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

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

Evaluation of safety and efficacy of PL9643 Ophthalmic Solution compared to placebo for the treatment of the signs and symptoms of dry eye.

Study Overview

• Status: Completed
• Conditions: Dry Eye Disease
• Intervention / Treatment: Drug: Placebo Ophthalmic Solution; Drug: PL9643 Ophthalmic Solution

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.

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Andover, Massachusetts, United States, 01810
      • Andover Eye Associates
    • Raynham, Massachusetts, United States, 02767
      • Andover Eye Associates
  • North Carolina
    • Shelby, North Carolina, United States, 28150
      • Vita Eye Clinc
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Total Eye Care, P.A.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo Ophthalmic Solution (vehicle); vehicle	Drug: Placebo Ophthalmic Solution; Placebo solution as topical ophthalmic drops administered bilaterally for 12 weeks.
ACTIVE_COMPARATOR: PL9643 Ophthalmic Solution	Drug: PL9643 Ophthalmic Solution; PL9643 Ophthalmic Solution as topical ophthalmic drops administered bilaterally for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Day 85
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	Day 85

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	12 weeks
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)	12 weeks
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)	12 weeks

Collaborators and Investigators

• Sponsor: ORA, Inc.
• Collaborators: Palatin Technologies, Inc

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 14, 2020
• Primary Completion (ACTUAL): October 5, 2020
• Study Completion (ACTUAL): October 5, 2020

Study Registration Dates

• First Submitted: February 11, 2020
• First Submitted That Met QC Criteria: February 11, 2020
• First Posted (ACTUAL): February 13, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 13, 2020
• Last Update Submitted That Met QC Criteria: November 12, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Eye Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Ophthalmic Solutions; Pharmaceutical Solutions
• Other Study ID Numbers: PL9643-201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No