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A Phase 3, Multi-Center Study Evaluating PL9643 in Patients with Dry Eye (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 visit 6 (day 85), change from pre-cae to post-cae
Awards & highlights
No Placebo-Only Group
Pivotal Trial

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 ~change from baseline to visit 6 (day 85), pre-cae
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to visit 6 (day 85), pre-cae 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
Ocular Pain
Secondary study objectives
Eye Discomfort for Hyper-responders versus Vehicle in hyper-responder sub-population
Eye Dryness for Hyper-Responders versus Vehicle in hyper-responder sub-population
Foreign Body Sensation for Hyper-Responders
+7 more
Other study objectives
Eye Discomfort for Hyper-responders
Pain for Hyper-Responders
Pain for ITT

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: PL9643 Ophthalmic SolutionExperimental Treatment1 Intervention
PL9643 ophthalmic solution bilaterally three times a day.
Group II: Vehicle Ophthalmic SolutionActive Control1 Intervention
Vehicle ophthalmic solution bilaterally three times a day.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PL9643 Ophthalmic Solution
2020
Completed Phase 3
~740

Find a Location

Who is running the clinical trial?

Palatin Technologies, IncLead Sponsor
11 Previous Clinical Trials
2,389 Total Patients Enrolled
Brian DodgeStudy DirectorPalatin
Jason WintersStudy DirectorPalatin
~147 spots leftby Dec 2025
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