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COMPLETED Phase 4

Determination of Optimum Duration of Treatment With Bromfenac (Xibrom) Eyedrops Following Cataract Surgery

NCT00758199 · View on ClinicalTrials.gov ↗

Study Summary

The objective of this study is to determine if an extension of bromfenac BID monotherapy is effective in the decreasing retinal thickening post cataract IOL placement surgery. No studies exist on how long to treat with an NSAID post cataract IOL placement surgery. Currently, NSAID therapy post IOL placement surgery is in conjunction with steroid treatment, lasting approximately 3 weeks. This study is designed to examine if there is benefit to extending NSAID monotherapy in regards to macular thickening and the incidence of CME.

Conditions Studied

Interventions

  • DRUG Bromfenac
  • DRUG Prednisolone Acetate
  • DRUG Moxifloxacin hydrochloride

Study Locations (1)

California

  • Altos Eye Physicians — Los Altos

Trial Details

FieldValue
Enrollment Target 49 participants
Start Date 2008-07
Est. Completion 2010-01
Phase Phase 4

Sponsor

Bp Consulting

4 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00758199

The ClinicalTrials.gov registry entry for NCT00758199 describes a study currently listed as completed. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 49 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bp Consulting, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Cataracts appearing as the primary indexed condition, and to 3 interventions — of which Bromfenac is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00758199 reports 1 study location spanning 1 distinct geographic area — top geographies include California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT00758199 about?

NCT00758199 is a clinical study titled "Determination of Optimum Duration of Treatment With Bromfenac (Xibrom) Eyedrops Following Cataract Surgery". The objective of this study is to determine if an extension of bromfenac BID monotherapy is effective in the decreasing retinal thickening post cataract IOL placement surgery. No studies exist on how long to treat with an NSAID post cataract IOL placement surgery. Currently, NSAID therapy post IOL p...

What is the current status of trial NCT00758199?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 49 participants. The study started on 2008-07. Estimated completion is 2010-01.

What conditions does trial NCT00758199 study?

This clinical trial studies the following conditions: Cataracts. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00758199?

The interventions under investigation include: Bromfenac (DRUG), Prednisolone Acetate (DRUG), Moxifloxacin hydrochloride (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00758199?

This trial is sponsored by Bp Consulting, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00758199 being conducted?

This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial