Clinical trial NCT02824913: Study of the Pharmacodynamic Activity of P-321 Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye Disease
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Dry Eye Disease
Lead sponsor: Parion Sciences
Sponsor class: INDUSTRY
First posted: 2016-07-07
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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).

Eligibility criteria: Inclusion Criteria:

1. Provide written informed consent
2. Male or female subjects aged 18 to 80 years
3. Have a history of predominantly tear-deficient dry eye of mild to moderate severity, supported by a previous clinical diagnosis
4. Have normal lid anatomy
5. Subjects must:

   1. 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:

1. Have undergone refractive eye surgery in either eye during the past 12 months
2. Have undergone uncomplicated cataract surgery in either eye during the past 3 months
3. Have undergone previous eyelid surgery in either eye (External blepharoplasty, not resulting in exposure or abnormal blinking is allowed)
4. Have undergone botulinum toxin (BotoxTh1 or equivalent) injection in the periocular area within 3 months prior to Visit 1
5. 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
6. Have punctal plugs, punctal occlusion, history of nasolacrimal duct obstruction or wear scleral lens.
7. Past or present exposure keratopathy, neurotrophic keratopathy, lagophthalmos, or trichiasis

Primary outcomes:
measure: Change in Total Tear Meniscus Volume Following the Administration of P-321 Ophthalmic Solution or Placebo
timeFrame: Pre-dose and up to six hours after dose
Secondary outcomes:
measure: Lower Tear Meniscus Height as Measured by the Keratograph 5M
timeFrame: Pre-dose and up to six hours after dose
measure: Comparison of Lower Tear Meniscus Height Measurements Between UHR-OCT and Keratograph 5M
timeFrame: Pre-dose and up to six hours after dose
measure: Adverse Events
timeFrame: 2 or 7 hours
Other outcomes:
Locations:
city: Plantation
country: United States
facility: Bascom Palmer Eye Institute, University of Miami Health System
state: Florida
Study officials:
affiliation: Parion Sciences
name: Jose Boyer
role: STUDY_DIRECTOR
References: