Clinical trial NCT02831387: Evaluation of P-321 Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye Disease
Official title: Randomized, Double-Masked, Parallel Group Study of P-321 Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye Disease Assessing Safety and Efficacy Over 28 Days
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Dry Eye Disease
Lead sponsor: Parion Sciences
Sponsor class: INDUSTRY
First posted: 2016-07-13
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: This is a multi-center, randomized, double-masked, placebo-controlled, parallel group Phase 2b trial designed to evaluate symptoms and signs in subjects with mild to moderate dry eye disease. Eligible patients, will be treated with placebo during 2-week placebo run-in period. Subjects will then be randomly assigned in a double-masked, 1:1 ratio to either 0.017% P-321 Ophthalmic Solution or placebo TID for 28 days. This study is designed to evaluate the changes in symptoms. Safety will be assessed throughout the study by adverse events.

Eligibility criteria: Inclusion Criteria:

1. Provide written informed consent
2. Male or female subjects aged 18 to 80 years, inclusive
3. Have a history of dry eye disease (DED) in both eyes
4. Be on stable regimens of other needed medications
5. Have a BCVA of +0.7 or better as assessed by Early Treatment of Diabetic Retinopathy Study (ETDRS)
6. Have reported symptoms
7. 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.
8. Have normal lid anatomy

Exclusion Criteria:

1. Have undergone refractive eye surgery in the past 12 months
2. Have undergone previous eyelid surgery in either eye (External blepharoplasty not resulting in exposure or abnormal blinking is allowed)
3. Have lid irregularities or deformities
4. 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)
5. Have any clinically significant, uncontrolled, or unstable medical or surgical conditions that could affect his or her ability to participate
6. 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.
7. Have clinical findings of severe Meibomian Gland Dysfunction (MGD) in the Study Eye
8. Are pregnant or breast feeding
9. Use of any investigational product or device within 28 days prior to the Screening Visit or during the study

Primary outcomes:
measure: Change From Baseline (Visit 2) to Day 29 (Visit 4) in the Subject-reported Dry Eye Symptom Questionnaire.
timeFrame: Baseline to Day 29
Secondary outcomes:
measure: Change From Baseline (Visit 2) to Day 29 in Symptom Frequency Scores
timeFrame: Baseline to Day 29
measure: Change From Baseline (Visit 2) to Day 29 in Symptom Severity Scores
timeFrame: Baseline to Day 29
measure: Change From Baseline to Day 29 in Fluorescein Staining of the Cornea.
timeFrame: Baseline to Day 29
measure: Change From Baseline to Day 29 in Lissamine Green Staining of the Conjunctiva.
timeFrame: Baseline to Day 29
measure: Number of Participants With at Least 20% Improvement in Symptoms From Baseline to Day 29
timeFrame: Baseline to Day 29
measure: Change From Baseline (Visit 2) to Day 15 (Visit 3) in the Subject-reported Dry Eye Symptom Score.
timeFrame: Baseline to Day 15
Other outcomes:
Locations:
city: Artesia
country: United States
facility: Sall Research Medical Center
state: California
city: Kansas City
country: United States
facility: Tauber Eye Center
state: Missouri
city: Saint Louis
country: United States
facility: Ophthalmology Associates
state: Missouri
city: Washington
country: United States
facility: Comprehensive Eye Care, Ltd.
state: Missouri
city: Chapel Hill
country: United States
facility: UNC Kittner Eye Center
state: North Carolina
city: Houston
country: United States
facility: Ocular Surface Center, Baylor College of Medicine
state: Texas
city: Norfolk
country: United States
facility: Virginia Eye Consultants
state: Virginia
Study officials:
affiliation: Parion Sciences
name: Jose Boyer
role: STUDY_DIRECTOR
References: