Trial Outcomes & Findings for Study of Two Formulations of Cyclosporine Ophthalmic Emulsion in Healthy Volunteers and in Patients With Dry Eye (NCT NCT01319773)
NCT ID: NCT01319773
Last Updated: 2015-09-07
Results Overview
Concentration of cyclosporine measured in blood at Day 1 of the parallel-group phase (PGP). Blood samples were collected up to 3 hours post-dose and concentrations of cyclosporine were measured.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
44 participants
Primary outcome timeframe
Day 1
Results posted on
2015-09-07
Participant Flow
This study included a parallel-group phase (PGP) and a paired-eye phase (PEP). The paired-eye phase of the study began after the parallel-group phase completed. The parallel-group phase enrolled healthy volunteers and the paired-eye phase enrolled patients with dry eye symptoms.
Participant milestones
| Measure |
PGP: Cyclosporine Formulation A
Parallel-Group Phase (PGP): cyclosporine ophthalmic emulsion Formulation A
|
PGP: Cyclosporine Formulation B
PGP: cyclosporine ophthalmic emulsion Formulation B
|
PEP: Cyclosporine Formulation A and Cyclosporine 0.05%
Paired-Eye Phase (PEP): cyclosporine ophthalmic emulsion Formulation A and cyclosporine ophthalmic emulsion 0.05%
|
PEP: Cyclosporine Formulation B and Cyclosporine 0.05%
PEP: cyclosporine ophthalmic emulsion Formulation B and cyclosporine ophthalmic emulsion 0.05%
|
PEP: Cyclosporine Formulation A and Cyclosporine Formulation B
PEP: cyclosporine ophthalmic emulsion Formulation A and cyclosporine ophthalmic emulsion Formulation B
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
8
|
8
|
8
|
|
Overall Study
COMPLETED
|
10
|
10
|
8
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Two Formulations of Cyclosporine Ophthalmic Emulsion in Healthy Volunteers and in Patients With Dry Eye
Baseline characteristics by cohort
| Measure |
PGP: Cyclosporine Formulation A
n=10 Participants
Parallel-Group Phase (PGP): cyclosporine ophthalmic emulsion Formulation A
|
PGP: Cyclosporine Formulation B
n=10 Participants
PGP: cyclosporine ophthalmic emulsion Formulation B
|
PEP: Cyclosporine Formulation A and Cyclosporine 0.05%
n=8 Participants
Paired-Eye Phase (PEP): cyclosporine ophthalmic emulsion Formulation A and cyclosporine ophthalmic emulsion 0.05%
|
PEP: Cyclosporine Formulation B and Cyclosporine 0.05%
n=8 Participants
PEP: cyclosporine ophthalmic emulsion Formulation B and cyclosporine ophthalmic emulsion 0.05%
|
PEP: Cyclosporine Formulation A and Cyclosporine Formulation B
n=8 Participants
PEP: cyclosporine ophthalmic emulsion Formulation A and cyclosporine ophthalmic emulsion Formulation B
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Customized
18 to 30 years
|
8 participants
n=5 Participants
|
8 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
1 participants
n=21 Participants
|
19 participants
n=10 Participants
|
|
Age, Customized
> 30 to 40 years
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
0 participants
n=21 Participants
|
5 participants
n=10 Participants
|
|
Age, Customized
> 40 years
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
7 participants
n=5 Participants
|
6 participants
n=4 Participants
|
7 participants
n=21 Participants
|
20 participants
n=10 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
26 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
18 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Day 1Population: Safety Population: All randomized subjects who were treated with at least 1 dose of study medication.
Concentration of cyclosporine measured in blood at Day 1 of the parallel-group phase (PGP). Blood samples were collected up to 3 hours post-dose and concentrations of cyclosporine were measured.
Outcome measures
| Measure |
Cyclosporine Formulation A
n=10 Participants
|
Cyclosporine Formulation B
n=10 Participants
|
Cyclosporine 0.05%
|
|---|---|---|---|
|
Concentration of Cyclosporine Measured in Blood at Day 1 in the Parallel-Group Phase (PGP)
Time = pre-dose
|
NA Nanogram/milliliter (ng/mL)
Below limit of quantification
|
NA Nanogram/milliliter (ng/mL)
Below limit of quantification
|
—
|
|
Concentration of Cyclosporine Measured in Blood at Day 1 in the Parallel-Group Phase (PGP)
Time = 3 hours
|
NA Nanogram/milliliter (ng/mL)
Below limit of quantification
|
NA Nanogram/milliliter (ng/mL)
Below limit of quantification
|
—
|
|
Concentration of Cyclosporine Measured in Blood at Day 1 in the Parallel-Group Phase (PGP)
Time = 0.5 hours
|
NA Nanogram/milliliter (ng/mL)
Below limit of quantification
|
NA Nanogram/milliliter (ng/mL)
Below limit of quantification
|
—
|
|
Concentration of Cyclosporine Measured in Blood at Day 1 in the Parallel-Group Phase (PGP)
Time = 1 hour
|
NA Nanogram/milliliter (ng/mL)
Below limit of quantification
|
NA Nanogram/milliliter (ng/mL)
Below limit of quantification
|
—
|
SECONDARY outcome
Timeframe: 3 DaysPopulation: Per Protocol: All randomized subjects who received their assigned study medication and closely followed the protocol.
Number of subjects who reported ocular symptoms of any severity during the parallel-group phase (PGP) of the study. Subjects evaluated the presence and severity of ocular symptoms in each eye. The severity of each symptom (blurring, foreign body sensation, pain, burning/stinging, tearing, and itching) were recorded on a 5-point scale (0=none, +0.5=very mild,+1=mild, +2=moderate, and +3=severe).
Outcome measures
| Measure |
Cyclosporine Formulation A
n=10 Participants
|
Cyclosporine Formulation B
n=10 Participants
|
Cyclosporine 0.05%
|
|---|---|---|---|
|
Number of Subjects Who Reported Ocular Symptoms During the Parallel-Group Phase (PGP)
|
3 Number of Subjects
|
1 Number of Subjects
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: Per Protocol: All randomized subjects who received their assigned study medication and closely followed the protocol.
Number of eyes with ocular symptoms of any severity, post-dose in the paired-eye phase (PEP) at Day 1. Subjects evaluated the presence and severity of ocular symptoms in each eye. The severity of each symptom (blurring, foreign body sensation, pain, burning/stinging, tearing, and itching) were recorded on a 5-point scale (0=none, +0.5=very mild, +1=mild, +2=moderate, and +3=severe).
Outcome measures
| Measure |
Cyclosporine Formulation A
n=16 Eyes
|
Cyclosporine Formulation B
n=16 Eyes
|
Cyclosporine 0.05%
n=16 Eyes
|
|---|---|---|---|
|
Number of Eyes With Ocular Symptoms Post-Dose During the Paired-Eye Phase (PEP) at Day 1
Tearing
|
1 Number of Eyes
|
2 Number of Eyes
|
3 Number of Eyes
|
|
Number of Eyes With Ocular Symptoms Post-Dose During the Paired-Eye Phase (PEP) at Day 1
Itching
|
0 Number of Eyes
|
0 Number of Eyes
|
0 Number of Eyes
|
|
Number of Eyes With Ocular Symptoms Post-Dose During the Paired-Eye Phase (PEP) at Day 1
Blurring
|
2 Number of Eyes
|
1 Number of Eyes
|
1 Number of Eyes
|
|
Number of Eyes With Ocular Symptoms Post-Dose During the Paired-Eye Phase (PEP) at Day 1
Foreign Body Sensation
|
0 Number of Eyes
|
0 Number of Eyes
|
0 Number of Eyes
|
|
Number of Eyes With Ocular Symptoms Post-Dose During the Paired-Eye Phase (PEP) at Day 1
Pain
|
0 Number of Eyes
|
1 Number of Eyes
|
0 Number of Eyes
|
|
Number of Eyes With Ocular Symptoms Post-Dose During the Paired-Eye Phase (PEP) at Day 1
Burning/Stinging
|
3 Number of Eyes
|
2 Number of Eyes
|
2 Number of Eyes
|
Adverse Events
PGP: Cyclosporine Formulation A
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
PGP: Cyclosporine Formulation B
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
PEP: Cyclosporine Formulation A and Cyclosporine 0.05%
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
PEP: Cyclosporine Formulation B and Cyclosporine 0.05%
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
PEP: Cyclosporine Formulation A and Cyclosporine Formulation B
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
PGP: Cyclosporine Formulation A
n=10 participants at risk
Parallel-Group Phase (PGP): cyclosporine ophthalmic emulsion Formulation A
|
PGP: Cyclosporine Formulation B
n=10 participants at risk
PGP: cyclosporine ophthalmic emulsion Formulation B
|
PEP: Cyclosporine Formulation A and Cyclosporine 0.05%
n=8 participants at risk
Paired-Eye Phase (PEP): cyclosporine ophthalmic emulsion Formulation A and cyclosporine ophthalmic emulsion 0.05%
|
PEP: Cyclosporine Formulation B and Cyclosporine 0.05%
n=8 participants at risk
PEP: cyclosporine ophthalmic emulsion Formulation B and cyclosporine ophthalmic emulsion 0.05%
|
PEP: Cyclosporine Formulation A and Cyclosporine Formulation B
n=8 participants at risk
PEP: cyclosporine ophthalmic emulsion Formulation A and cyclosporine ophthalmic emulsion Formulation B
|
|---|---|---|---|---|---|
|
Nervous system disorders
Headache
|
20.0%
2/10
SAEs and AEs are reported by treatment assignment or arm as randomized not by individual intervention received.
|
0.00%
0/10
SAEs and AEs are reported by treatment assignment or arm as randomized not by individual intervention received.
|
0.00%
0/8
SAEs and AEs are reported by treatment assignment or arm as randomized not by individual intervention received.
|
0.00%
0/8
SAEs and AEs are reported by treatment assignment or arm as randomized not by individual intervention received.
|
0.00%
0/8
SAEs and AEs are reported by treatment assignment or arm as randomized not by individual intervention received.
|
|
Eye disorders
Punctate Keratitis
|
10.0%
1/10
SAEs and AEs are reported by treatment assignment or arm as randomized not by individual intervention received.
|
20.0%
2/10
SAEs and AEs are reported by treatment assignment or arm as randomized not by individual intervention received.
|
25.0%
2/8
SAEs and AEs are reported by treatment assignment or arm as randomized not by individual intervention received.
|
12.5%
1/8
SAEs and AEs are reported by treatment assignment or arm as randomized not by individual intervention received.
|
0.00%
0/8
SAEs and AEs are reported by treatment assignment or arm as randomized not by individual intervention received.
|
|
Eye disorders
Conjunctival Hyperaemia
|
10.0%
1/10
SAEs and AEs are reported by treatment assignment or arm as randomized not by individual intervention received.
|
0.00%
0/10
SAEs and AEs are reported by treatment assignment or arm as randomized not by individual intervention received.
|
50.0%
4/8
SAEs and AEs are reported by treatment assignment or arm as randomized not by individual intervention received.
|
50.0%
4/8
SAEs and AEs are reported by treatment assignment or arm as randomized not by individual intervention received.
|
75.0%
6/8
SAEs and AEs are reported by treatment assignment or arm as randomized not by individual intervention received.
|
|
Eye disorders
Abnormal Sensation in Eye
|
0.00%
0/10
SAEs and AEs are reported by treatment assignment or arm as randomized not by individual intervention received.
|
0.00%
0/10
SAEs and AEs are reported by treatment assignment or arm as randomized not by individual intervention received.
|
12.5%
1/8
SAEs and AEs are reported by treatment assignment or arm as randomized not by individual intervention received.
|
0.00%
0/8
SAEs and AEs are reported by treatment assignment or arm as randomized not by individual intervention received.
|
12.5%
1/8
SAEs and AEs are reported by treatment assignment or arm as randomized not by individual intervention received.
|
|
Eye disorders
Dry Eye
|
0.00%
0/10
SAEs and AEs are reported by treatment assignment or arm as randomized not by individual intervention received.
|
0.00%
0/10
SAEs and AEs are reported by treatment assignment or arm as randomized not by individual intervention received.
|
12.5%
1/8
SAEs and AEs are reported by treatment assignment or arm as randomized not by individual intervention received.
|
0.00%
0/8
SAEs and AEs are reported by treatment assignment or arm as randomized not by individual intervention received.
|
0.00%
0/8
SAEs and AEs are reported by treatment assignment or arm as randomized not by individual intervention received.
|
|
Eye disorders
Eyelid Irritation
|
0.00%
0/10
SAEs and AEs are reported by treatment assignment or arm as randomized not by individual intervention received.
|
0.00%
0/10
SAEs and AEs are reported by treatment assignment or arm as randomized not by individual intervention received.
|
12.5%
1/8
SAEs and AEs are reported by treatment assignment or arm as randomized not by individual intervention received.
|
0.00%
0/8
SAEs and AEs are reported by treatment assignment or arm as randomized not by individual intervention received.
|
0.00%
0/8
SAEs and AEs are reported by treatment assignment or arm as randomized not by individual intervention received.
|
|
Eye disorders
Eye Irritation
|
0.00%
0/10
SAEs and AEs are reported by treatment assignment or arm as randomized not by individual intervention received.
|
0.00%
0/10
SAEs and AEs are reported by treatment assignment or arm as randomized not by individual intervention received.
|
0.00%
0/8
SAEs and AEs are reported by treatment assignment or arm as randomized not by individual intervention received.
|
62.5%
5/8
SAEs and AEs are reported by treatment assignment or arm as randomized not by individual intervention received.
|
25.0%
2/8
SAEs and AEs are reported by treatment assignment or arm as randomized not by individual intervention received.
|
|
Eye disorders
Eye Pain
|
0.00%
0/10
SAEs and AEs are reported by treatment assignment or arm as randomized not by individual intervention received.
|
0.00%
0/10
SAEs and AEs are reported by treatment assignment or arm as randomized not by individual intervention received.
|
0.00%
0/8
SAEs and AEs are reported by treatment assignment or arm as randomized not by individual intervention received.
|
37.5%
3/8
SAEs and AEs are reported by treatment assignment or arm as randomized not by individual intervention received.
|
12.5%
1/8
SAEs and AEs are reported by treatment assignment or arm as randomized not by individual intervention received.
|
|
Eye disorders
Eye Pruritus
|
0.00%
0/10
SAEs and AEs are reported by treatment assignment or arm as randomized not by individual intervention received.
|
0.00%
0/10
SAEs and AEs are reported by treatment assignment or arm as randomized not by individual intervention received.
|
0.00%
0/8
SAEs and AEs are reported by treatment assignment or arm as randomized not by individual intervention received.
|
25.0%
2/8
SAEs and AEs are reported by treatment assignment or arm as randomized not by individual intervention received.
|
37.5%
3/8
SAEs and AEs are reported by treatment assignment or arm as randomized not by individual intervention received.
|
|
Eye disorders
Lacrimation Increased
|
0.00%
0/10
SAEs and AEs are reported by treatment assignment or arm as randomized not by individual intervention received.
|
0.00%
0/10
SAEs and AEs are reported by treatment assignment or arm as randomized not by individual intervention received.
|
0.00%
0/8
SAEs and AEs are reported by treatment assignment or arm as randomized not by individual intervention received.
|
25.0%
2/8
SAEs and AEs are reported by treatment assignment or arm as randomized not by individual intervention received.
|
12.5%
1/8
SAEs and AEs are reported by treatment assignment or arm as randomized not by individual intervention received.
|
|
Eye disorders
Vision Blurred
|
0.00%
0/10
SAEs and AEs are reported by treatment assignment or arm as randomized not by individual intervention received.
|
0.00%
0/10
SAEs and AEs are reported by treatment assignment or arm as randomized not by individual intervention received.
|
0.00%
0/8
SAEs and AEs are reported by treatment assignment or arm as randomized not by individual intervention received.
|
12.5%
1/8
SAEs and AEs are reported by treatment assignment or arm as randomized not by individual intervention received.
|
25.0%
2/8
SAEs and AEs are reported by treatment assignment or arm as randomized not by individual intervention received.
|
|
Eye disorders
Eye Discharge
|
0.00%
0/10
SAEs and AEs are reported by treatment assignment or arm as randomized not by individual intervention received.
|
0.00%
0/10
SAEs and AEs are reported by treatment assignment or arm as randomized not by individual intervention received.
|
0.00%
0/8
SAEs and AEs are reported by treatment assignment or arm as randomized not by individual intervention received.
|
12.5%
1/8
SAEs and AEs are reported by treatment assignment or arm as randomized not by individual intervention received.
|
12.5%
1/8
SAEs and AEs are reported by treatment assignment or arm as randomized not by individual intervention received.
|
|
Nervous system disorders
Dysguesia
|
0.00%
0/10
SAEs and AEs are reported by treatment assignment or arm as randomized not by individual intervention received.
|
0.00%
0/10
SAEs and AEs are reported by treatment assignment or arm as randomized not by individual intervention received.
|
0.00%
0/8
SAEs and AEs are reported by treatment assignment or arm as randomized not by individual intervention received.
|
12.5%
1/8
SAEs and AEs are reported by treatment assignment or arm as randomized not by individual intervention received.
|
0.00%
0/8
SAEs and AEs are reported by treatment assignment or arm as randomized not by individual intervention received.
|
|
Eye disorders
Foreign Body Sensation in Eyes
|
0.00%
0/10
SAEs and AEs are reported by treatment assignment or arm as randomized not by individual intervention received.
|
0.00%
0/10
SAEs and AEs are reported by treatment assignment or arm as randomized not by individual intervention received.
|
0.00%
0/8
SAEs and AEs are reported by treatment assignment or arm as randomized not by individual intervention received.
|
0.00%
0/8
SAEs and AEs are reported by treatment assignment or arm as randomized not by individual intervention received.
|
12.5%
1/8
SAEs and AEs are reported by treatment assignment or arm as randomized not by individual intervention received.
|
|
Eye disorders
Photophobia
|
0.00%
0/10
SAEs and AEs are reported by treatment assignment or arm as randomized not by individual intervention received.
|
0.00%
0/10
SAEs and AEs are reported by treatment assignment or arm as randomized not by individual intervention received.
|
0.00%
0/8
SAEs and AEs are reported by treatment assignment or arm as randomized not by individual intervention received.
|
0.00%
0/8
SAEs and AEs are reported by treatment assignment or arm as randomized not by individual intervention received.
|
12.5%
1/8
SAEs and AEs are reported by treatment assignment or arm as randomized not by individual intervention received.
|
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