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A Phase 3, Multi-Center Study Evaluating PL9643 in Patients with Dry Eye

NCT05201170 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 575

Last updated 2024-10-17

No results posted yet for this study

Summary

This is a multi-center, double-masked, randomized, vehicle-controlled study testing PL9643, an ophthalmic solution to determine if safe and efficacious for dry eye patients.

After a 2-week run-in period, patients will be randomized equally to the PL9643 ophthalmic solution or vehicle ophthalmic solution administered bilaterally three times a day for 12 weeks.

A Data Monitoring Committee was engaged to review interim data.

Conditions

  • Dry Eye
  • Dry Eye Syndromes

Interventions

DRUG

Vehicle Ophthalmic Solution

Ophthalmic Solution

DRUG

PL9643 Ophthalmic Solution

Ophthalmic Solution

Sponsors & Collaborators

  • Palatin Technologies, Inc

    lead INDUSTRY

Principal Investigators

  • Brian Dodge · Palatin

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-30
Primary Completion
2023-09-01
Completion
2023-11-21
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05201170 on ClinicalTrials.gov