Clinical trial NCT04268069: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dry Eye Disease
Lead sponsor: ORA, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Palatin Technologies, Inc
First posted: 2020-02-13
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Inferior Corneal Fluorescein Staining Using The Ora Calibra Scale
timeFrame: Day 85
measure: Ocular Discomfort Using The Ora Calibra Scale
timeFrame: Day 85
Secondary outcomes:
measure: Corneal Fluorescein Staining Using The Ora Calibra Scale
timeFrame: 12 weeks
measure: Conjunctival Lissamine Green Staining Using The Ora Calibra Scale
timeFrame: 12 weeks
measure: Conjunctival Redness Using The Ora Calibra Scale
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Andover
country: United States
facility: Andover Eye Associates
state: Massachusetts
city: Raynham
country: United States
facility: Andover Eye Associates
state: Massachusetts
city: Shelby
country: United States
facility: Vita Eye Clinc
state: North Carolina
city: Memphis
country: United States
facility: Total Eye Care, P.A.
state: Tennessee
Study officials:
References: