Status:
COMPLETED
Study of the Safety and Tolerability of P 321 Ophthalmic Solution in Subjects With Dry Eye Disease
Lead Sponsor:
Parion Sciences
Conditions:
Dry Eye Disease
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
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.
Detailed Description
This is a single-center, dose escalation, randomized, double-masked, placebo-controlled, Phase 1/2a trial designed to evaluate the safety and tolerability of P-321 Ophthalmic Solution in subjects with...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT02242032
Start Date
July 1 2014
End Date
March 1 2015
Last Update
May 4 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Sall Research Medical Center
Artesia, California, United States, 90701