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

Phase 2

Terminated

• Conditions: Dry Eye Disease
• Interventions: Drug: P-321 Ophthalmic Solution placebo; Drug: P-321 Ophthalmic Solution

• Registration Number: NCT02824913
• Lead Sponsor: Parion Sciences

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).

Study Timeline

• Study Start: 2016-07
• Study First Submitted: 2016-07-01
• Study First Submitted QC: 2016-07-01
• Study First Posted: 2016-07-07
• Primary Completion: 2017-03
• Study Completion: 2017-03
• Status Verified: 2017-12
• Results First Submitted: 2017-12-22
• Results First Submitted QC: 2017-12-22
• Results First Posted: 2018-01-19
• Last Update Submitted: 2018-08-03
• Last Update Posted: 2018-08-31

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Drug: P-321 Ophthalmic Solution placebo	P-321 Ophthalmic Solution placebo	Placebo treatment administered to approximately 8 patients in Phase I and approximately 16 patients in Phase II
P-321 Ophthalmic Solution	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

Primary Outcome Measures

Name	Time	Method
Change in Total Tear Meniscus Volume Following the Administration of P-321 Ophthalmic Solution or Placebo	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 Outcome Measures

Name	Time	Method
Comparison of Lower Tear Meniscus Height Measurements Between UHR-OCT and Keratograph 5M	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	2 or 7 hours	Number of patients experiencing adverse events comparing P-321 to placebo
Lower Tear Meniscus Height as Measured by the Keratograph 5M	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

Trial Locations

Locations (1)

Bascom Palmer Eye Institute, University of Miami Health System; 🇺🇸 Plantation, Florida, United States