Study of the Safety and Tolerability of P 321 Ophthalmic Solution in Subjects With Dry Eye Disease

NCT02242032 | Completed Phase 1

• 1 other identifier: P-321-101
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the safety and tolerability of P-321 Ophthalmic Solution in subjects with mild to moderate dry eye disease.

Conditions

Dry Eye Disease

Keywords

dry eye disease

Outcome Measures

Primary Outcomes (11)

• Number of subjects with adverse events

  One primary objective of this trial is to assess the safety of P-321 Ophthalmic Solution versus placebo in subjects with moderate dry eye disease at 14 days (Cohorts 1-4) and 28 days (Cohort 4 only).

  Days 0, 1, 2, 8, 15, 22 and 28

• Changes from baseline in 14 days in visual acuity.

  Change from baseline at 14 days in visual acuity.

  Change from baseline at 14 days.

• Change from baseline at 28 days in visual acuity for Cohort 4 only.

  Change from baseline at 28 days in visual acuity for Cohort 4 only.

  Change from baseline at 28 days in visual acuity.

• Changes from baseline at 14 days in corneal staining.

  Changes from baseline at 14 days in corneal staining.

  Changes from baseline at 14 days.

• Changes from baseline at 28 days in corneal staining for cohort 4 only.

  Changes from baseline at 28 days in corneal staining for cohort 4 only.

  Changes from baseline at 28 days.

• Changes from baseline at 14 days in conjunctival staining.

  Changes from baseline at 14 days in conjunctival staining.

  Changes from baseline at 14 days

• Changes from baseline at 28 days in conjunctival staining for Cohort 4 only.

  Changes from baseline at 28 days in conjunctival staining for Cohort 4 only.

  Changes from baseline at 28 days

• Changes from baseline at 14 days in intraocular pressure.

  Changes from baseline at 14 days in intraocular pressure.

  Changes from baseline at 14 days.

• Changes from baseline at 28 days in intraocular pressure. for Cohort 4 only.

  Changes from baseline at 28 days in intraocular pressure. for Cohort 4 only.

  Changes from baseline at 28 days

• Changes from baseline at 14 days in ophthalmoscopy.

  Changes from baseline at 14 days in ophthalmoscopy.

  Changes from baseline at 14 days

• Changes from baseline at 28 days in ophthalmoscopy for Cohort 4 only.

  Changes from baseline at 28 days in ophthalmoscopy for Cohort 4 only.

  Changes from baseline at 28 days

Secondary Outcomes (6)

• Measure plasma P-321 concentrations

  Pre-dose 0.5, 1, 2, 4, and 6 hours post dosing on Days 1 and Day 15 and pre-dose on Day 8.

• Measure urine concentrations of P-321

  At multiple timepoints throughout the study

• Measure tear concentrations of P-321

  pre-dose 0.5, 1, 2, 4, and 6 hours post dosing on Day 1 and Day 15 and pre-dose on Day 8.

• Measure plasma P-321 concentrations in Cohort 4

  pre-dose on Day 8 and Day 22, and pre-dose, 0.5, 1, 2, 4, 6, 8, and 24 hours post-dose on Day 28

• Measure urine concentrations of P-321 in Cohort 4

  Day 28

Study Arms (2)

P-321

EXPERIMENTAL

P-321 Ophthalmic Solution

Drug: P-321 Ophthalmic Solution

P-321 Ophthalmic Solution Placebo

PLACEBO COMPARATOR

P-321 Ophthalmic Solution Placebo

Drug: P-321 Ophthalmic Solution placebo

Interventions

P-321 Ophthalmic Solution DRUG

Also known as: P-321

P-321

P-321 Ophthalmic Solution placebo DRUG

Placebo to match P-321 Ophthalmic Solution

Also known as: placebo

P-321 Ophthalmic Solution Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals of both genders and any race will be eligible for study participation if they:
• Provide written informed consent.
• Are 18 - 80 years of age.
• Corneal fluorescein staining score ≥2/15 on the NEI/Industry scale
• Conjunctival lissamine staining score of ≥ 2/18 on the NEI/Industry scale
• Schirmer \<10mm/5min
• Are willing and able to follow instructions and can be present for the required study visits for the duration of the study.
• Female patients of child bearing potential must have a negative urine pregnancy test at Screening and agree to use a medically acceptable form of birth control. Male subjects who are sexually active must be willing to use highly effective contraception (i.e., less than 1% failure rate) during heterosexual intercourse from Day 1 through completion of the study.
• Have a history of Dry Eye Disease in both eyes supported by a previous clinical diagnosis or have a self-reported history of subjective complaints for at least 4 months prior to Screening, low tear volume, and ocular staining.
• Have documented history of topical lubricants at least daily or the desire to use topical lubricants in the past 4 months.
• Have normal lid anatomy

You may not qualify if:

• Individuals are not eligible for study participation if:
• Have anterior segment eye disease except primary dry eye.
• Patients with an identifiable or suspected secondary dry eye, i.e., a documented or likely systemic, ocular, pharmacologic, post-traumatic, post-surgical, or external cause for dry eye symptoms or ocular surface staining.
• Patients with current punctal plugs, punctal occlusion, or history of nasolacrimal duct obstruction are excluded.
• Have a history of glaucoma or intraocular pressure (IOP) \> 25 mmHg at the Screening Visit (Visit 1) or a history of elevated IOP within the past year prior to Visit 1
• Contact lenses wear in the previous 30 days or during the Treatment Phase of the study.
• Use of lid scrubs (including baby shampoos)
• Known hypersensitivity to the study investigational medicinal product, or formulation excipients, including amiloride or related drugs or allergies to the components of the study drug.
• Any significant chronic illness that, in the opinion of the Principal Investigator (PI), could interfere with the study parameters.
• Use of any investigational product or device within 30 days prior to the Screening Visit or during the study.
• Those unable in the opinion of the PI to comply fully with the study requirements or complete the study.

Sponsors & Collaborators

• Parion Sciences: lead

Study Sites (1)

Sall Research Medical Center

Artesia, California, 90701, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Kenneth Sall, MD

  Sall Research Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2014
• First Posted: September 16, 2014
• Study Start: July 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: May 4, 2015

Record last verified: 2015-05

Locations

US (1)