ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02831387
Recruitment Status : Terminated
First Posted : July 13, 2016
Results First Posted : October 11, 2018
Last Update Posted : October 11, 2018
Sponsor:
Information provided by (Responsible Party):
Parion Sciences

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

Condition or disease Intervention/treatment Phase
Dry Eye Disease Drug: P-321 Ophthalmic Solution Drug: P-321 Ophthalmic Solution placebo Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : July 2016
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Diseases

Arm Intervention/treatment
Experimental: 0.017% P-321 Ophthalmic Solution
0.017% P-321 Ophthalmic Solution TID for 28 days.
Drug: P-321 Ophthalmic Solution
P-321 Ophthalmic Solution 0.017%
Other Name: P-321

Placebo Comparator: Placebo
P-321 Ophthalmic Solution Placebo TID for 28 days.
Drug: P-321 Ophthalmic Solution placebo
Placebo to match P-321 Ophthalmic Solution
Other Name: Placebo




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Change From Baseline (Visit 2) to Day 29 in Symptom Frequency Scores [ Time Frame: Baseline to Day 29 ]
    Dry Eye symptom frequency was obtained using the Symptom Assessment in Dry Eye (SANDE) questionnaire. The questionnaire utilizes a 100 mm horizontal Visual Analog Scale (VAS). The scores range from 0 to 100 where 0 = Rarely and 100 = All the Time. A negative change from baseline indicates improvement.

  2. Change From Baseline (Visit 2) to Day 29 in Symptom Severity Scores [ Time Frame: Baseline to Day 29 ]
    Dry Eye symptom severity was obtained using the Symptom Assessment in Dry Eye (SANDE) questionnaire. The questionnaire utilizes a 100 mm horizontal Visual Analog Scales (VAS). The scores range from 0 to 100 where 0 = Very Mild and 100 = Very Severe. A negative change from baseline indicates improvement.

  3. Change From Baseline to Day 29 in Fluorescein Staining of the Cornea. [ Time Frame: Baseline to Day 29 ]
    Corneal staining was performed to grade the corneal epithelial cell injury as measured by fluorescence using slit lamp examination. The staining was graded with the NEI scale. The corneal surface is divided into 5 corneal regions (1, Central; 2, Inferior; 3, Nasal; 4, Temporal; 5, Superior). The scores for each of these 5 regions ranged from 0 to 3 (0=no staining; 1=staining with low density; 2=staining with moderate density; 3=staining with severe density). The total staining score (sum of all regions, maximal score =15) is reported. A negative change from baseline indicates improvement.

  4. Change From Baseline to Day 29 in Lissamine Green Staining of the Conjunctiva. [ Time Frame: Baseline to Day 29 ]
    Conjunctival staining was performed to grade the conjunctival epithelial cell injury as measured by Lissamine Green using slit-lamp examination. The staining was graded with the NEI scale. The bulbar conjunctival surface is divided into 6 regions (1, Temporal; 2 Temporal Superior; 3, Temporal Inferior; 4, Nasal Superior; 5, Nasal Inferior; 6, Nasal). The scores for each of these 6 regions ranged from 0 to 3 (0=no staining; 1=staining with low density; 2=staining with moderate density; 3=staining with severe density). The total staining score (sum of all regions, maximal score =18) is reported. A negative change from baseline indicates improvement.

  5. Number of Participants With at Least 20% Improvement in Symptoms From Baseline to Day 29 [ Time Frame: Baseline to Day 29 ]
    Improvement in symptoms was evaluated 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 is obtained by taking the square root of the product of the frequency score multiplied by the severity score. Lower scores indicate improvement in symptoms.

  6. Change From Baseline (Visit 2) to Day 15 (Visit 3) in the Subject-reported Dry Eye Symptom Score. [ Time Frame: Baseline to Day 15 ]
    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. A negative change from baseline indicates improvement.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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): NCT02831387


Locations
United States, California
Sall Research Medical Center
Artesia, California, United States, 90701
United States, Missouri
Tauber Eye Center
Kansas City, Missouri, United States, 64111
Ophthalmology Associates
Saint Louis, Missouri, United States, 63131
Comprehensive Eye Care, Ltd.
Washington, Missouri, United States, 63090
United States, North Carolina
UNC Kittner Eye Center
Chapel Hill, North Carolina, United States, 27517
United States, Texas
Ocular Surface Center, Baylor College of Medicine
Houston, Texas, United States, 77030
United States, Virginia
Virginia Eye Consultants
Norfolk, Virginia, United States, 23502
Sponsors and Collaborators
Parion Sciences
Investigators
Study Director: Jose Boyer Parion Sciences
  Study Documents (Full-Text)

Documents provided by Parion Sciences:
Study Protocol  [PDF] February 10, 2017
Statistical Analysis Plan  [PDF] August 8, 2017


Responsible Party: Parion Sciences
ClinicalTrials.gov Identifier: NCT02831387     History of Changes
Other Study ID Numbers: P-321-202
First Posted: July 13, 2016    Key Record Dates
Results First Posted: October 11, 2018
Last Update Posted: October 11, 2018
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Pharmaceutical Solutions
Ophthalmic Solutions