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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and week 12 (day 85)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and week 12 (day 85)
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 • NCT0160269240%
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.
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Who is running the clinical trial?
Palatin Technologies, IncLead Sponsor
11 Previous Clinical Trials
2,418 Total Patients Enrolled
Jason WintersStudy DirectorPalatin
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