Trial Outcomes & Findings for Study of the Pharmacodynamic Activity of P-321 Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye Disease (NCT NCT02824913)
NCT ID: NCT02824913
Last Updated: 2018-08-31
Results Overview
Tear meniscus volume, from measurements of tear meniscus area by UHR-OCT and the length of the eyelid was estimated over time (0 to 6 hours) following administration of placebo or P-321 Ophthalmic Solution.
TERMINATED
PHASE2
1 participants
Pre-dose and up to six hours after dose
2018-08-31
Participant Flow
Participant milestones
| Measure |
P-321 Ophthalmic Solution Then Placebo Comparator
At Visit 2 0.017% P-321 Ophthalmic Solution will be administered to approximately 8 patients in Phase I and either 0.05% P-321 Ophthalmic Solution or 0.01% P-321 Ophthalmic Solution or additional 0.017% P-321 Ophthalmic Solution will be administered to approximately 16 patients in Phase II
After a washout period of 7-14 days at Visit 3 Placebo Comparator will be administered to approximately 8 patients in Phase I and approximately 16 patients in Phase II
|
Placebo Comparator Then P-321 Ophthalmic Solution
At Visit 2 Placebo treatment will be administered to approximately 8 patients in Phase I and approximately 16 patients in Phase II
After a washout period of 7-14 days at Visit 3 0.017% P-321 Ophthalmic Solution will be administered to approximately 8 patients in Phase I and either 0.05% P-321 Ophthalmic Solution or 0.01% P-321 Ophthalmic Solution or additional 0.017% P-321 Ophthalmic Solution will be administered to approximately 16 patients in Phase II
|
|---|---|---|
|
First Intervention (1 Day)
STARTED
|
1
|
0
|
|
First Intervention (1 Day)
COMPLETED
|
1
|
0
|
|
First Intervention (1 Day)
NOT COMPLETED
|
0
|
0
|
|
Washout (7-14 Days)
STARTED
|
1
|
0
|
|
Washout (7-14 Days)
COMPLETED
|
1
|
0
|
|
Washout (7-14 Days)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (1 Day)
STARTED
|
1
|
0
|
|
Second Intervention (1 Day)
COMPLETED
|
1
|
0
|
|
Second Intervention (1 Day)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of the Pharmacodynamic Activity of P-321 Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye Disease
Baseline characteristics by cohort
| Measure |
P-321 Ophthalmic Solution Then Placebo Comparator
n=1 Participants
At Visit 2 0.017% P-321 Ophthalmic Solution will be administered to approximately 8 patients in Phase I and either 0.05% P-321 Ophthalmic Solution or 0.01% P-321 Ophthalmic Solution or additional 0.017% P-321 Ophthalmic Solution will be administered to approximately 16 patients in Phase II P-321 Ophthalmic Solution
At Visit 3 Placebo comparator will be administered to approximately 8 patients in Phase I and approximately 16 patients in Phase II
|
Placebo Comparator Then P-321 Ophthalmic Solution
At Visit 2 Placebo comparator will be administered to approximately 8 patients in Phase I and approximately 16 patients in Phase II
At Visit 3 0.017% P-321 Ophthalmic Solution will be administered to approximately 8 patients in Phase I and either 0.05% P-321 Ophthalmic Solution or 0.01% P-321 Ophthalmic Solution or additional 0.017% P-321 Ophthalmic Solution will be administered to approximately 16 patients in Phase II P-321 Ophthalmic Solution
|
Total
n=1 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
—
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Pre-dose and up to six hours after dosePopulation: One subject enrolled in the study. Subject received both study treatments (a single instillation of 0.017% P-321 Ophthalmic Solution in both eyes and a single instillation of Placebo in both eyes). Study was terminated, raw data obtained. Processing of data was not conducted to obtain primary and secondary outcomes, therefore none reported.
Tear meniscus volume, from measurements of tear meniscus area by UHR-OCT and the length of the eyelid was estimated over time (0 to 6 hours) following administration of placebo or P-321 Ophthalmic Solution.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose and up to six hours after dosePopulation: One subject enrolled in the study. Subject received both study treatments (a single instillation of 0.017% P-321 Ophthalmic Solution in both eyes and a single instillation of Placebo in both eyes). Study was terminated, raw data obtained. Processing of data was not conducted to obtain primary and secondary outcomes, therefore none reported.
Tear meniscus height of the inferior eyelid was measured with the Keratograph 5M over time (0 to 6 hours) following the administration of placebo or P-321 Ophthalmic Solution
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose and up to six hours after dosePopulation: One subject enrolled in the study. Subject received both study treatments (a single instillation of 0.017% P-321 Ophthalmic Solution in both eyes and a single instillation of Placebo in both eyes). Study was terminated, raw data obtained. Processing of data was not conducted to obtain primary and secondary outcomes, therefore none reported.
Tear meniscus height of the inferior eyelid was measured by UHR-OCT and Keratograph 5M over time (0 to 6 hours) following the administration of placebo or P-321 Ophthalmic Solution
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 or 7 hoursPopulation: One subject enrolled in the study. Subject received both study treatments (a single instillation of 0.017% P-321 Ophthalmic Solution in both eyes and a single instillation of Placebo in both eyes).
Number of patients experiencing adverse events comparing P-321 to placebo
Outcome measures
| Measure |
P-321 Ophthalmic Solution Then Placebo Comparator
n=1 Participants
At Visit 2 0.017% P-321 Ophthalmic Solution will be administered to approximately 8 patients in Phase I and either 0.05% P-321 Ophthalmic Solution or 0.01% P-321 Ophthalmic Solution or additional 0.017% P-321 Ophthalmic Solution will be administered to approximately 16 patients in Phase II P-321 Ophthalmic Solution
At Visit 3 Placebo comparator will be administered to approximately 8 patients in Phase I and approximately 16 patients in Phase II
|
Placebo Comparator Then P-321 Ophthalmic Solution
At Visit 2 Placebo comparator will be administered to approximately 8 patients in Phase I and approximately 16 patients in Phase II
At Visit 3 0.017% P-321 Ophthalmic Solution will be administered to approximately 8 patients in Phase I and either 0.05% P-321 Ophthalmic Solution or 0.01% P-321 Ophthalmic Solution or additional 0.017% P-321 Ophthalmic Solution will be administered to approximately 16 patients in Phase II P-321 Ophthalmic Solution
|
|---|---|---|
|
Adverse Events
|
0 Participants
|
0 Participants
|
Adverse Events
P-321 Ophthalmic Solution
Drug: P-321 Ophthalmic Solution Placebo
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 Principal Investigator may publish or present the results based on data generated at their Institution, provided that: (a) Sponsor publishes the results from all sites participating in the Study; (b) Institution receives notification from Sponsor that publication of the multi-site results is no longer planned; or (c) twelve (12) months following the close of study, whichever occurs first.
- Publication restrictions are in place
Restriction type: OTHER