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Efficacy and Safety of PL9643 Ophthalmic Solution in Subjects With Dry Eye

Primary Purpose

Dry Eye Disease

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
PL9643 Ophthalmic Solution
Placebo Ophthalmic Solution
Sponsored by
ORA, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Be at least 18 years of age.
  • Provided written informed consent.
  • Have a reported history of dry eye
  • Have a history of use or desire to use eye drops for dry eye symptoms
  • Have corrected visual acuity greater than or equal to +0.7 in both eyes

Exclusion Criteria:

  • Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal)
  • Have any planned ocular and/or lid surgeries over the study period.
  • Have an uncontrolled systemic disease.
  • Be a woman who is pregnant, nursing or planning a pregnancy.
  • Be a woman of childbearing potential who is not using an acceptable means of birth control
  • Have a known allergy and/or sensitivity to the test article or its components.
  • Have a condition or be in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
  • Have used an investigational drug or device within 30 days of Visit 1
  • Be unable or unwilling to follow instructions, including participation in all study assessments and visits

Sites / Locations

  • Andover Eye Associates
  • Andover Eye Associates
  • Vita Eye Clinc
  • Total Eye Care, P.A.

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo Ophthalmic Solution (vehicle)

PL9643 Ophthalmic Solution

Arm Description

vehicle

PL9643 Ophthalmic Solution

Outcomes

Primary Outcome Measures

Inferior Corneal Fluorescein Staining Using The Ora Calibra Scale
An assessment of corneal fluorescein staining using the 0 [none] to 4 [worst] Ora Calibra Scale prior to and following exposure to a challenge in a controlled adverse environment (CAE)
Ocular Discomfort Using The Ora Calibra Scale
A patient-reported subjective assessment of ocular discomfort using the 0 [none] to 4 [worst] Ora Calibra Scale recorded at each study visit throughout the treatment period

Secondary Outcome Measures

Corneal Fluorescein Staining Using The Ora Calibra Scale
An assessment of corneal fluorescein staining using the 0 [none] to 4 [worst] Ora Calibra Scale prior to and following exposure to a challenge in a controlled adverse environment (CAE)
Conjunctival Lissamine Green Staining Using The Ora Calibra Scale
An assessment of conjunctival lissamine green staining using the 0 [none] to 4 [worst] Ora Calibra Scale prior to and following exposure to a challenge in a controlled adverse environment (CAE)
Conjunctival Redness Using The Ora Calibra Scale
An assessment of conjunctival redness using the 0 [none] to 4 [worst] Ora Calibra Scale prior to and following exposure to a challenge in a controlled adverse environment (CAE)

Full Information

First Posted
February 11, 2020
Last Updated
November 12, 2020
Sponsor
ORA, Inc.
Collaborators
Palatin Technologies, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT04268069
Brief Title
Efficacy and Safety of PL9643 Ophthalmic Solution in Subjects With Dry Eye
Official Title
A Phase 2, Multi-center, Randomized, Double-Masked and Placebo-Controlled Study Evaluating the Efficacy and Safety of PL9643 Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
February 14, 2020 (Actual)
Primary Completion Date
October 5, 2020 (Actual)
Study Completion Date
October 5, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ORA, Inc.
Collaborators
Palatin Technologies, Inc

4. Oversight

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

5. Study Description

Brief Summary
Evaluation of safety and efficacy of PL9643 Ophthalmic Solution compared to placebo for the treatment of the signs and symptoms of dry eye.
Detailed Description
The clinical trial is a Phase 2, multi center, randomized, double masked and placebo controlled study. During a 14-day study run-in period (for the purpose of subject selection) prior to randomization, all subjects will receive Placebo Ophthalmic Solution (vehicle) bilaterally. During the screening period, exposure to the CAE® will be conducted to ascertain eligibility to enter the study at Visit 1 and Visit 2. Those who qualify at Visit 2 will be randomized to receive study drug in a double-masked fashion for 12 weeks. The CAE® exposure will occur at all Visits.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo Ophthalmic Solution (vehicle)
Arm Type
Placebo Comparator
Arm Description
vehicle
Arm Title
PL9643 Ophthalmic Solution
Arm Type
Active Comparator
Arm Description
PL9643 Ophthalmic Solution
Intervention Type
Drug
Intervention Name(s)
PL9643 Ophthalmic Solution
Intervention Description
PL9643 Ophthalmic Solution as topical ophthalmic drops administered bilaterally for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo Ophthalmic Solution
Intervention Description
Placebo solution as topical ophthalmic drops administered bilaterally for 12 weeks.
Primary Outcome Measure Information:
Title
Inferior Corneal Fluorescein Staining Using The Ora Calibra Scale
Description
An assessment of corneal fluorescein staining using the 0 [none] to 4 [worst] Ora Calibra Scale prior to and following exposure to a challenge in a controlled adverse environment (CAE)
Time Frame
Day 85
Title
Ocular Discomfort Using The Ora Calibra Scale
Description
A patient-reported subjective assessment of ocular discomfort using the 0 [none] to 4 [worst] Ora Calibra Scale recorded at each study visit throughout the treatment period
Time Frame
Day 85
Secondary Outcome Measure Information:
Title
Corneal Fluorescein Staining Using The Ora Calibra Scale
Description
An assessment of corneal fluorescein staining using the 0 [none] to 4 [worst] Ora Calibra Scale prior to and following exposure to a challenge in a controlled adverse environment (CAE)
Time Frame
12 weeks
Title
Conjunctival Lissamine Green Staining Using The Ora Calibra Scale
Description
An assessment of conjunctival lissamine green staining using the 0 [none] to 4 [worst] Ora Calibra Scale prior to and following exposure to a challenge in a controlled adverse environment (CAE)
Time Frame
12 weeks
Title
Conjunctival Redness Using The Ora Calibra Scale
Description
An assessment of conjunctival redness using the 0 [none] to 4 [worst] Ora Calibra Scale prior to and following exposure to a challenge in a controlled adverse environment (CAE)
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Be at least 18 years of age. Provided written informed consent. Have a reported history of dry eye Have a history of use or desire to use eye drops for dry eye symptoms Have corrected visual acuity greater than or equal to +0.7 in both eyes Exclusion Criteria: Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal) Have any planned ocular and/or lid surgeries over the study period. Have an uncontrolled systemic disease. Be a woman who is pregnant, nursing or planning a pregnancy. Be a woman of childbearing potential who is not using an acceptable means of birth control Have a known allergy and/or sensitivity to the test article or its components. Have a condition or be in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study Have used an investigational drug or device within 30 days of Visit 1 Be unable or unwilling to follow instructions, including participation in all study assessments and visits
Facility Information:
Facility Name
Andover Eye Associates
City
Andover
State/Province
Massachusetts
ZIP/Postal Code
01810
Country
United States
Facility Name
Andover Eye Associates
City
Raynham
State/Province
Massachusetts
ZIP/Postal Code
02767
Country
United States
Facility Name
Vita Eye Clinc
City
Shelby
State/Province
North Carolina
ZIP/Postal Code
28150
Country
United States
Facility Name
Total Eye Care, P.A.
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Efficacy and Safety of PL9643 Ophthalmic Solution in Subjects With Dry Eye

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