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NCT01109173 · ClinicalTrials.gov registry record · Phase 3
Confirmatory Study Nepafenac 0.3%
A Phase 3 study, sponsored by Alcon Research.
- Completed
- Registry status
- Phase 3
- Development phase
- 2,120
- Enrollment target
NCT01109173: Completed Phase 3 study, sponsored by Alcon Research.
NCT01109173 is a Phase 3 study that has completed, run by Alcon Research. The registered enrollment target is 2,120 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (175% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01109173, a Phase 3 study, has completed, sponsored by Alcon Research.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 2,120 participants
- Enrollment target
Study Summary
The purpose of this study was to assess the safety and efficacy of an investigational eye drop intended for the prevention and treatment of inflammation (swelling and redness) and pain in the eye after cataract extraction.
Primary Outcome
Ocular inflammation was assessed by the investigator during slit lamp examination. Aqueous cells were scored on a 5-unit scale from 0 (none) to 4 (\> 30 cells), and aqueous flare (protein escaping from dilated vessels) was scored on a 4-unit scale from 0 (no visible flare when compared with the normal eye) to 3 (severe - very dense flare). To be considered cured, the patient must have had a score of 0 for both cells and flare.
Interventions
- DRUG Nepafenac Ophthalmic Suspension, 0.3%
- DRUG Nepafenac Ophthalmic Suspension, 0.1%
- OTHER Nepafenac Ophthalmic Suspension 0.3% Vehicle
- OTHER NEVANAC Vehicle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,120 participants |
| Start Date | 2010-06 |
| Phase | Phase 3 |
What the finished NCT01109173 record still lists
NCT01109173 is an interventional study that assigns participants to a tested intervention. Its 2,120 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (175% higher).
The record links to 0 conditions, and to 4 interventions - of which Nepafenac Ophthalmic Suspension, 0.3% is the first listed.
NCT01109173 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01109173 about?
NCT01109173 is a clinical study titled "Confirmatory Study Nepafenac 0.3%". The purpose of this study was to assess the safety and efficacy of an investigational eye drop intended for the prevention and treatment of inflammation (swelling and redness) and pain in the eye after cataract extraction.
What is the current status of trial NCT01109173?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,120 participants. The study started on 2010-06.
What interventions are being tested in trial NCT01109173?
The interventions under investigation include: Nepafenac Ophthalmic Suspension, 0.3% (DRUG), Nepafenac Ophthalmic Suspension, 0.1% (DRUG), Nepafenac Ophthalmic Suspension 0.3% Vehicle (OTHER), NEVANAC Vehicle (OTHER).
Who is sponsoring clinical trial NCT01109173?
This trial is sponsored by Alcon Research, which has 275 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01109173's enrollment target sits among peer trials
2,120 98th of 2000 higher than 1,903 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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