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
Overview
- Phase
- Phase 2
- Intervention
- P-321 Ophthalmic Solution
- Conditions
- Dry Eye Disease
- Sponsor
- Parion Sciences
- Enrollment
- 1
- Locations
- 1
- Primary Endpoint
- Change in Total Tear Meniscus Volume Following the Administration of P-321 Ophthalmic Solution or Placebo
- Status
- Terminated
- Last Updated
- 7 years ago
Overview
Brief Summary
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.
Detailed Description
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).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Provide written informed consent
- •Male or female subjects aged 18 to 80 years
- •Have a history of predominantly tear-deficient dry eye of mild to moderate severity, supported by a previous clinical diagnosis
- •Have normal lid anatomy
- •Subjects must:
- •Remain on current medications for the duration of the study and have been on the current medication regimen at least during the past 28 days
Exclusion Criteria
- •Have undergone refractive eye surgery in either eye during the past 12 months
- •Have undergone uncomplicated cataract surgery in either eye during the past 3 months
- •Have undergone previous eyelid surgery in either eye (External blepharoplasty, not resulting in exposure or abnormal blinking is allowed)
- •Have undergone botulinum toxin (BotoxTh1 or equivalent) injection in the periocular area within 3 months prior to Visit 1
- •Subjects that have a systemic, multi-organ disease requiring active medical or surgical treatment are excluded with the exception of subjects with SS or GVHD
- •Have punctal plugs, punctal occlusion, history of nasolacrimal duct obstruction or wear scleral lens.
- •Past or present exposure keratopathy, neurotrophic keratopathy, lagophthalmos, or trichiasis
Arms & Interventions
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
Intervention: P-321 Ophthalmic Solution
Drug: P-321 Ophthalmic Solution placebo
Placebo treatment administered to approximately 8 patients in Phase I and approximately 16 patients in Phase II
Intervention: P-321 Ophthalmic Solution placebo
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Comparison of Lower Tear Meniscus Height Measurements Between UHR-OCT and Keratograph 5M(Pre-dose and up to six hours after dose)
- Adverse Events(2 or 7 hours)
- Lower Tear Meniscus Height as Measured by the Keratograph 5M(Pre-dose and up to six hours after dose)