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NCT00769886 · ClinicalTrials.gov registry record · Phase 3
Ketotifen/Naphazoline Ophthalmic Solution in the Conjunctival Allergen Challenge Model of Allergic Conjunctivitis.
A Phase 3 study, sponsored by Bausch & Lomb Incorporated.
- Completed
- Registry status
- Phase 3
- Development phase
- 144
- Enrollment target
NCT00769886: Completed Phase 3 study, sponsored by Bausch & Lomb Incorporated.
NCT00769886 is a Phase 3 study that has completed, run by Bausch & Lomb Incorporated. The registered enrollment target is 144 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00769886, a Phase 3 study, has completed, sponsored by Bausch & Lomb Incorporated.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 144 participants
- Enrollment target
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.
Interventions
- DRUG Vehicle
- DRUG Ketotifen
- DRUG Ketotifen/naphazoline
- DRUG Naphazoline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 144 participants |
| Start Date | 2008-10 |
| Est. Completion | 2009-06 |
| Phase | Phase 3 |
What the finished NCT00769886 record still lists
NCT00769886 is an interventional study that assigns participants to a tested intervention. The registered 144 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 4 interventions - of which Vehicle is the first listed.
NCT00769886 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00769886 about?
NCT00769886 is a clinical study titled "Ketotifen/Naphazoline Ophthalmic Solution in the Conjunctival Allergen Challenge Model of 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 NCT00769886?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 144 participants. The study started on 2008-10. Estimated completion is 2009-06.
What interventions are being tested in trial NCT00769886?
The interventions under investigation include: Vehicle (DRUG), Ketotifen (DRUG), Ketotifen/naphazoline (DRUG), Naphazoline (DRUG).
Who is sponsoring clinical trial NCT00769886?
This trial is sponsored by Bausch & Lomb Incorporated, which has 174 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00769886's enrollment target sits among peer trials
144 1559th of 2000 higher than 442 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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