Dry Eye Disease Clinical Trial
Official title:
Randomized, Crossover Study of the Pharmacodynamic Activity of P-321 Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye Disease Characterized by Low Tear Volume
The purpose of this Phase 2a study is to assess changes in tear volume by the non-invasive techniques Ultra High Resolution Optical Coherence Tomography (UHR-OCT) following the administration of P-321 Ophthalmic Solution or Placebo in subjects with tear deficient dry eye disease.
This is a single-center, randomized, cross-over placebo controlled study to evaluate the
changes in tear volume by P-321 Ophthalmic Solution and Placebo. The study will enroll
subjects with tear deficient dry eye disease to receive sequentially one of two treatment
sequences: P-321 Ophthalmic Solution then Placebo or Placebo then P-321. The study will
consist of two Phases: In each Phase, subjects will be treated with P-321 Ophthalmic Solution
under the same study design.
Approximately twenty-four eligible subjects will complete the study with approximately 8
subjects participating in Phase 1 and the remainder of the 24 subjects participating in the
phase 2. Decisions on the dose to be used in Phase 2 will be made based on Phase 1 data.
The study will consist of three study visits: a Screening Visit (Visit 1), and two treatment
visits (Visit 2 and Visit 3). The primary and secondary outcome measures will be assessed at
each treatment visit. Safety assessments include adverse events (AEs).
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