Study of the Pharmacodynamic Activity of P-321 Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye Disease
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|ClinicalTrials.gov Identifier: NCT02824913|
Recruitment Status : Terminated
First Posted : July 7, 2016
Results First Posted : January 19, 2018
Last Update Posted : August 31, 2018
|Condition or disease||Intervention/treatment||Phase|
|Dry Eye Disease||Drug: P-321 Ophthalmic Solution Drug: P-321 Ophthalmic Solution placebo||Phase 2|
This is a single-center, randomized, cross-over placebo controlled study to evaluate the changes in tear volume by P-321 Ophthalmic Solution and Placebo. The study will enroll subjects with tear deficient dry eye disease to receive sequentially one of two treatment sequences: P-321 Ophthalmic Solution then Placebo or Placebo then P-321. The study will consist of two Phases: In each Phase, subjects will be treated with P-321 Ophthalmic Solution under the same study design.
Approximately twenty-four eligible subjects will complete the study with approximately 8 subjects participating in Phase 1 and the remainder of the 24 subjects participating in the phase 2. Decisions on the dose to be used in Phase 2 will be made based on Phase 1 data.
The study will consist of three study visits: a Screening Visit (Visit 1), and two treatment visits (Visit 2 and Visit 3). The primary and secondary outcome measures will be assessed at each treatment visit. Safety assessments include adverse events (AEs).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Randomized, Crossover Study of the Pharmacodynamic Activity of P-321 Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye Disease Characterized by Low Tear Volume|
|Actual Study Start Date :||July 2016|
|Actual Primary Completion Date :||March 2017|
|Actual Study Completion Date :||March 2017|
Experimental: P-321 Ophthalmic Solution
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
Drug: P-321 Ophthalmic Solution
Other Name: P-321
Placebo Comparator: Drug: P-321 Ophthalmic Solution placebo
Placebo treatment administered to approximately 8 patients in Phase I and approximately 16 patients in Phase II
Drug: P-321 Ophthalmic Solution placebo
- Change in Total Tear Meniscus Volume Following the Administration of P-321 Ophthalmic Solution or Placebo [ Time Frame: Pre-dose and up to six hours after dose ]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.
- Lower Tear Meniscus Height as Measured by the Keratograph 5M [ Time Frame: Pre-dose and up to six hours after dose ]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
- Comparison of Lower Tear Meniscus Height Measurements Between UHR-OCT and Keratograph 5M [ Time Frame: Pre-dose and up to six hours after dose ]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
- Adverse Events [ Time Frame: 2 or 7 hours ]Number of patients experiencing adverse events comparing P-321 to placebo
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02824913
|United States, Florida|
|Bascom Palmer Eye Institute, University of Miami Health System|
|Plantation, Florida, United States, 33324|
|Study Director:||Jose Boyer||Parion Sciences|