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
Overview
- Phase
- Phase 2
- Intervention
- P-321 Ophthalmic Solution
- Conditions
- Dry Eye Disease
- Sponsor
- Parion Sciences
- Enrollment
- 47
- Locations
- 7
- Primary Endpoint
- Change From Baseline (Visit 2) to Day 29 (Visit 4) in the Subject-reported Dry Eye Symptom Questionnaire.
- Status
- Terminated
- Last Updated
- 7 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
0.017% P-321 Ophthalmic Solution
0.017% P-321 Ophthalmic Solution TID for 28 days.
Intervention: P-321 Ophthalmic Solution
Placebo
P-321 Ophthalmic Solution Placebo TID for 28 days.
Intervention: P-321 Ophthalmic Solution placebo
Outcomes
Primary Outcomes
Change From Baseline (Visit 2) to Day 29 (Visit 4) in the Subject-reported Dry Eye Symptom Questionnaire.
Time Frame: Baseline to Day 29
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.
Secondary Outcomes
- 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)
- Change From Baseline (Visit 2) to Day 15 (Visit 3) in the Subject-reported Dry Eye Symptom Score.(Baseline to Day 15)