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Trial record 4 of 10 for:    parion

Study of the Pharmacodynamic Activity of P-321 Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02824913
Recruitment Status : Terminated
First Posted : July 7, 2016
Results First Posted : January 19, 2018
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
Parion Sciences

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Dry Eye Disease
Interventions Drug: P-321 Ophthalmic Solution
Drug: P-321 Ophthalmic Solution placebo
Enrollment 1
Recruitment Details  
Pre-assignment Details  
Arm/Group Title P-321 Ophthalmic Solution Then Placebo Comparator Placebo Comparator Then P-321 Ophthalmic Solution
Hide Arm/Group Description

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

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

Period Title: First Intervention (1 Day)
Started 1 0
Completed 1 [1] 0
Not Completed 0 0
[1]
Only one subject was enrolled in the study and received both study treatments.
Period Title: Washout (7-14 Days)
Started 1 0
Completed 1 0
Not Completed 0 0
Period Title: Second Intervention (1 Day)
Started 1 0
Completed 1 0
Not Completed 0 0
Arm/Group Title P-321 Ophthalmic Solution Then Placebo Comparator Placebo Comparator Then P-321 Ophthalmic Solution Total
Hide Arm/Group Description

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

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 of all reporting groups
Overall Number of Baseline Participants 1 0 1
Hide Baseline Analysis Population Description
Only one patient was enrolled in the study, the patient was randomized into the Group of P-321 Ophthalmic Solution Then Placebo Comparator. No patients participated in the Group of Placebo Comparator Then P-321 Ophthalmic Solution
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 0 participants 1 participants
<=18 years
0
   0.0%
0
0
   0.0%
Between 18 and 65 years
1
 100.0%
0
1
 100.0%
>=65 years
0
   0.0%
0
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 0 participants 1 participants
Female 1 0 1
Male 0 0 0
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 0 participants 1 participants
Hispanic or Latino
1
 100.0%
0
1
 100.0%
Not Hispanic or Latino
0
   0.0%
0
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 1 participants 0 participants 1 participants
1 1
1.Primary Outcome
Title Change in Total Tear Meniscus Volume Following the Administration of P-321 Ophthalmic Solution or Placebo
Hide Description 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.
Time Frame Pre-dose and up to six hours after dose
Hide Outcome Measure Data
Hide Analysis Population Description

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.

Arm/Group Title P-321 Ophthalmic Solution Then Placebo Comparator Placebo Comparator Then P-321 Ophthalmic Solution
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Lower Tear Meniscus Height as Measured by the Keratograph 5M
Hide Description 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
Time Frame Pre-dose and up to six hours after dose
Hide Outcome Measure Data
Hide Analysis Population Description

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.

Arm/Group Title P-321 Ophthalmic Solution Then Placebo Comparator Placebo Comparator Then P-321 Ophthalmic Solution
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Comparison of Lower Tear Meniscus Height Measurements Between UHR-OCT and Keratograph 5M
Hide Description 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
Time Frame Pre-dose and up to six hours after dose
Hide Outcome Measure Data
Hide Analysis Population Description

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.

Arm/Group Title P-321 Ophthalmic Solution Then Placebo Comparator Placebo Comparator Then P-321 Ophthalmic Solution
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Adverse Events
Hide Description Number of patients experiencing adverse events comparing P-321 to placebo
Time Frame 2 or 7 hours
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title P-321 Ophthalmic Solution Then Placebo Comparator Placebo Comparator Then P-321 Ophthalmic Solution
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 1 0
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
Time Frame Subjects were to receive 2 treatments (P-321 Ophthalmic Solution and Placebo) during this study; first treatment on Visit 2 (3 to 9 days after screening) and second treatment on Visit 3 (7 to 14 days after the first treatment).
Adverse Event Reporting Description An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which did not necessarily have to have a causal relationship with this treatment. A treatment-emergent AE (TEAE) was an AE that either commenced following initiation of study treatment or was present prior to study treatment but increased in frequency or severity following initiation of study treatment.
 
Arm/Group Title P-321 Ophthalmic Solution Drug: P-321 Ophthalmic Solution Placebo
Hide Arm/Group Description

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

Placebo treatment administered to approximately 8 patients in Phase I and approximately 16 patients in Phase II

P-321 Ophthalmic Solution placebo

All-Cause Mortality
P-321 Ophthalmic Solution Drug: P-321 Ophthalmic Solution Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   0/1 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
P-321 Ophthalmic Solution Drug: P-321 Ophthalmic Solution Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   0/1 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
P-321 Ophthalmic Solution Drug: P-321 Ophthalmic Solution Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   0/1 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jose Boyer
Organization: Parion Sciences
Phone: 919-313-1182
EMail: jboyer@parion.com
Layout table for additonal information
Responsible Party: Parion Sciences
ClinicalTrials.gov Identifier: NCT02824913     History of Changes
Other Study ID Numbers: P-321-201
First Submitted: July 1, 2016
First Posted: July 7, 2016
Results First Submitted: December 22, 2017
Results First Posted: January 19, 2018
Last Update Posted: August 31, 2018