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Efficacy and Safety of PL9643 Ophthalmic Solution in Subjects With Dry Eye

NCT04268069 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2020-11-13

No results posted yet for this study

Summary

Evaluation of safety and efficacy of PL9643 Ophthalmic Solution compared to placebo for the treatment of the signs and symptoms of dry eye.

Conditions

Interventions

DRUG

PL9643 Ophthalmic Solution

PL9643 Ophthalmic Solution as topical ophthalmic drops administered bilaterally for 12 weeks.

DRUG

Placebo Ophthalmic Solution

Placebo solution as topical ophthalmic drops administered bilaterally for 12 weeks.

Sponsors & Collaborators

  • Palatin Technologies, Inc

    collaborator INDUSTRY

  • ORA, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-14
Primary Completion
2020-10-05
Completion
2020-10-05
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT04268069 on ClinicalTrials.gov