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

2020-02-17 18:20:53 | BioPortfolio

Summary

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

Description

The clinical trial is a Phase 2, multi center, randomized, double masked and placebo controlled study.

During a 14-day study run-in period (for the purpose of subject selection) prior to randomization, all subjects will receive Placebo Ophthalmic Solution (vehicle) bilaterally. During the screening period, exposure to the CAE® will be conducted to ascertain eligibility to enter the study at Visit 1 and Visit 2. Those who qualify at Visit 2 will be randomized to receive study drug in a double-masked fashion for 12 weeks. The CAE® exposure will occur at all Visits.

Study Design

Conditions

Dry Eye Disease

Intervention

PL9643 Ophthalmic Solution, Placebo Ophthalmic Solution

Location

Andover Eye Associates
Andover
Massachusetts
United States
01810

Status

Recruiting

Source

ORA, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2020-02-17T18:20:53-0500

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Medical and Biotech [MESH] Definitions

Hypertonic sodium chloride solution. A solution having an osmotic pressure greater than that of physiologic salt solution (0.9 g NaCl in 100 ml purified water).

A sensory branch of the trigeminal (5th cranial) nerve. The ophthalmic nerve carries general afferents from the superficial division of the face including the eyeball, conjunctiva, upper eyelid, upper nose, nasal mucosa, and scalp.

The pressure required to prevent the passage of solvent through a semipermeable membrane that separates a pure solvent from a solution of the solvent and solute or that separates different concentrations of a solution. It is proportional to the osmolality of the solution.

Solution that is usually 10 percent glucose but may be higher. An isotonic solution of glucose is 5 percent.

The washing of the VAGINA cavity or surface with a solution. Agents or drugs can be added to the irrigation solution.

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