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

Dry Eye Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04268069
• Other study ID #: PL9643-201
• Status: Completed
• Phase: Phase 2
• Start date: February 14, 2020
• Est. completion date: October 5, 2020

Study information

• Verified date: November 2020
• Source: ORA, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: October 5, 2020
• Est. primary completion date: October 5, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye Disease
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

Drug:
• PL9643 Ophthalmic Solution
PL9643 Ophthalmic Solution as topical ophthalmic drops administered bilaterally for 12 weeks.
• Placebo Ophthalmic Solution
Placebo solution as topical ophthalmic drops administered bilaterally for 12 weeks.

Locations

Country	Name	City	State
United States	Andover Eye Associates	Andover	Massachusetts
United States	Total Eye Care, P.A.	Memphis	Tennessee
United States	Andover Eye Associates	Raynham	Massachusetts
United States	Vita Eye Clinc	Shelby	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
ORA, Inc.	Palatin Technologies

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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