Evaluation of P-321 Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye Disease

NCT02831387 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: P-321-202
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 7

Brief Summary

The purpose of this study is to evaluate the effect of treatment with 0.017% P-321 on Dry Eye Symptoms.

Conditions

Dry Eye Disease

Outcome Measures

Primary Outcomes (1)

• Change From Baseline (Visit 2) to Day 29 (Visit 4) in the Subject-reported Dry Eye Symptom Questionnaire.

  Dry Eye symptoms were obtained using the Symptom Assessment in Dry Eye (SANDE) questionnaire. The questionnaire utilizes separate Visual Analog Scales (VAS) for the frequency and the Severity of symptoms. The scores range from 0 to 100 where 0 = Rarely or Very Mild, and 100 = All the Time or Very Severe for the Frequency and Severity of the symptoms, respectively. The Global Score as reported in the Primary Outcome is obtained by taking the square root of the product of the frequency score multiplied by the severity score. Negative change from baseline indicates improvement.

  Baseline to Day 29

Secondary Outcomes (6)

• Change From Baseline (Visit 2) to Day 29 in Symptom Frequency Scores

  Baseline to Day 29

• Change From Baseline (Visit 2) to Day 29 in Symptom Severity Scores

  Baseline to Day 29

• Change From Baseline to Day 29 in Fluorescein Staining of the Cornea.

  Baseline to Day 29

• Change From Baseline to Day 29 in Lissamine Green Staining of the Conjunctiva.

  Baseline to Day 29

• Number of Participants With at Least 20% Improvement in Symptoms From Baseline to Day 29

  Baseline to Day 29

Study Arms (2)

0.017% P-321 Ophthalmic Solution

EXPERIMENTAL

0.017% P-321 Ophthalmic Solution TID for 28 days.

Drug: P-321 Ophthalmic Solution

Placebo

PLACEBO COMPARATOR

P-321 Ophthalmic Solution Placebo TID for 28 days.

Drug: P-321 Ophthalmic Solution placebo

Interventions

P-321 Ophthalmic Solution DRUG

P-321 Ophthalmic Solution 0.017%

Also known as: P-321

0.017% P-321 Ophthalmic Solution

P-321 Ophthalmic Solution placebo DRUG

Placebo to match P-321 Ophthalmic Solution

Also known as: Placebo

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:

• Provide written informed consent
• Male or female subjects aged 18 to 80 years, inclusive
• Have a history of dry eye disease (DED) in both eyes
• Be on stable regimens of other needed medications
• Have a BCVA of +0.7 or better as assessed by Early Treatment of Diabetic Retinopathy Study (ETDRS)
• Have reported symptoms
• Have the following signs in at least one eye: Schirmer score without anesthesia of \>1 and \<10 mm at 5 minutes and staining of conjunctival and corneal areas of the eye.
• Have normal lid anatomy

You may not qualify if:

• Have undergone refractive eye surgery in the past 12 months
• Have undergone previous eyelid surgery in either eye (External blepharoplasty not resulting in exposure or abnormal blinking is allowed)
• Have lid irregularities or deformities
• Have a history of glaucoma, a history of an elevated lOP within the past year, or an lOP in either eye \> 25 mmHg at the Screening Visit (Visit 1)
• Have any clinically significant, uncontrolled, or unstable medical or surgical conditions that could affect his or her ability to participate
• Have permanent punctal plugs, punctal occlusion, or history of nasolacrimal duct obstruction. Removable punctal plugs are allowed if they have been used regularly for at least 60 days prior to the screening visit. However, if a plug comes out during the study it must be promptly replaced.
• Have clinical findings of severe Meibomian Gland Dysfunction (MGD) in the Study Eye
• Are pregnant or breast feeding
• Use of any investigational product or device within 28 days prior to the Screening Visit or during the study

Sponsors & Collaborators

• Parion Sciences: lead

Study Sites (7)

Sall Research Medical Center

Artesia, California, 90701, United States

Location

Tauber Eye Center

Kansas City, Missouri, 64111, United States

Location

Ophthalmology Associates

St Louis, Missouri, 63131, United States

Location

Comprehensive Eye Care, Ltd.

Washington, Missouri, 63090, United States

Location

UNC Kittner Eye Center

Chapel Hill, North Carolina, 27517, United States

Location

Ocular Surface Center, Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Virginia Eye Consultants

Norfolk, Virginia, 23502, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Results Point of Contact

• Title: Jose Boyer
• Organization: Parion Sciences

jboyer@parion.com

919-313-1182

Study Officials

• Jose Boyer

  Parion Sciences

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2016
• First Posted: July 13, 2016
• Study Start: July 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: October 11, 2018
• Results First Posted: October 11, 2018

Record last verified: 2017-08

Locations

US (7)