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

NCT ID: NCT04268069

Last Updated: 2020-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-14

Study Completion Date

2020-10-05

Brief Summary

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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

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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.

Conditions

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Dry Eye Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo Ophthalmic Solution (vehicle)

vehicle

Group Type PLACEBO_COMPARATOR

Placebo Ophthalmic Solution

Intervention Type DRUG

Placebo solution as topical ophthalmic drops administered bilaterally for 12 weeks.

PL9643 Ophthalmic Solution

PL9643 Ophthalmic Solution

Group Type ACTIVE_COMPARATOR

PL9643 Ophthalmic Solution

Intervention Type DRUG

PL9643 Ophthalmic Solution as topical ophthalmic drops administered bilaterally for 12 weeks.

Interventions

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PL9643 Ophthalmic Solution

PL9643 Ophthalmic Solution as topical ophthalmic drops administered bilaterally for 12 weeks.

Intervention Type DRUG

Placebo Ophthalmic Solution

Placebo solution as topical ophthalmic drops administered bilaterally for 12 weeks.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Palatin Technologies, Inc

INDUSTRY

Sponsor Role collaborator

ORA, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Andover Eye Associates

Andover, Massachusetts, United States

Site Status

Andover Eye Associates

Raynham, Massachusetts, United States

Site Status

Vita Eye Clinc

Shelby, North Carolina, United States

Site Status

Total Eye Care, P.A.

Memphis, Tennessee, United States

Site Status

Countries

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United States

References

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Evans D, Kenyon K, Ousler G, Watson M, Vollmer P, McLaurin EB, Torkildsen G, Winters J, Dodd J, Jordan R, Wills ST, Spana C. Efficacy and Safety of the Melanocortin Pan-Agonist PL9643 in a Phase 2 Study of Patients with Dry Eye Disease. J Ocul Pharmacol Ther. 2023 Nov;39(9):600-610. doi: 10.1089/jop.2023.0056. Epub 2023 Sep 7.

Reference Type DERIVED
PMID: 37677000 (View on PubMed)

Other Identifiers

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PL9643-201

Identifier Type: -

Identifier Source: org_study_id