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

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ClinicalTrials.gov Identifier: NCT02242032
Recruitment Status : Completed
First Posted : September 16, 2014
Last Update Posted : May 4, 2015
Sponsor:
Information provided by (Responsible Party):
Parion Sciences

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.

Condition or disease Intervention/treatment Phase
Dry Eye Disease Drug: P-321 Ophthalmic Solution Drug: P-321 Ophthalmic Solution placebo Phase 1

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 mild to moderate dry eye for up to 4-weeks of treatment and up to 8 scheduled in clinic visits. This study will conduct a consecutive dose escalation of the following concentrations of P-321 Ophthalmic Solution given two times a day via ocular instillation: 0.0005% (Cohort 1), 0.0015% (Cohort 2), 0.005% (Cohort 3), and 0.01% (Cohort 4). Up to 48 subjects will be enrolled in four consecutive cohorts. Subjects will be randomized to P-321 Ophthalmic Solution or placebo in a 3:1 ratio.

Safety and tolerability assessments, drug plasma concentrations and drug urine concentrations will be evaluated throughout the study in all cohorts.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Masked, Randomized, Placebo-Controlled Dose Escalation Study of the Safety and Tolerability of P 321 Ophthalmic Solution in Subjects With Dry Eye Disease
Study Start Date : July 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Diseases

Arm Intervention/treatment
Experimental: P-321
P-321 Ophthalmic Solution
Drug: P-321 Ophthalmic Solution
Other Name: P-321

Placebo Comparator: P-321 Ophthalmic Solution Placebo
P-321 Ophthalmic Solution Placebo
Drug: P-321 Ophthalmic Solution placebo
Placebo to match P-321 Ophthalmic Solution
Other Name: placebo




Primary Outcome Measures :
  1. Number of subjects with adverse events [ Time Frame: Days 0, 1, 2, 8, 15, 22 and 28 ]
    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).

  2. Changes from baseline in 14 days in visual acuity. [ Time Frame: Change from baseline at 14 days. ]
    Change from baseline at 14 days in visual acuity.

  3. Change from baseline at 28 days in visual acuity for Cohort 4 only. [ Time Frame: Change from baseline at 28 days in visual acuity. ]
    Change from baseline at 28 days in visual acuity for Cohort 4 only.

  4. Changes from baseline at 14 days in corneal staining. [ Time Frame: Changes from baseline at 14 days. ]
    Changes from baseline at 14 days in corneal staining.

  5. Changes from baseline at 28 days in corneal staining for cohort 4 only. [ Time Frame: Changes from baseline at 28 days. ]
    Changes from baseline at 28 days in corneal staining for cohort 4 only.

  6. Changes from baseline at 14 days in conjunctival staining. [ Time Frame: Changes from baseline at 14 days ]
    Changes from baseline at 14 days in conjunctival staining.

  7. Changes from baseline at 28 days in conjunctival staining for Cohort 4 only. [ Time Frame: Changes from baseline at 28 days ]
    Changes from baseline at 28 days in conjunctival staining for Cohort 4 only.

  8. Changes from baseline at 14 days in intraocular pressure. [ Time Frame: Changes from baseline at 14 days. ]
    Changes from baseline at 14 days in intraocular pressure.

  9. Changes from baseline at 28 days in intraocular pressure. for Cohort 4 only. [ Time Frame: Changes from baseline at 28 days ]
    Changes from baseline at 28 days in intraocular pressure. for Cohort 4 only.

  10. Changes from baseline at 14 days in ophthalmoscopy. [ Time Frame: Changes from baseline at 14 days ]
    Changes from baseline at 14 days in ophthalmoscopy.

  11. Changes from baseline at 28 days in ophthalmoscopy for Cohort 4 only. [ Time Frame: Changes from baseline at 28 days ]
    Changes from baseline at 28 days in ophthalmoscopy for Cohort 4 only.


Secondary Outcome Measures :
  1. Measure plasma P-321 concentrations [ Time Frame: Pre-dose 0.5, 1, 2, 4, and 6 hours post dosing on Days 1 and Day 15 and pre-dose on Day 8. ]
    Drug plasma concentrations will be evaluated pre-dose 0.5, 1, 2, 4, and 6 hours post dosing on Days 1 and 15 and pre-dose on Day 8.

  2. Measure urine concentrations of P-321 [ Time Frame: At multiple timepoints throughout the study ]
    Drug urine concentrations will be evaluated at Day 1 and Day 15.

  3. Measure tear concentrations of P-321 [ Time Frame: pre-dose 0.5, 1, 2, 4, and 6 hours post dosing on Day 1 and Day 15 and pre-dose on Day 8. ]
    Drug tear concentrations will be evaluated at all visits post dose.

  4. Measure plasma P-321 concentrations in Cohort 4 [ Time Frame: 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 plasma P-321 concentrations in Cohort 4

  5. Measure urine concentrations of P-321 in Cohort 4 [ Time Frame: Day 28 ]
    Measure urine concentrations of P-321 in Cohort 4

  6. Measure tear concentrations of P-321 in Cohort 4 [ Time Frame: 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 tear concentrations of P-321 in Cohort 4



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Individuals of both genders and any race will be eligible for study participation if they:

    1. Provide written informed consent.
    2. Are 18 - 80 years of age.
    3. Corneal fluorescein staining score ≥2/15 on the NEI/Industry scale
    4. Conjunctival lissamine staining score of ≥ 2/18 on the NEI/Industry scale
    5. Schirmer <10mm/5min
    6. Are willing and able to follow instructions and can be present for the required study visits for the duration of the study.
    7. 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.
    8. 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.
    9. Have documented history of topical lubricants at least daily or the desire to use topical lubricants in the past 4 months.
    10. Have normal lid anatomy

Exclusion Criteria:

  • Individuals are not eligible for study participation if:

    1. Have anterior segment eye disease except primary dry eye.
    2. 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.
    3. Patients with current punctal plugs, punctal occlusion, or history of nasolacrimal duct obstruction are excluded.
    4. 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
    5. Contact lenses wear in the previous 30 days or during the Treatment Phase of the study.
    6. Use of lid scrubs (including baby shampoos)
    7. 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.
    8. Any significant chronic illness that, in the opinion of the Principal Investigator (PI), could interfere with the study parameters.
    9. Use of any investigational product or device within 30 days prior to the Screening Visit or during the study.
    10. Those unable in the opinion of the PI to comply fully with the study requirements or complete the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02242032


Locations
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United States, California
Sall Research Medical Center
Artesia, California, United States, 90701
Sponsors and Collaborators
Parion Sciences
Investigators
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Principal Investigator: Kenneth Sall, MD Sall Research Medical Center

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Responsible Party: Parion Sciences
ClinicalTrials.gov Identifier: NCT02242032     History of Changes
Other Study ID Numbers: P-321-101
First Posted: September 16, 2014    Key Record Dates
Last Update Posted: May 4, 2015
Last Verified: May 2015
Keywords provided by Parion Sciences:
dry eye disease
Additional relevant MeSH terms:
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Keratoconjunctivitis Sicca
Dry Eye Syndromes
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Ophthalmic Solutions
Pharmaceutical Solutions