A Phase 2 interventional study of P-321 Ophthalmic Solution and P-321 Ophthalmic Solution placebo in Dry Eye Disease, sponsored by Parion Sciences. Terminated at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-08-31.
Sponsored by Parion Sciences · Phase 2, Interventional, and Treatment
The purpose of this Phase 2a study is to assess changes in tear volume by the non-invasive techniques Ultra High Resolution Optical Coherence Tomography (UHR-OCT) following the administration of P-321 Ophthalmic Solution or Placebo in subjects with tear deficient dry eye disease.
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).
1,292 studies on the registry are indexed under Dry Eye Syndromes; 191 are open to participants now.
This study's enrollment of 1 is below the median of 60 across 1,077 interventional studies indexed under Dry Eye Syndromes.
Browse Dry Eye Syndromes studies →Parion Sciences is the lead sponsor of 9 studies on the registry; none are open to participants now.
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Subjects must:
Exclusion Criteria:
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
Placebo treatment administered to approximately 8 patients in Phase I and approximately 16 patients in Phase II
Drug: P-321 Ophthalmic Solution placebo
Also known as: P-321
Also known as: Placebo Comparator, Placebo
Change in Total Tear Meniscus Volume Following the Administration of P-321 Ophthalmic Solution or Placebo
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
Lower Tear Meniscus Height as Measured by the Keratograph 5M
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
Comparison of Lower Tear Meniscus Height Measurements Between UHR-OCT and Keratograph 5M
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
Adverse Events
Number of patients experiencing adverse events comparing P-321 to placebo
Time frame: 2 or 7 hours
| Milestone | P-321 Ophthalmic Solution Then Placebo Comparator | Placebo Comparator Then P-321 Ophthalmic Solution |
|---|---|---|
| Started | 1 | 0 |
| Completed | 1 | 0 |
| Not completed | 0 | 0 |
| Milestone | P-321 Ophthalmic Solution Then Placebo Comparator | Placebo Comparator Then P-321 Ophthalmic Solution |
|---|---|---|
| Started | 1 | 0 |
| Completed | 1 | 0 |
| Not completed | 0 | 0 |
| Milestone | P-321 Ophthalmic Solution Then Placebo Comparator | Placebo Comparator Then P-321 Ophthalmic Solution |
|---|---|---|
| Started | 1 | 0 |
| Completed | 1 | 0 |
| Not completed | 0 | 0 |
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.
No measurements were reported for this outcome.
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
No measurements were reported for this outcome.
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
No measurements were reported for this outcome.
Number of patients experiencing adverse events comparing P-321 to placebo
| Participants | P-321 Ophthalmic Solution Then Placebo Comparator | Placebo Comparator Then P-321 Ophthalmic Solution |
|---|---|---|
| Adverse Events | 0 | 0 |
Collected over 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).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| P-321 Ophthalmic Solution | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) |
| Drug: P-321 Ophthalmic Solution Placebo | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) |
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(Participants) | P-321 Ophthalmic Solution Then Placebo Comparator | Placebo Comparator Then P-321 Ophthalmic Solution | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 1 | 0 | 1 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | P-321 Ophthalmic Solution Then Placebo Comparator | Placebo Comparator Then P-321 Ophthalmic Solution | Total |
|---|---|---|---|
| Female | 1 | 0 | 1 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | P-321 Ophthalmic Solution Then Placebo Comparator | Placebo Comparator Then P-321 Ophthalmic Solution | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 0 | 1 |
| Not Hispanic or Latino | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | P-321 Ophthalmic Solution Then Placebo Comparator | Placebo Comparator Then P-321 Ophthalmic Solution | Total |
|---|---|---|---|
| United States | 1 | — | 1 |
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Parion Sciences