A Study of the Safety and Anesthetic Effect of AG-920 Topical Ophthalmic Solution
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Anesthesia Local
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Subjects who provide informed consent and fulfill all the inclusion criteria and none of the exclusion criteria will be randomized in a 1:1 ratio to receive a single dose of AG-920 or identical looking placebo into one (study) eye (2 drops 30 seconds apart).Masking: Double (Participant, Investigator)Masking Description: The Investigator(s), Sponsor, and the subject will be masked to treatment assignment throughout the conduct of the study. Exceptions to this are limited to one statistician at the Contract Research Organization (CRO) who will prepare the randomization code, and three people at the Sponsor who will review the batch records and release product. None of these unmasked persons will be involved in the day to day execution of the study. The masking will be broken after database lock.Primary Purpose: Supportive Care
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
This is a Phase 3, randomized, placebo-controlled, double masked, parallel design study in healthy subjects performed in the US. It is designed to evaluate the safety and anesthetic efficacy of AG-920 Sterile Topical Ophthalmic Solution. In this study, subjects who provide informed consent and fulfi...
This is a Phase 3, randomized, placebo-controlled, double masked, parallel design study in healthy subjects performed in the US. It is designed to evaluate the safety and anesthetic efficacy of AG-920 Sterile Topical Ophthalmic Solution. In this study, subjects who provide informed consent and fulfill all the inclusion criteria and none of the exclusion criteria will be randomized in a 1:1 ratio to receive a single dose of AG-920 or identical looking placebo into the study eye. Subjects will undergo a conjunctival pinch procedure and the pain associated with the pinch rated.
Tracking Information
- NCT #
- NCT04829344
- Collaborators
- Not Provided
- Investigators
- Study Director: Martin Uram, MD Medical Expert
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