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

Completed · Phase 1 · Has a placebo group

Conditions studied: Dry Eye Disease

In brief

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.

Key facts

Study ID

NCT02242032

Run by

Parion Sciences

People needed

53

Starts

2014-07-01

Expected to finish

2015-03-01

Last updated by the study team

2015-05-04

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Sall Research Medical Center — Artesia, California, United States

Full record on ClinicalTrials.gov

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