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PL9643 Opthalmic Solution for Dry Eye Syndrome (MELODY-1 Trial)

Phase 3
Waitlist Available
Research Sponsored by Palatin Technologies, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and week 12 (day 85)
Awards & highlights

Summary

This trial is testing PL9643 eye drops to see if they can safely and effectively treat dry eyes. Patients with dry eyes will use these drops regularly over a few months. The drops are expected to help keep the eyes moist and reduce discomfort.

Eligible Conditions
  • Dry Eye Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and week 12 (day 85)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and week 12 (day 85) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Conjunctival Sum Lissamine Green Staining
Inferior Corneal Fluorescein Staining
Ocular Discomfort

Side effects data

From 2014 Phase 4 trial • 40 Patients • NCT01602692
40%
Nausea
10%
Vomiting
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tumescent Solution With Dilute Epinephrine
Tumescent Solution With Dilute Lidocaine and Epinephrine

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: PL9643 Opthalmic SolutionExperimental Treatment1 Intervention
PL9643 ophthalmic solution bilaterally three times a day.
Group II: Vehicle Opthalmic SolutionActive Control1 Intervention
Vehicle opthalmic solution bilaterally three times a day.

Find a Location

Who is running the clinical trial?

Palatin Technologies, IncLead Sponsor
11 Previous Clinical Trials
2,418 Total Patients Enrolled
Jason WintersStudy DirectorPalatin
~64 spots leftby Oct 2025