NCT04268069

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Feb 2020

Shorter than P25 for phase_2

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 11, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 13, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

February 14, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 5, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 5, 2020

Completed
Last Updated

November 13, 2020

Status Verified

November 1, 2020

Enrollment Period

8 months

First QC Date

February 11, 2020

Last Update Submit

November 12, 2020

Conditions

Dry Eye Disease

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • Corneal Fluorescein Staining Using The Ora Calibra Scale

    12 weeks

  • Conjunctival Lissamine Green Staining Using The Ora Calibra Scale

    12 weeks

  • Conjunctival Redness Using The Ora Calibra Scale

    12 weeks

Study Arms (2)

Placebo Ophthalmic Solution (vehicle)

PLACEBO COMPARATOR

vehicle

Drug: Placebo Ophthalmic Solution

PL9643 Ophthalmic Solution

ACTIVE COMPARATOR

PL9643 Ophthalmic Solution

Drug: PL9643 Ophthalmic Solution

Interventions

PL9643 Ophthalmic SolutionDRUG

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

PL9643 Ophthalmic Solution
Placebo Ophthalmic SolutionDRUG

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

Placebo Ophthalmic Solution (vehicle)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Andover Eye Associates

Andover, Massachusetts, 01810, United States

Location

Andover Eye Associates

Raynham, Massachusetts, 02767, United States

Location

Vita Eye Clinc

Shelby, North Carolina, 28150, United States

Location

Total Eye Care, P.A.

Memphis, Tennessee, 38119, United States

Location

Related Publications (1)

  • 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.

    PMID: 37677000DERIVED

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2020

First Posted

February 13, 2020

Study Start

February 14, 2020

Primary Completion

October 5, 2020

Study Completion

October 5, 2020

Last Updated

November 13, 2020

Record last verified: 2020-11

Locations

US(4)