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NCT01534195 · ClinicalTrials.gov registry record · Phase 4
Evaluation of the Efficacy of Topical Ophthalmic Steroids in a Modified Conjunctival Allergen Challenge (CAC) Model
A Phase 4 study of Allergic Conjunctivitis, sponsored by ORA.
- Completed
- Registry status
- Phase 4
- Development phase
- 11
- Enrollment target
- 1
- Study location
NCT01534195: Completed Phase 4 study of Allergic Conjunctivitis, sponsored by ORA.
NCT01534195 is a Phase 4 study of Allergic Conjunctivitis that has completed, run by ORA. The registered enrollment target is 11 participants, below the 134-participant average among 20 other Allergic Conjunctivitis trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01534195, a Phase 4 study of Allergic Conjunctivitis, has completed, sponsored by ORA.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 11 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to evaluate the effectiveness of the modified Conjunctival Allergen Challenge (CAC) and observe how the produced allergic inflammation reacts to treatment with a proven ocular anti-inflammatory medication, Prednisolone, assessed by the following measures: * Ocular itching * Conjunctival redness
Primary Outcome
Ocular itching, as assessed by the participant, was measured on a 4-point scale 5 minutes after the conjunctival allergen challenge (CAC). 0 was best (no itching), and 4 was worst (worst itching).
Conditions Studied
Interventions
- DRUG Prednisolone Sodium Phosphate Ophthalmic Solution 1%
- DRUG Tears Naturale II Ophthalmic Solution
Study Locations (1)
Massachusetts
- Andover Eye Associates - Andover
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2012-01 |
| Est. Completion | 2012-02 |
| Phase | Phase 4 |
What the finished NCT01534195 record still lists
NCT01534195 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 134-participant average among 20 other Allergic Conjunctivitis trials with a reported enrollment target (92% lower).
The record links to 1 condition, with Allergic Conjunctivitis appearing as the primary indexed condition, and to 2 interventions - of which Prednisolone Sodium Phosphate Ophthalmic Solution 1% is the first listed.
NCT01534195 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT01534195 about?
NCT01534195 is a clinical study titled "Evaluation of the Efficacy of Topical Ophthalmic Steroids in a Modified Conjunctival Allergen Challenge (CAC) Model". The purpose of this study is to evaluate the effectiveness of the modified Conjunctival Allergen Challenge (CAC) and observe how the produced allergic inflammation reacts to treatment with a proven ocular anti-inflammatory medication, Prednisolone, assessed by the following measures: * Ocular itch...
What is the current status of trial NCT01534195?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 11 participants. The study started on 2012-01. Estimated completion is 2012-02.
What conditions does trial NCT01534195 study?
This clinical trial studies the following conditions: Allergic Conjunctivitis.
What interventions are being tested in trial NCT01534195?
The interventions under investigation include: Prednisolone Sodium Phosphate Ophthalmic Solution 1% (DRUG), Tears Naturale II Ophthalmic Solution (DRUG).
Who is sponsoring clinical trial NCT01534195?
This trial is sponsored by ORA, which has 19 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01534195 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01534195's enrollment target sits among peer trials
11 21st of 20 the lowest 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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