Trial Outcomes & Findings for A Clinical Trial to Evaluate the Corneal Endothelial Health of DED Subjects Treated With Cyclosporine (NCT NCT06329661)
NCT ID: NCT06329661
Last Updated: 2026-08-19
Results Overview
Change from baseline at 12 months in ECD measured as count/mm2 using specular microscopy in the study eye
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
204 participants
Primary outcome timeframe
12 months
Results posted on
2026-08-19
Participant Flow
Unit of analysis: study eye
Participant milestones
| Measure |
Cyclosporine Ophthalmic Solution, 0.1% (VEVYE)
Cyclosporine ophthalmic solution, 0.1%; 12 months
|
Saline Solution, 0.6%
Saline solution, 0.6%; 12 months
|
|---|---|---|
|
Overall Study
STARTED
|
135 135
|
69 69
|
|
Overall Study
COMPLETED
|
122 122
|
61 61
|
|
Overall Study
NOT COMPLETED
|
13 13
|
8 8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Clinical Trial to Evaluate the Corneal Endothelial Health of DED Subjects Treated With Cyclosporine
Baseline characteristics by cohort
| Measure |
Cyclosporine Ophthalmic Solution, 0.1% (VEVYE)
n=135 Participants
Cyclosporine ophthalmic solution, 0.1%; 12 months
|
Saline Solution, 0.6%
n=69 Participants
Saline solution, 0.6%; 12 months
|
Total
n=204 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=298 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=400 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
74 Participants
n=298 Participants
|
43 Participants
n=102 Participants
|
117 Participants
n=400 Participants
|
|
Age, Categorical
>=65 years
|
61 Participants
n=298 Participants
|
26 Participants
n=102 Participants
|
87 Participants
n=400 Participants
|
|
Sex: Female, Male
Female
|
105 Participants
n=298 Participants
|
50 Participants
n=102 Participants
|
155 Participants
n=400 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=298 Participants
|
19 Participants
n=102 Participants
|
49 Participants
n=400 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=298 Participants
|
10 Participants
n=102 Participants
|
17 Participants
n=400 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
128 Participants
n=298 Participants
|
59 Participants
n=102 Participants
|
187 Participants
n=400 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=298 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=400 Participants
|
|
Region of Enrollment
United States
|
135 Participants
n=298 Participants
|
69 Participants
n=102 Participants
|
204 Participants
n=400 Participants
|
|
Corneal Endothelial Cell Density
|
2488.6 cell/mm²
STANDARD_DEVIATION 283.32 • n=298 Participants
|
2507.7 cell/mm²
STANDARD_DEVIATION 250.23 • n=102 Participants
|
2495.0 cell/mm²
STANDARD_DEVIATION 272.11 • n=400 Participants
|
PRIMARY outcome
Timeframe: 12 monthsChange from baseline at 12 months in ECD measured as count/mm2 using specular microscopy in the study eye
Outcome measures
| Measure |
Cyclosporine Ophthalmic Solution, 0.1% (VEVYE)
n=135 study eye
Cyclosporine ophthalmic solution, 0.1%; 12 months
|
Saline Solution, 0.6%
n=69 study eye
Saline solution, 0.6%; 12 months
|
|---|---|---|
|
Change From Baseline in Corneal Endothelial Cell Density (ECD)
|
6.4 cells/mm²
Standard Deviation 90.47
|
-1.0 cells/mm²
Standard Deviation 81.43
|
Adverse Events
Cyclosporine Ophthalmic Solution, 0.1% (VEVYE)
Serious events: 5 serious events
Other events: 27 other events
Deaths: 0 deaths
Saline Solution, 0.6%
Serious events: 2 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cyclosporine Ophthalmic Solution, 0.1% (VEVYE)
n=135 participants at risk
Cyclosporine ophthalmic solution, 0.1%; 12 months
|
Saline Solution, 0.6%
n=69 participants at risk
Saline solution, 0.6%; 12 months
|
|---|---|---|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/135 • 52 weeks
|
1.4%
1/69 • Number of events 1 • 52 weeks
|
|
Gastrointestinal disorders
Mild Acute Pancreatitis
|
0.74%
1/135 • Number of events 1 • 52 weeks
|
0.00%
0/69 • 52 weeks
|
|
Blood and lymphatic system disorders
Anemia
|
0.74%
1/135 • Number of events 1 • 52 weeks
|
0.00%
0/69 • 52 weeks
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.74%
1/135 • Number of events 1 • 52 weeks
|
0.00%
0/69 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain secondary to posterolateral lumbar fusion surgery
|
0.74%
1/135 • Number of events 1 • 52 weeks
|
0.00%
0/69 • 52 weeks
|
|
Cardiac disorders
Worsening of coronary artery disease
|
0.00%
0/135 • 52 weeks
|
1.4%
1/69 • Number of events 1 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Worsening Osteoarthritis
|
0.74%
1/135 • Number of events 1 • 52 weeks
|
0.00%
0/69 • 52 weeks
|
Other adverse events
| Measure |
Cyclosporine Ophthalmic Solution, 0.1% (VEVYE)
n=135 participants at risk
Cyclosporine ophthalmic solution, 0.1%; 12 months
|
Saline Solution, 0.6%
n=69 participants at risk
Saline solution, 0.6%; 12 months
|
|---|---|---|
|
Vascular disorders
Hypertension
|
5.2%
7/135 • 52 weeks
|
8.7%
6/69 • 52 weeks
|
|
General disorders
Application site irritation
|
14.8%
20/135 • 52 weeks
|
10.1%
7/69 • 52 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place