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NCT01119287 · ClinicalTrials.gov registry record · Phase 4
Assessing the Efficacy of Maxidex® and Patanol® for the Treatment of Allergic Conjunctivitis
A Phase 4 study of Allergic Conjunctivitis, sponsored by Alcon Research.
- Completed
- Registry status
- Phase 4
- Development phase
- 180
- Enrollment target
- 1
- Study location
NCT01119287: Completed Phase 4 study of Allergic Conjunctivitis, sponsored by Alcon Research.
NCT01119287 is a Phase 4 study of Allergic Conjunctivitis that has completed, run by Alcon Research. The registered enrollment target is 180 participants, above the 126-participant average among 20 other Allergic Conjunctivitis trials with a reported enrollment target (43% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01119287, a Phase 4 study of Allergic Conjunctivitis, has completed, sponsored by Alcon Research.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 180 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study was to evaluate the efficacy of Maxidex and Patanol compared to placebo in patients with allergic conjunctivitis when exposed to controlled allergen levels in an Environmental Exposure Chamber (EEC).
Primary Outcome
Ocular redness ratings were collected for nasal and temporal areas of each eye and scored on a scale from 0 (none) to 4 (extremely severe), 0.5 unit steps permitted. The AUC computation was based on peak redness score (maximum of four areas of redness) at each time point (pre-treatment, 0.25, 0.5, 1.0, 1.5, 2.0, 2.5, 3 hours in the EEC and 3.5, 4, 5, 6, 7, 8, 9, 10 hours in the Clinic). The patient was dosed AM 30 minutes prior to entering the EEC (Visit 6). This outcome measure evaluates a late
Conditions Studied
Interventions
- DRUG Dexamethasone 0.1% ophthalmic suspension
- DRUG Olopatadine hydrochloride 0.1% ophthalmic solution
- OTHER Inactive ingredients, used as placebo
Study Locations (1)
Texas
- Contact Alcon Call Center For Trial Locations - Fort Worth
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 180 participants |
| Start Date | 2010-03 |
| Est. Completion | 2010-09 |
| Phase | Phase 4 |
What the finished NCT01119287 record still lists
NCT01119287 is an interventional study that assigns participants to a tested intervention. The registered 180 participants enrollment target is mid-sized for trials with a published cap, above the 126-participant average among 20 other Allergic Conjunctivitis trials with a reported enrollment target (43% higher).
The record links to 1 condition, with Allergic Conjunctivitis appearing as the primary indexed condition, and to 3 interventions - of which Dexamethasone 0.1% ophthalmic suspension is the first listed.
NCT01119287 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT01119287 about?
NCT01119287 is a clinical study titled "Assessing the Efficacy of Maxidex® and Patanol® for the Treatment of Allergic Conjunctivitis". The purpose of this study was to evaluate the efficacy of Maxidex and Patanol compared to placebo in patients with allergic conjunctivitis when exposed to controlled allergen levels in an Environmental Exposure Chamber (EEC).
What is the current status of trial NCT01119287?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 180 participants. The study started on 2010-03. Estimated completion is 2010-09.
What conditions does trial NCT01119287 study?
This clinical trial studies the following conditions: Allergic Conjunctivitis.
What interventions are being tested in trial NCT01119287?
The interventions under investigation include: Dexamethasone 0.1% ophthalmic suspension (DRUG), Olopatadine hydrochloride 0.1% ophthalmic solution (DRUG), Inactive ingredients, used as placebo (OTHER).
Who is sponsoring clinical trial NCT01119287?
This trial is sponsored by Alcon Research, which has 275 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01119287 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01119287's enrollment target sits among peer trials
180 4th of 20 higher than 17 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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