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NCT03368339 · ClinicalTrials.gov registry record · Phase 2
Effectiveness of PR013 Topical Ophthalmic Drops Compared to Vehicle for the Treatment of Allergic Conjunctivitis
A Phase 2 study of Allergic Conjunctivitis, sponsored by Realm Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 96
- Enrollment target
- 1
- Study location
NCT03368339: Completed Phase 2 study of Allergic Conjunctivitis, sponsored by Realm Therapeutics.
NCT03368339 is a Phase 2 study of Allergic Conjunctivitis that has completed, run by Realm Therapeutics. The registered enrollment target is 96 participants, below the 130-participant average among 20 other Allergic Conjunctivitis trials with a reported enrollment target (26% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03368339, a Phase 2 study of Allergic Conjunctivitis, has completed, sponsored by Realm Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 96 participants
- Enrollment target
- 1
- Study location
Study Summary
To evaluate the efficacy and safety of PR013 topical ophthalmic drops (0.045% and 0.06%) compared to vehicle for the treatment of the signs and symptoms of allergic conjunctivitis using a modified Conjunctival Allergen Challenge Model (Ora-CAC®).
Primary Outcome
The method of assessment for this outcome is the Ora Calibra(TM) Conjunctival Allergen Challenge Ocular Itching Scale
Conditions Studied
Interventions
- DRUG Vehicle
- DRUG PR013 (0.045%)
- DRUG PR013 (0.06%)
Study Locations (1)
Pennsylvania
- Principal Investigator - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 96 participants |
| Start Date | 2017-12-10 |
| Est. Completion | 2018-01-28 |
| Phase | Phase 2 |
What the finished NCT03368339 record still lists
NCT03368339 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 96 participants, a relatively small participant target, below the 130-participant average among 20 other Allergic Conjunctivitis trials with a reported enrollment target (26% lower).
The record links to 1 condition, with Allergic Conjunctivitis appearing as the primary indexed condition, and to 3 interventions - of which Vehicle is the first listed.
NCT03368339 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT03368339 about?
NCT03368339 is a clinical study titled "Effectiveness of PR013 Topical Ophthalmic Drops Compared to Vehicle for the Treatment of Allergic Conjunctivitis". To evaluate the efficacy and safety of PR013 topical ophthalmic drops (0.045% and 0.06%) compared to vehicle for the treatment of the signs and symptoms of allergic conjunctivitis using a modified Conjunctival Allergen Challenge Model (Ora-CAC®).
What is the current status of trial NCT03368339?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 96 participants. The study started on 2017-12-10. Estimated completion is 2018-01-28.
What conditions does trial NCT03368339 study?
This clinical trial studies the following conditions: Allergic Conjunctivitis.
What interventions are being tested in trial NCT03368339?
The interventions under investigation include: Vehicle (DRUG), PR013 (0.045%) (DRUG), PR013 (0.06%) (DRUG).
Who is sponsoring clinical trial NCT03368339?
This trial is sponsored by Realm Therapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03368339 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03368339's enrollment target sits among peer trials
96 12th of 20 higher than 9 of 20 other Allergic Conjunctivitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Allergic Conjunctivitis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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