eye QID x 10 days).
Dextenza: Placement of intracanalicular dexamethasone insert for post-crosslinking inflammation and pain
|
Group B
n=10 Participants
Patients are placed on standard postoperative regimen of postoperative fluoroquinolone (or other class in case of allergy) antibiotic eye drops with instructions for use (i.e. 1 drop in operative eye QID x 10 days) and Prednisolone acetate 1% ophthalmic solution tapered over 1 month in the following schedule: QID x1 week, TID x 1 week, BID x 1 week, and Qday x 1 week.
Prednisolone Acetate: post-crosslinking eye drop prednisolone acetate given in a tapering schedule over 1 month
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=10 Participants
|
10 Participants
n=10 Participants
|
20 Participants
n=20 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Age, Continuous
|
26 years
STANDARD_DEVIATION 3.89 • n=10 Participants
|
36.3 years
STANDARD_DEVIATION 10.29 • n=10 Participants
|
31.15 years
STANDARD_DEVIATION 5.15 • n=20 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=10 Participants
|
4 Participants
n=10 Participants
|
10 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=10 Participants
|
6 Participants
n=10 Participants
|
10 Participants
n=20 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
10 participants
n=10 Participants
|
10 participants
n=10 Participants
|
20 participants
n=20 Participants
|
PRIMARY outcome
Timeframe: Assessed at 1 day of surgery, postoperative days 1 ,3, 7, postoperative weeks 2 ,3 and 4 (7 visits total)Population: By POD7, no patient complained of pain or discomfort (i.e, pain scale rating was "0").
Utilizing the standardized Wong-Baker visual analog pain scale, graded from 0 to 10 (no pain to increasingly worse pain (worst at 10/10))
Outcome measures
| Measure |
Group A
n=8 Participants
Intracanalicular dexamethasone insert is placed on day of crosslinking (CXL); patients will still receive postoperative fluoroquinolone (or other class in case of allergy) antibiotic eye drops with instructions for use (i.e. 1 drop in operative eye QID x 10 days).
Dextenza: Placement of intracanalicular dexamethasone insert for post-crosslinking inflammation and pain
|
Group B
n=10 Participants
Patients are placed on standard postoperative regimen of postoperative fluoroquinolone (or other class in case of allergy) antibiotic eye drops with instructions for use (i.e. 1 drop in operative eye QID x 10 days) and Prednisolone acetate 1% ophthalmic solution tapered over 1 month in the following schedule: QID x1 week, TID x 1 week, BID x 1 week, and Qday x 1 week.
Prednisolone Acetate: post-crosslinking eye drop prednisolone acetate given in a tapering schedule over 1 month
|
|---|---|---|
|
Change in Degree of Postoperative Pain Between Groups From Date of Surgery Through 1 Month Post-CXL (Day of Surgery, Postoperative Days 1 ,3, 7, Postoperative Weeks 2 ,3 and 4)
Postoperative day 0
|
6.4 score on a scale from 0 - 10
Standard Deviation 1.3
|
6.6 score on a scale from 0 - 10
Standard Deviation 1.62
|
|
Change in Degree of Postoperative Pain Between Groups From Date of Surgery Through 1 Month Post-CXL (Day of Surgery, Postoperative Days 1 ,3, 7, Postoperative Weeks 2 ,3 and 4)
Postoperative day 1
|
1.3 score on a scale from 0 - 10
Standard Deviation 0.45
|
2 score on a scale from 0 - 10
Standard Deviation 1.18
|
|
Change in Degree of Postoperative Pain Between Groups From Date of Surgery Through 1 Month Post-CXL (Day of Surgery, Postoperative Days 1 ,3, 7, Postoperative Weeks 2 ,3 and 4)
Postoperative day 3
|
0.2 score on a scale from 0 - 10
Standard Deviation 0.4
|
0 score on a scale from 0 - 10
Standard Deviation 0
|
|
Change in Degree of Postoperative Pain Between Groups From Date of Surgery Through 1 Month Post-CXL (Day of Surgery, Postoperative Days 1 ,3, 7, Postoperative Weeks 2 ,3 and 4)
Postoperative day 7
|
0 score on a scale from 0 - 10
Standard Deviation 0
|
0 score on a scale from 0 - 10
Standard Deviation 0
|
|
Change in Degree of Postoperative Pain Between Groups From Date of Surgery Through 1 Month Post-CXL (Day of Surgery, Postoperative Days 1 ,3, 7, Postoperative Weeks 2 ,3 and 4)
Postoperative week 2
|
0 score on a scale from 0 - 10
Standard Deviation 0
|
0 score on a scale from 0 - 10
Standard Deviation 0
|
|
Change in Degree of Postoperative Pain Between Groups From Date of Surgery Through 1 Month Post-CXL (Day of Surgery, Postoperative Days 1 ,3, 7, Postoperative Weeks 2 ,3 and 4)
Postoperative week 3
|
0 score on a scale from 0 - 10
Standard Deviation 0
|
0 score on a scale from 0 - 10
Standard Deviation 0
|
|
Change in Degree of Postoperative Pain Between Groups From Date of Surgery Through 1 Month Post-CXL (Day of Surgery, Postoperative Days 1 ,3, 7, Postoperative Weeks 2 ,3 and 4)
Postoperative week 4
|
0 score on a scale from 0 - 10
Standard Deviation 0
|
0 score on a scale from 0 - 10
Standard Deviation 0
|
PRIMARY outcome
Timeframe: assessed at day of surgery, postoperative days 1 ,3, 7, postoperative weeks 2 ,3 and 4 (7 visits total)Assessment of corneal edema/cells (if any), degree of conjunctiva injection (if any) Grading will be from 0 to 4, with "0" being no conjunctival injection, and "4" indicating severe, diffuse conjunctival injection. Presence of corneal cells will be noted if present or absent.
Outcome measures
| Measure |
Group A
n=8 Participants
Intracanalicular dexamethasone insert is placed on day of crosslinking (CXL); patients will still receive postoperative fluoroquinolone (or other class in case of allergy) antibiotic eye drops with instructions for use (i.e. 1 drop in operative eye QID x 10 days).
Dextenza: Placement of intracanalicular dexamethasone insert for post-crosslinking inflammation and pain
|
Group B
n=10 Participants
Patients are placed on standard postoperative regimen of postoperative fluoroquinolone (or other class in case of allergy) antibiotic eye drops with instructions for use (i.e. 1 drop in operative eye QID x 10 days) and Prednisolone acetate 1% ophthalmic solution tapered over 1 month in the following schedule: QID x1 week, TID x 1 week, BID x 1 week, and Qday x 1 week.
Prednisolone Acetate: post-crosslinking eye drop prednisolone acetate given in a tapering schedule over 1 month
|
|---|---|---|
|
Degree and Improvement of Ocular Surface Inflammation Between Groups From Date of Surgery Through 1 Month Post-CXL (Day of Surgery, Postoperative Days 1 ,3, 7, Postoperative Weeks 2 ,3 and 4)
date of surgery
|
0.5 score on a scale 0-4
Standard Deviation 0
|
0.5 score on a scale 0-4
Standard Deviation 0
|
|
Degree and Improvement of Ocular Surface Inflammation Between Groups From Date of Surgery Through 1 Month Post-CXL (Day of Surgery, Postoperative Days 1 ,3, 7, Postoperative Weeks 2 ,3 and 4)
postoperative day 1
|
0.5 score on a scale 0-4
Standard Deviation 0
|
0.5 score on a scale 0-4
Standard Deviation 0
|
|
Degree and Improvement of Ocular Surface Inflammation Between Groups From Date of Surgery Through 1 Month Post-CXL (Day of Surgery, Postoperative Days 1 ,3, 7, Postoperative Weeks 2 ,3 and 4)
postoperative day 3
|
0 score on a scale 0-4
Standard Deviation 0
|
0 score on a scale 0-4
Standard Deviation 0
|
|
Degree and Improvement of Ocular Surface Inflammation Between Groups From Date of Surgery Through 1 Month Post-CXL (Day of Surgery, Postoperative Days 1 ,3, 7, Postoperative Weeks 2 ,3 and 4)
postoperative day 7
|
0 score on a scale 0-4
Standard Deviation 0
|
0 score on a scale 0-4
Standard Deviation 0
|
|
Degree and Improvement of Ocular Surface Inflammation Between Groups From Date of Surgery Through 1 Month Post-CXL (Day of Surgery, Postoperative Days 1 ,3, 7, Postoperative Weeks 2 ,3 and 4)
postoperative week 2
|
0 score on a scale 0-4
Standard Deviation 0
|
0 score on a scale 0-4
Standard Deviation 0
|
|
Degree and Improvement of Ocular Surface Inflammation Between Groups From Date of Surgery Through 1 Month Post-CXL (Day of Surgery, Postoperative Days 1 ,3, 7, Postoperative Weeks 2 ,3 and 4)
postoperative week 3
|
0 score on a scale 0-4
Standard Deviation 0
|
0 score on a scale 0-4
Standard Deviation 0
|
|
Degree and Improvement of Ocular Surface Inflammation Between Groups From Date of Surgery Through 1 Month Post-CXL (Day of Surgery, Postoperative Days 1 ,3, 7, Postoperative Weeks 2 ,3 and 4)
postoperative week 4
|
0 score on a scale 0-4
Standard Deviation 0
|
0 score on a scale 0-4
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Assessed at 1 day of surgery, postoperative days 1 ,3, 7, postoperative weeks 2 ,3 and 4 (7 visits total)Evaluation of rate of corneal re-epithelialization post-crosslinking at 1 day of surgery, postoperative days 1 ,3, 7, postoperative weeks 2 ,3 and 4
Outcome measures
| Measure |
Group A
n=8 Participants
Intracanalicular dexamethasone insert is placed on day of crosslinking (CXL); patients will still receive postoperative fluoroquinolone (or other class in case of allergy) antibiotic eye drops with instructions for use (i.e. 1 drop in operative eye QID x 10 days).
Dextenza: Placement of intracanalicular dexamethasone insert for post-crosslinking inflammation and pain
|
Group B
n=10 Participants
Patients are placed on standard postoperative regimen of postoperative fluoroquinolone (or other class in case of allergy) antibiotic eye drops with instructions for use (i.e. 1 drop in operative eye QID x 10 days) and Prednisolone acetate 1% ophthalmic solution tapered over 1 month in the following schedule: QID x1 week, TID x 1 week, BID x 1 week, and Qday x 1 week.
Prednisolone Acetate: post-crosslinking eye drop prednisolone acetate given in a tapering schedule over 1 month
|
|---|---|---|
|
Rate of Corneal Re-epithelialization
Day of surgery
|
100 percentage epithelial defect
Standard Deviation 0
|
100 percentage epithelial defect
Standard Deviation 0
|
|
Rate of Corneal Re-epithelialization
Postoperative day 1
|
37.75 percentage epithelial defect
Standard Deviation 5.35
|
34.75 percentage epithelial defect
Standard Deviation 7.15
|
|
Rate of Corneal Re-epithelialization
Postoperative day 3
|
7.85 percentage epithelial defect
Standard Deviation 2.47
|
6 percentage epithelial defect
Standard Deviation 2
|
|
Rate of Corneal Re-epithelialization
Postoperative day 7
|
0 percentage epithelial defect
Standard Deviation 0
|
0 percentage epithelial defect
Standard Deviation 0
|
|
Rate of Corneal Re-epithelialization
postoperative week 2
|
0 percentage epithelial defect
Standard Deviation 0
|
0 percentage epithelial defect
Standard Deviation 0
|
|
Rate of Corneal Re-epithelialization
Postoperative week 3
|
0 percentage epithelial defect
Standard Deviation 0
|
0 percentage epithelial defect
Standard Deviation 0
|
|
Rate of Corneal Re-epithelialization
Postoperative week 4
|
0 percentage epithelial defect
Standard Deviation 0
|
0 percentage epithelial defect
Standard Deviation 0
|
SECONDARY outcome
Timeframe: postoperative week 4 (POW4)Population: Patients completed an ease-of-use questionnaire regarding postoperative eye drops.
Questionnaire at final visit regarding ease of postoperative eye drop use
Outcome measures
| Measure |
Group A
n=8 Participants
Intracanalicular dexamethasone insert is placed on day of crosslinking (CXL); patients will still receive postoperative fluoroquinolone (or other class in case of allergy) antibiotic eye drops with instructions for use (i.e. 1 drop in operative eye QID x 10 days).
Dextenza: Placement of intracanalicular dexamethasone insert for post-crosslinking inflammation and pain
|
Group B
n=10 Participants
Patients are placed on standard postoperative regimen of postoperative fluoroquinolone (or other class in case of allergy) antibiotic eye drops with instructions for use (i.e. 1 drop in operative eye QID x 10 days) and Prednisolone acetate 1% ophthalmic solution tapered over 1 month in the following schedule: QID x1 week, TID x 1 week, BID x 1 week, and Qday x 1 week.
Prednisolone Acetate: post-crosslinking eye drop prednisolone acetate given in a tapering schedule over 1 month
|
|---|---|---|
|
Subjective 'Ease of Postoperative Care' for Patients Receiving Standard Topical Steroid Eye Drop Taper vs. Dexamethasone Insert
Q2. "Was it cumbersome to use eyedrops for more than 10 days?" · "yes" to Question
|
0 Participants
|
0 Participants
|
|
Subjective 'Ease of Postoperative Care' for Patients Receiving Standard Topical Steroid Eye Drop Taper vs. Dexamethasone Insert
Q2. "Was it cumbersome to use eyedrops for more than 10 days?" · "no" to Question
|
8 Participants
|
10 Participants
|
|
Subjective 'Ease of Postoperative Care' for Patients Receiving Standard Topical Steroid Eye Drop Taper vs. Dexamethasone Insert
Q3. "Was it difficult to remember to use postoperative eye drops?" · "yes" to Question
|
0 Participants
|
0 Participants
|
|
Subjective 'Ease of Postoperative Care' for Patients Receiving Standard Topical Steroid Eye Drop Taper vs. Dexamethasone Insert
Q3. "Was it difficult to remember to use postoperative eye drops?" · "no" to Question
|
8 Participants
|
10 Participants
|
|
Subjective 'Ease of Postoperative Care' for Patients Receiving Standard Topical Steroid Eye Drop Taper vs. Dexamethasone Insert
Q1. "Were directions regarding eyedrop use post-CXL easy to follow? · "yes" to Question
|
8 Participants
|
10 Participants
|
|
Subjective 'Ease of Postoperative Care' for Patients Receiving Standard Topical Steroid Eye Drop Taper vs. Dexamethasone Insert
Q1. "Were directions regarding eyedrop use post-CXL easy to follow? · "no" to Question
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Assessement of use of additional/adjunctive pain/antiinflammatory medications will be done for each patient at postoperative days 1 ,3, 7, postoperative weeks 2 ,3 and 4 (7 visits total)Population: Number of patients using "rescue" pain medication were assessed from operative day (POD0) through POW4.
Use of oral non-steroidal anti-inflammatory (NSAID), acetaminophen, prescribed pain medication) between groups
Outcome measures
| Measure |
Group A
n=8 Participants
Intracanalicular dexamethasone insert is placed on day of crosslinking (CXL); patients will still receive postoperative fluoroquinolone (or other class in case of allergy) antibiotic eye drops with instructions for use (i.e. 1 drop in operative eye QID x 10 days).
Dextenza: Placement of intracanalicular dexamethasone insert for post-crosslinking inflammation and pain
|
Group B
n=10 Participants
Patients are placed on standard postoperative regimen of postoperative fluoroquinolone (or other class in case of allergy) antibiotic eye drops with instructions for use (i.e. 1 drop in operative eye QID x 10 days) and Prednisolone acetate 1% ophthalmic solution tapered over 1 month in the following schedule: QID x1 week, TID x 1 week, BID x 1 week, and Qday x 1 week.
Prednisolone Acetate: post-crosslinking eye drop prednisolone acetate given in a tapering schedule over 1 month
|
|---|---|---|
|
Notation of Need for Use of "Rescue" Pain Medication
POD 0 use of pain medication
|
6 Participants
|
6 Participants
|
|
Notation of Need for Use of "Rescue" Pain Medication
POD 1 use of pain medication
|
1 Participants
|
1 Participants
|
|
Notation of Need for Use of "Rescue" Pain Medication
POD 3 use of pain medication
|
0 Participants
|
0 Participants
|
|
Notation of Need for Use of "Rescue" Pain Medication
POD 7 use of pain medication
|
0 Participants
|
0 Participants
|
|
Notation of Need for Use of "Rescue" Pain Medication
POW2 use of pain medication
|
0 Participants
|
0 Participants
|
|
Notation of Need for Use of "Rescue" Pain Medication
POW3 use of pain medication
|
0 Participants
|
0 Participants
|
|
Notation of Need for Use of "Rescue" Pain Medication
POW4 use of pain medication
|
0 Participants
|
0 Participants
|
Adverse Events
Group A
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group B
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place