Trial Outcomes & Findings for Phase 2 Study of a New Ophthalmic Formulation of Cyclosporine (Restasis® X) in Patients With Dry Eye Disease (NCT NCT02013791)
NCT ID: NCT02013791
Last Updated: 2018-05-15
Results Overview
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. TEAEs are AEs with an onset that occurs after receiving study drug.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
55 participants
Primary outcome timeframe
First dose of study drug to up to 24 Weeks
Results posted on
2018-05-15
Participant Flow
This study was terminated. Stage 2 of the study was not conducted.
Participant milestones
| Measure |
Stage 1 Cohort 5A
Cyclosporine New Ophthalmic Formulation Dose D administered to the study eye and vehicle administered to the non-study eye on Day 1.
|
Stage 1 Cohort 4
Cyclosporine New Ophthalmic Formulation Dose C administered to study eye and Vehicle administered to non-study eye on Day 1.
|
Stage 1 Cohort 6C
Cyclosporine New Ophthalmic Formulation Dose C administered to study eye and Vehicle administered to non-study eye on Day 1 and retreatment at Week 12 if applicable.
|
Stage 1 Cohort 3
Cyclosporine New Ophthalmic Formulation Dose B administered to study eye and Vehicle administered to non-study eye on Day 1.
|
Stage 1 Cohort 2
Cyclosporine New Ophthalmic Formulation Dose A administered to study eye and Vehicle administered to non-study eye on Day 1.
|
Stage 1 Cohort 6B
Cyclosporine New Ophthalmic Formulation Dose F administered to study eye and Vehicle administered to non-study eye on Day 1.
|
Stage 1 Cohort 6D
Cyclosporine New Ophthalmic Formulation Dose F administered to study eye and Vehicle administered to non-study eye on Day 1 and retreatment at Week 12 if applicable.
|
Stage 1 Cohort 6A
Cyclosporine New Ophthalmic Formulation Dose E administered to study eye and Vehicle administered to non-study eye on Day 1.
|
Stage 1 Cohort 1
Vehicle administered to study eye and Sham administered to non-study eye on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
Period 1
STARTED
|
8
|
8
|
4
|
8
|
4
|
8
|
4
|
8
|
3
|
|
Period 1
COMPLETED
|
8
|
6
|
4
|
7
|
4
|
8
|
3
|
7
|
3
|
|
Period 1
NOT COMPLETED
|
0
|
2
|
0
|
1
|
0
|
0
|
1
|
1
|
0
|
|
Period 2
STARTED
|
0
|
0
|
2
|
0
|
0
|
0
|
3
|
0
|
0
|
|
Period 2
COMPLETED
|
0
|
0
|
2
|
0
|
0
|
0
|
3
|
0
|
0
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Stage 1 Cohort 5A
Cyclosporine New Ophthalmic Formulation Dose D administered to the study eye and vehicle administered to the non-study eye on Day 1.
|
Stage 1 Cohort 4
Cyclosporine New Ophthalmic Formulation Dose C administered to study eye and Vehicle administered to non-study eye on Day 1.
|
Stage 1 Cohort 6C
Cyclosporine New Ophthalmic Formulation Dose C administered to study eye and Vehicle administered to non-study eye on Day 1 and retreatment at Week 12 if applicable.
|
Stage 1 Cohort 3
Cyclosporine New Ophthalmic Formulation Dose B administered to study eye and Vehicle administered to non-study eye on Day 1.
|
Stage 1 Cohort 2
Cyclosporine New Ophthalmic Formulation Dose A administered to study eye and Vehicle administered to non-study eye on Day 1.
|
Stage 1 Cohort 6B
Cyclosporine New Ophthalmic Formulation Dose F administered to study eye and Vehicle administered to non-study eye on Day 1.
|
Stage 1 Cohort 6D
Cyclosporine New Ophthalmic Formulation Dose F administered to study eye and Vehicle administered to non-study eye on Day 1 and retreatment at Week 12 if applicable.
|
Stage 1 Cohort 6A
Cyclosporine New Ophthalmic Formulation Dose E administered to study eye and Vehicle administered to non-study eye on Day 1.
|
Stage 1 Cohort 1
Vehicle administered to study eye and Sham administered to non-study eye on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
Period 1
Lost to Follow-up
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
1
|
0
|
|
Period 1
Other Miscellaneous Reasons
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Phase 2 Study of a New Ophthalmic Formulation of Cyclosporine (Restasis® X) in Patients With Dry Eye Disease
Baseline characteristics by cohort
| Measure |
Stage 1 Cohort 5A
n=8 Participants
Cyclosporine New Ophthalmic Formulation Dose D administered to the study eye and vehicle administered to the non-study eye on Day 1.
|
Stage 1 Cohort 4
n=8 Participants
Cyclosporine New Ophthalmic Formulation Dose C administered to study eye and Vehicle administered to non-study eye on Day 1.
|
Stage 1 Cohort 6C
n=4 Participants
Cyclosporine New Ophthalmic Formulation Dose C administered to study eye and Vehicle administered to non-study eye on Day 1 and retreatment at Week 12 if applicable.
|
Stage 1 Cohort 3
n=8 Participants
Cyclosporine New Ophthalmic Formulation Dose B administered to study eye and Vehicle administered to non-study eye on Day 1.
|
Stage 1 Cohort 2
n=4 Participants
Cyclosporine New Ophthalmic Formulation Dose A administered to study eye and Vehicle administered to non-study eye on Day 1.
|
Stage 1 Cohort 6B
n=8 Participants
Cyclosporine New Ophthalmic Formulation Dose F administered to study eye and Vehicle administered to non-study eye on Day 1.
|
Stage 1 Cohort 6D
n=4 Participants
Cyclosporine New Ophthalmic Formulation Dose F administered to study eye and Vehicle administered to non-study eye on Day 1 and retreatment at Week 12 if applicable.
|
Stage 1 Cohort 6A
n=8 Participants
Cyclosporine New Ophthalmic Formulation Dose E administered to study eye and Vehicle administered to non-study eye on Day 1.
|
Stage 1 Cohort 1
n=3 Participants
Vehicle administered to study eye and Sham administered to non-study eye on Day 1.
|
Total
n=55 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
52.8 years
STANDARD_DEVIATION 14.47 • n=5 Participants
|
55.3 years
STANDARD_DEVIATION 6.58 • n=7 Participants
|
58.5 years
STANDARD_DEVIATION 6.95 • n=5 Participants
|
50.1 years
STANDARD_DEVIATION 15.06 • n=4 Participants
|
52.3 years
STANDARD_DEVIATION 11.64 • n=21 Participants
|
57.4 years
STANDARD_DEVIATION 10.69 • n=8 Participants
|
52.8 years
STANDARD_DEVIATION 13.45 • n=8 Participants
|
53.1 years
STANDARD_DEVIATION 12.19 • n=24 Participants
|
56.0 years
STANDARD_DEVIATION 7.55 • n=42 Participants
|
54.0 years
STANDARD_DEVIATION 11.19 • n=42 Participants
|
|
Age, Customized
<45 years
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
10 Participants
n=42 Participants
|
|
Age, Customized
45 to 65 years
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
5 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
36 Participants
n=42 Participants
|
|
Age, Customized
>65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
9 Participants
n=42 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
7 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
40 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
15 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
White
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
10 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
7 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
33 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: First dose of study drug to up to 24 WeeksPopulation: Safety Population included all participants who received at least one dose of study drug.
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. TEAEs are AEs with an onset that occurs after receiving study drug.
Outcome measures
| Measure |
Stage 1 Cohort 5A
n=8 Participants
Cyclosporine New Ophthalmic Formulation Dose D administered to the study eye and vehicle administered to the non-study eye on Day 1.
|
Stage 1 Cohort 4
n=8 Participants
Cyclosporine New Ophthalmic Formulation Dose C administered to study eye and Vehicle administered to non-study eye on Day 1.
|
Stage 1 Cohort 6C
n=4 Participants
Cyclosporine New Ophthalmic Formulation Dose C administered to study eye and Vehicle administered to non-study eye on Day 1 and retreatment at Week 12 if applicable.
|
Stage 1 Cohort 3
n=8 Participants
Cyclosporine New Ophthalmic Formulation Dose B administered to study eye and Vehicle administered to non-study eye on Day 1.
|
Stage 1 Cohort 2
n=4 Participants
Cyclosporine New Ophthalmic Formulation Dose A administered to study eye and Vehicle administered to non-study eye on Day 1.
|
Stage 1 Cohort 6B
n=8 Participants
Cyclosporine New Ophthalmic Formulation Dose F administered to study eye and Vehicle administered to non-study eye on Day 1.
|
Stage 1 Cohort 6D
n=4 Participants
Cyclosporine New Ophthalmic Formulation Dose F administered to study eye and Vehicle administered to non-study eye on Day 1 and retreatment at Week 12 if applicable.
|
Stage 1 Cohort 6A
n=8 Participants
Cyclosporine New Ophthalmic Formulation Dose E administered to study eye and Vehicle administered to non-study eye on Day 1.
|
Stage 1 Cohort 1
n=3 Participants
Vehicle administered to study eye and Sham administered to non-study eye on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
|
7 Participants
|
8 Participants
|
4 Participants
|
6 Participants
|
4 Participants
|
7 Participants
|
3 Participants
|
5 Participants
|
3 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Day 1) to Week 12Population: Modified Intent-to-treat (mITT) Population included all participant who received study treatment and had Baseline and at least 1 post-baseline assessment. Analyses includes participants who had data at both Baseline and Week 12.
Total corneal staining with sodium fluorescein was measured in the study eye using the 6-point Oxford scale \[Grade 0: \<2 dots (best), Grade 1: ≥2 to ≤10 dots, Grade 2: \>10 to ≤32 dots, Grade 3: \>32 to ≤100 dots, Grade 4: \>100 to ≤316 dots and Grade 5: \>316 dots or ulcer/erosion (worst)\]. The study eye was defined as the eye that received the dosing level of the treatment received. A negative change from Baseline represents a decrease in staining (improvement). Corneal Staining Score was originally registered as a Primary endpoint but it is actually an exploratory endpoint.
Outcome measures
| Measure |
Stage 1 Cohort 5A
n=6 Participants
Cyclosporine New Ophthalmic Formulation Dose D administered to the study eye and vehicle administered to the non-study eye on Day 1.
|
Stage 1 Cohort 4
Cyclosporine New Ophthalmic Formulation Dose C administered to study eye and Vehicle administered to non-study eye on Day 1.
|
Stage 1 Cohort 6C
Cyclosporine New Ophthalmic Formulation Dose C administered to study eye and Vehicle administered to non-study eye on Day 1 and retreatment at Week 12 if applicable.
|
Stage 1 Cohort 3
Cyclosporine New Ophthalmic Formulation Dose B administered to study eye and Vehicle administered to non-study eye on Day 1.
|
Stage 1 Cohort 2
Cyclosporine New Ophthalmic Formulation Dose A administered to study eye and Vehicle administered to non-study eye on Day 1.
|
Stage 1 Cohort 6B
Cyclosporine New Ophthalmic Formulation Dose F administered to study eye and Vehicle administered to non-study eye on Day 1.
|
Stage 1 Cohort 6D
Cyclosporine New Ophthalmic Formulation Dose F administered to study eye and Vehicle administered to non-study eye on Day 1 and retreatment at Week 12 if applicable.
|
Stage 1 Cohort 6A
Cyclosporine New Ophthalmic Formulation Dose E administered to study eye and Vehicle administered to non-study eye on Day 1.
|
Stage 1 Cohort 1
Vehicle administered to study eye and Sham administered to non-study eye on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Corneal Staining Score Using a 6-Point Scale
Baseline
|
2.5 score on a scale
Standard Deviation 0.55
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Corneal Staining Score Using a 6-Point Scale
Change from Baseline to Week 12
|
-0.8 score on a scale
Standard Deviation 1.33
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Stage 1 Cohort 5A
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Stage 1 Cohort 4
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Stage 1 Cohort 6C
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Stage 1 Cohort 3
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Stage 1 Cohort 2
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Stage 1 Cohort 6B
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Stage 1 Cohort 6D
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Stage 1 Cohort 6A
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Stage 1 Cohort 1
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Stage 1 Cohort 5A
n=8 participants at risk
Cyclosporine New Ophthalmic Formulation Dose D administered to the study eye and vehicle administered to the non-study eye on Day 1.
|
Stage 1 Cohort 4
n=8 participants at risk
Cyclosporine New Ophthalmic Formulation Dose C administered to study eye and Vehicle administered to non-study eye on Day 1.
|
Stage 1 Cohort 6C
n=4 participants at risk
Cyclosporine New Ophthalmic Formulation Dose C administered to study eye and Vehicle administered to non-study eye on Day 1 and retreatment at Week 12 if applicable.
|
Stage 1 Cohort 3
n=8 participants at risk
Cyclosporine New Ophthalmic Formulation Dose B administered to study eye and Vehicle administered to non-study eye on Day 1.
|
Stage 1 Cohort 2
n=4 participants at risk
Cyclosporine New Ophthalmic Formulation Dose A administered to study eye and Vehicle administered to non-study eye on Day 1.
|
Stage 1 Cohort 6B
n=8 participants at risk
Cyclosporine New Ophthalmic Formulation Dose F administered to study eye and Vehicle administered to non-study eye on Day 1.
|
Stage 1 Cohort 6D
n=4 participants at risk
Cyclosporine New Ophthalmic Formulation Dose F administered to study eye and Vehicle administered to non-study eye on Day 1 and retreatment at Week 12 if applicable.
|
Stage 1 Cohort 6A
n=8 participants at risk
Cyclosporine New Ophthalmic Formulation Dose E administered to study eye and Vehicle administered to non-study eye on Day 1.
|
Stage 1 Cohort 1
n=3 participants at risk
Vehicle administered to study eye and Sham administered to non-study eye on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
12.5%
1/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/4 • First dose of study drug to up to 24 Weeks
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/4 • First dose of study drug to up to 24 Weeks
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/4 • First dose of study drug to up to 24 Weeks
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/3 • First dose of study drug to up to 24 Weeks
|
Other adverse events
| Measure |
Stage 1 Cohort 5A
n=8 participants at risk
Cyclosporine New Ophthalmic Formulation Dose D administered to the study eye and vehicle administered to the non-study eye on Day 1.
|
Stage 1 Cohort 4
n=8 participants at risk
Cyclosporine New Ophthalmic Formulation Dose C administered to study eye and Vehicle administered to non-study eye on Day 1.
|
Stage 1 Cohort 6C
n=4 participants at risk
Cyclosporine New Ophthalmic Formulation Dose C administered to study eye and Vehicle administered to non-study eye on Day 1 and retreatment at Week 12 if applicable.
|
Stage 1 Cohort 3
n=8 participants at risk
Cyclosporine New Ophthalmic Formulation Dose B administered to study eye and Vehicle administered to non-study eye on Day 1.
|
Stage 1 Cohort 2
n=4 participants at risk
Cyclosporine New Ophthalmic Formulation Dose A administered to study eye and Vehicle administered to non-study eye on Day 1.
|
Stage 1 Cohort 6B
n=8 participants at risk
Cyclosporine New Ophthalmic Formulation Dose F administered to study eye and Vehicle administered to non-study eye on Day 1.
|
Stage 1 Cohort 6D
n=4 participants at risk
Cyclosporine New Ophthalmic Formulation Dose F administered to study eye and Vehicle administered to non-study eye on Day 1 and retreatment at Week 12 if applicable.
|
Stage 1 Cohort 6A
n=8 participants at risk
Cyclosporine New Ophthalmic Formulation Dose E administered to study eye and Vehicle administered to non-study eye on Day 1.
|
Stage 1 Cohort 1
n=3 participants at risk
Vehicle administered to study eye and Sham administered to non-study eye on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
Eye disorders
Asthenopia
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/4 • First dose of study drug to up to 24 Weeks
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/4 • First dose of study drug to up to 24 Weeks
|
12.5%
1/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/4 • First dose of study drug to up to 24 Weeks
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/3 • First dose of study drug to up to 24 Weeks
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
12.5%
1/8 • First dose of study drug to up to 24 Weeks
|
25.0%
1/4 • First dose of study drug to up to 24 Weeks
|
12.5%
1/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/4 • First dose of study drug to up to 24 Weeks
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
50.0%
2/4 • First dose of study drug to up to 24 Weeks
|
12.5%
1/8 • First dose of study drug to up to 24 Weeks
|
33.3%
1/3 • First dose of study drug to up to 24 Weeks
|
|
Eye disorders
Conjunctival hyperaemia
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/4 • First dose of study drug to up to 24 Weeks
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/4 • First dose of study drug to up to 24 Weeks
|
12.5%
1/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/4 • First dose of study drug to up to 24 Weeks
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/3 • First dose of study drug to up to 24 Weeks
|
|
Eye disorders
Conjunctival oedema
|
12.5%
1/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
50.0%
2/4 • First dose of study drug to up to 24 Weeks
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/4 • First dose of study drug to up to 24 Weeks
|
12.5%
1/8 • First dose of study drug to up to 24 Weeks
|
50.0%
2/4 • First dose of study drug to up to 24 Weeks
|
12.5%
1/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/3 • First dose of study drug to up to 24 Weeks
|
|
Eye disorders
Corneal deposits
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/4 • First dose of study drug to up to 24 Weeks
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
25.0%
1/4 • First dose of study drug to up to 24 Weeks
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/4 • First dose of study drug to up to 24 Weeks
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/3 • First dose of study drug to up to 24 Weeks
|
|
Eye disorders
Dry eye
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/4 • First dose of study drug to up to 24 Weeks
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/4 • First dose of study drug to up to 24 Weeks
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/4 • First dose of study drug to up to 24 Weeks
|
12.5%
1/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/3 • First dose of study drug to up to 24 Weeks
|
|
Eye disorders
Eye discharge
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/4 • First dose of study drug to up to 24 Weeks
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/4 • First dose of study drug to up to 24 Weeks
|
12.5%
1/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/4 • First dose of study drug to up to 24 Weeks
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
33.3%
1/3 • First dose of study drug to up to 24 Weeks
|
|
Eye disorders
Eye irritation
|
12.5%
1/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/4 • First dose of study drug to up to 24 Weeks
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/4 • First dose of study drug to up to 24 Weeks
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/4 • First dose of study drug to up to 24 Weeks
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/3 • First dose of study drug to up to 24 Weeks
|
|
Eye disorders
Eye pain
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
25.0%
2/8 • First dose of study drug to up to 24 Weeks
|
25.0%
1/4 • First dose of study drug to up to 24 Weeks
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
25.0%
1/4 • First dose of study drug to up to 24 Weeks
|
12.5%
1/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/4 • First dose of study drug to up to 24 Weeks
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/3 • First dose of study drug to up to 24 Weeks
|
|
Eye disorders
Eyelids pruritus
|
12.5%
1/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/4 • First dose of study drug to up to 24 Weeks
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/4 • First dose of study drug to up to 24 Weeks
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/4 • First dose of study drug to up to 24 Weeks
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/3 • First dose of study drug to up to 24 Weeks
|
|
Eye disorders
Foreign body sensation in eyes
|
37.5%
3/8 • First dose of study drug to up to 24 Weeks
|
37.5%
3/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/4 • First dose of study drug to up to 24 Weeks
|
50.0%
4/8 • First dose of study drug to up to 24 Weeks
|
25.0%
1/4 • First dose of study drug to up to 24 Weeks
|
25.0%
2/8 • First dose of study drug to up to 24 Weeks
|
25.0%
1/4 • First dose of study drug to up to 24 Weeks
|
25.0%
2/8 • First dose of study drug to up to 24 Weeks
|
66.7%
2/3 • First dose of study drug to up to 24 Weeks
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
12.5%
1/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/4 • First dose of study drug to up to 24 Weeks
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/4 • First dose of study drug to up to 24 Weeks
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/4 • First dose of study drug to up to 24 Weeks
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/3 • First dose of study drug to up to 24 Weeks
|
|
Eye disorders
Meibomian gland discharge
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/4 • First dose of study drug to up to 24 Weeks
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/4 • First dose of study drug to up to 24 Weeks
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/4 • First dose of study drug to up to 24 Weeks
|
12.5%
1/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/3 • First dose of study drug to up to 24 Weeks
|
|
Eye disorders
Ocular discomfort
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
12.5%
1/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/4 • First dose of study drug to up to 24 Weeks
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/4 • First dose of study drug to up to 24 Weeks
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/4 • First dose of study drug to up to 24 Weeks
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/3 • First dose of study drug to up to 24 Weeks
|
|
Eye disorders
Punctate keratitis
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/4 • First dose of study drug to up to 24 Weeks
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/4 • First dose of study drug to up to 24 Weeks
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/4 • First dose of study drug to up to 24 Weeks
|
12.5%
1/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/3 • First dose of study drug to up to 24 Weeks
|
|
General disorders
Injection site erythema
|
50.0%
4/8 • First dose of study drug to up to 24 Weeks
|
62.5%
5/8 • First dose of study drug to up to 24 Weeks
|
100.0%
4/4 • First dose of study drug to up to 24 Weeks
|
25.0%
2/8 • First dose of study drug to up to 24 Weeks
|
75.0%
3/4 • First dose of study drug to up to 24 Weeks
|
75.0%
6/8 • First dose of study drug to up to 24 Weeks
|
50.0%
2/4 • First dose of study drug to up to 24 Weeks
|
25.0%
2/8 • First dose of study drug to up to 24 Weeks
|
33.3%
1/3 • First dose of study drug to up to 24 Weeks
|
|
General disorders
Injection site pain
|
12.5%
1/8 • First dose of study drug to up to 24 Weeks
|
12.5%
1/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/4 • First dose of study drug to up to 24 Weeks
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
25.0%
1/4 • First dose of study drug to up to 24 Weeks
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
25.0%
1/4 • First dose of study drug to up to 24 Weeks
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/3 • First dose of study drug to up to 24 Weeks
|
|
General disorders
Instillation site pain
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/4 • First dose of study drug to up to 24 Weeks
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/4 • First dose of study drug to up to 24 Weeks
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
25.0%
1/4 • First dose of study drug to up to 24 Weeks
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/3 • First dose of study drug to up to 24 Weeks
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
12.5%
1/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/4 • First dose of study drug to up to 24 Weeks
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/4 • First dose of study drug to up to 24 Weeks
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/4 • First dose of study drug to up to 24 Weeks
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/3 • First dose of study drug to up to 24 Weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
12.5%
1/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/4 • First dose of study drug to up to 24 Weeks
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/4 • First dose of study drug to up to 24 Weeks
|
12.5%
1/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/4 • First dose of study drug to up to 24 Weeks
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/3 • First dose of study drug to up to 24 Weeks
|
|
Injury, poisoning and procedural complications
Conjunctival abrasion
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/4 • First dose of study drug to up to 24 Weeks
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/4 • First dose of study drug to up to 24 Weeks
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/4 • First dose of study drug to up to 24 Weeks
|
12.5%
1/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/3 • First dose of study drug to up to 24 Weeks
|
|
Eye disorders
Vision blurred
|
12.5%
1/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/4 • First dose of study drug to up to 24 Weeks
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
25.0%
1/4 • First dose of study drug to up to 24 Weeks
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/4 • First dose of study drug to up to 24 Weeks
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/3 • First dose of study drug to up to 24 Weeks
|
|
Injury, poisoning and procedural complications
Foreign body in eye
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/4 • First dose of study drug to up to 24 Weeks
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
25.0%
1/4 • First dose of study drug to up to 24 Weeks
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/4 • First dose of study drug to up to 24 Weeks
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/3 • First dose of study drug to up to 24 Weeks
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/4 • First dose of study drug to up to 24 Weeks
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
25.0%
1/4 • First dose of study drug to up to 24 Weeks
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/4 • First dose of study drug to up to 24 Weeks
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/3 • First dose of study drug to up to 24 Weeks
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
12.5%
1/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/4 • First dose of study drug to up to 24 Weeks
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/4 • First dose of study drug to up to 24 Weeks
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/4 • First dose of study drug to up to 24 Weeks
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/3 • First dose of study drug to up to 24 Weeks
|
|
Investigations
Antinuclear antibody positive
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
50.0%
2/4 • First dose of study drug to up to 24 Weeks
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/4 • First dose of study drug to up to 24 Weeks
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/4 • First dose of study drug to up to 24 Weeks
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/3 • First dose of study drug to up to 24 Weeks
|
|
Investigations
Blood urine present
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/4 • First dose of study drug to up to 24 Weeks
|
12.5%
1/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/4 • First dose of study drug to up to 24 Weeks
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/4 • First dose of study drug to up to 24 Weeks
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/3 • First dose of study drug to up to 24 Weeks
|
|
Investigations
Red blood cell count increased
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/4 • First dose of study drug to up to 24 Weeks
|
12.5%
1/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/4 • First dose of study drug to up to 24 Weeks
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/4 • First dose of study drug to up to 24 Weeks
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/3 • First dose of study drug to up to 24 Weeks
|
|
Nervous system disorders
Headache
|
12.5%
1/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/4 • First dose of study drug to up to 24 Weeks
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
25.0%
1/4 • First dose of study drug to up to 24 Weeks
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/4 • First dose of study drug to up to 24 Weeks
|
0.00%
0/8 • First dose of study drug to up to 24 Weeks
|
0.00%
0/3 • First dose of study drug to up to 24 Weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER