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NCT00770133 · ClinicalTrials.gov registry record · Phase 3
Ketotifen/Naphazoline Ophthalmic Solution in the Conjunctival Allergen Challenge Model of Acute Allergic Conjunctivitis.
A Phase 3 study of Allergic Conjunctivitis, sponsored by Bausch & Lomb Incorporated.
- Completed
- Registry status
- Phase 3
- Development phase
- 141
- Enrollment target
- 1
- Study location
NCT00770133: Completed Phase 3 study of Allergic Conjunctivitis, sponsored by Bausch & Lomb Incorporated.
NCT00770133 is a Phase 3 study of Allergic Conjunctivitis that has completed, run by Bausch & Lomb Incorporated. The registered enrollment target is 141 participants, above the 128-participant average among 20 other Allergic Conjunctivitis trials with a reported enrollment target (10% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00770133, a Phase 3 study of Allergic Conjunctivitis, has completed, sponsored by Bausch & Lomb Incorporated.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 141 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to establish the safety and efficacy of ketotifen/naphazoline ophthalmic solution compared to vehicle and its individual components in alleviating the signs and symptoms of conjunctival allergen challenge (CAC)-induced allergic conjunctivitis.
Primary Outcome
Ocular itching was evaluated by the participant at 3, 5, and 7 minutes post challenge. Assessments were made using a 0-4 numerical analog scale, allowing 0.5-unit increments (but disallowing 0.25-unit increments), where: 0.0=None and 4.0=Incapacitating itch with an irresistible urge to rub
Conditions Studied
Interventions
- DRUG Vehicle
- DRUG Ketotifen
- DRUG Ketotifen/naphazoline
- DRUG Naphazoline
Study Locations (1)
Massachusetts
- Ophthalmic Research Consultants, Inc. - North Andover
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 141 participants |
| Start Date | 2010-02 |
| Est. Completion | 2010-06 |
| Phase | Phase 3 |
What the finished NCT00770133 record still lists
NCT00770133 is an interventional study that assigns participants to a tested intervention. The registered 141 participants enrollment target is mid-sized for trials with a published cap, above the 128-participant average among 20 other Allergic Conjunctivitis trials with a reported enrollment target (10% higher).
The record links to 1 condition, with Allergic Conjunctivitis appearing as the primary indexed condition, and to 4 interventions - of which Vehicle is the first listed.
NCT00770133 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT00770133 about?
NCT00770133 is a clinical study titled "Ketotifen/Naphazoline Ophthalmic Solution in the Conjunctival Allergen Challenge Model of Acute Allergic Conjunctivitis.". The purpose of this study is to establish the safety and efficacy of ketotifen/naphazoline ophthalmic solution compared to vehicle and its individual components in alleviating the signs and symptoms of conjunctival allergen challenge (CAC)-induced allergic conjunctivitis.
What is the current status of trial NCT00770133?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 141 participants. The study started on 2010-02. Estimated completion is 2010-06.
What conditions does trial NCT00770133 study?
This clinical trial studies the following conditions: Allergic Conjunctivitis.
What interventions are being tested in trial NCT00770133?
The interventions under investigation include: Vehicle (DRUG), Ketotifen (DRUG), Ketotifen/naphazoline (DRUG), Naphazoline (DRUG).
Who is sponsoring clinical trial NCT00770133?
This trial is sponsored by Bausch & Lomb Incorporated, which has 174 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00770133 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 NCT00770133's enrollment target sits among peer trials
141 6th of 20 higher than 15 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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