---
title: A Comparison of Post Phacoemulsification Aqueous Flare in Patients Using Ketorolac 0.45% 2 Times Daily (BID) and Bromfenac 0.09% 2 Times Daily (BID)
nct_id: NCT01023724
overall_status: COMPLETED
phase: PHASE4
sponsor: Bucci Laser Vision Institute
study_type: INTERVENTIONAL
primary_condition: Post Operative Anterior Chamber Inflammation (Flare)
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01023724.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01023724"
ct_last_update_post_date: 2011-08-26
last_seen_at: "2026-05-12T06:57:03.785Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# A Comparison of Post Phacoemulsification Aqueous Flare in Patients Using Ketorolac 0.45% 2 Times Daily (BID) and Bromfenac 0.09% 2 Times Daily (BID)

**Official Title:** A Comparison of Post Phacoemulsification Aqueous Flare in Patients Using Ketorolac 0.45% BID and Bromfenac 0.09% BID

**NCT ID:** [NCT01023724](https://clinicaltrials.gov/study/NCT01023724)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE4
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 50
- **Lead Sponsor:** Bucci Laser Vision Institute
- **Collaborators:** Allergan
- **Conditions:** Post Operative Anterior Chamber Inflammation (Flare)
- **Start Date:** 2009-12
- **Completion Date:** 2010-02
- **CT.gov Last Update:** 2011-08-26

## Brief Summary

Approximately 50 patients undergoing cataract surgery will be randomized in an even allocation (1:1) into two treatment groups, either ketorolac 0.45% BID or bromfenac 0.09% BID. Patients will be instructed to begin dosing study medication in the operative eye the day before surgery and continue dosing until day 14. KOWA flare measurements will be performed at postoperative day one and postoperative day 14. The amount of anterior chamber inflammation (flare) will be objectively measured.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
Inclusion Criteria:

* Subjects must be 18 years of age or older
* Scheduled for cataract surgery by phacoemulsification
* Subject must be willing to comply with all study requirements and be willing to give informed consent

Exclusion Criteria:

* Any subject that has a history of uveitis or active iritis
* Subject can have no previous intraocular surgery with the exception of refractive surgery. but not within 6 months
* No ocular use of prostaglandins within 2 weeks of surgery
* Use of oral, injectable or topical steroids,nonsteroidal anti-inflammatory drugs (NSAIDs) or immunosuppressants within 14 days prior to surgery
* Contraindications to NSAIDs
* Active ocular infection
```

## Arms

- **bromfenac 0.09%** (ACTIVE_COMPARATOR) — bromfenac 0.09% drops to be given pre operatively for one day BID, and then postoperatively for 14 days.
- **Acuvail** (ACTIVE_COMPARATOR) — Acuvail to be given preoperatively at BID for one day pre op and then post operatively for 14 days.

## Interventions

- **Ketorolac Tromethamine 0.45%** (DRUG) — Acuvail to be given 1 drop BID for one day prior to surgery and then 1 drop BID post operatively for 14 days.
- **Bromfenac 0.09%** (DRUG) — Drug given one drop BID for one day pre operatively and then BID for 14 days post operatively

## Primary Outcomes

- **Anterior Chamber Inflammation (Flare)** _(time frame: Day 14 of treatment)_ — Anterior chamber flare measured by assessing the number of inflammatory cells in the anterior chamber.

## Locations (1)

- Bucci Laser Vision Institute, Wilkes-Barre, Pennsylvania, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.bucci laser vision institute|wilkes-barre|pennsylvania|united states` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT01023724*  
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