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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

MELODY-1 Trial Summary

This trial will test an eye solution to see if it is safe and effective for dry eye patients.

Eligible Conditions
  • Dry Eye Syndrome

MELODY-1 Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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

MELODY-1 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
10 Previous Clinical Trials
2,358 Total Patients Enrolled
Jason WintersStudy DirectorPalatin

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you please remind us of the safety hazards associated with PL9643 Opthalmic Solution?

"PL9643 Opthalmic Solution is a phase 3 trial drug, meaning that there is both some efficacy data as well as multiple rounds of safety data. Consequently, our team has decided that it merits a score of 3 out of 3 for safety."

Answered by AI

Are there any more available spots for people in this clinical trial?

"According to the website clinicaltrials.gov, this study is still enrolling patients. The listing was originally published on December 30th, 2021 and updated January 20th, 2022."

Answered by AI

Who else is applying?

What state do they live in?
District of Columbia
Massachusetts
How old are they?
18 - 65
What site did they apply to?
Palatin Clinical Site #1
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Phase 3, Multi-Center Study Evaluating PL9643 in Patients With Dry Eye
2021. "A Phase 3, Multi-Center Study Evaluating PL9643 in Patients With Dry Eye". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05201170.
All > Dry Eye
~74 spots leftby Apr 2025
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