NCT05201170Phase 3Completed

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

Study sponsor: Palatin Technologies, Inc · PTN

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2023-09-01Actual

Enrollment · participants575Actual

Source updated2024-10-17Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Study details

Conditions studied

Dry Eye; Dry Eye Syndromes

Treatments or interventions studied

Vehicle Ophthalmic SolutionDrugAlso known as Control
PL9643 Ophthalmic SolutionDrugAlso known as Active study medication

Primary outcomes · main study measures

Read the study measures

measure: Conjunctival Sum Lissamine Green Staining; description: Measured by the Ora Calibra® Scale. Change from Baseline to week 12.; timeFrame: Visit 6 (Day 85), Change from Pre-CAE to Post-CAE; measure: Ocular Pain; description: As Measured by Visual Analog Scale (VAS). PL9643 versus Vehicle, in hyper-responder sub-population. Hyper-responder sub-population is defined as those patients achieving a VAS score of 4 or greater within the first 30 minutes of being challenged in the CAE® (clinical symptom) at Visit 2.; timeFrame: Change from Pre-CAE to Post-CAE at Visit 6 (Day 85)

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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