COMPLETEDResults postedPhase 3

Efficacy and Safety of Bromfenac Ophthalmic Solution in Cataract Surgery

Sponsor

Bausch & Lomb Incorporated

Enrollment

126 participants

Sites

1 locations

Start Date

June 2008

Completion

November 2008

Cataractbromfenac ophthalmic solutionplacebo

Enrollment & Timeline

Completed

Target N

126

participants

Sites

locations

Duration

5 months

total trial span

Rate

pts/month needed

At 1 sites, each site needs to enroll approximately 25.0 patients/month to hit the enrollment target on schedule.

View on ClinicalTrials.gov

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Primary Outcomes

Number of Participants With Summed Ocular Inflammation Score (SOIS) of Zero

Day 15

Participants with SOIS of 0. Scale: 0=0 cells (complete absence); 0.5=1-5 cells (trace); 1=6-15 cells (very slight); 2=16-25 cells (moderate); 3=26-50 cells (marked); 4=\>50 cells (intense)

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Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

No linked publications found in PubMed

PubMed/NCBI (daily updates) FDA FAERS (quarterly updates) WHO ICTRP (weekly updates)

Ask AI

Fetching protocol from ClinicalTrials.gov…

COMPLETEDResults postedPhase 3

Efficacy and Safety of Bromfenac Ophthalmic Solution in Cataract Surgery

Sponsor

Bausch & Lomb Incorporated

Enrollment

126 participants

Sites

1 locations

Start Date

June 2008

Completion

November 2008

Cataractbromfenac ophthalmic solutionplacebo

Enrollment & Timeline

Completed

Target N

126

participants

Sites

locations

Duration

5 months

total trial span

Rate

pts/month needed

At 1 sites, each site needs to enroll approximately 25.0 patients/month to hit the enrollment target on schedule.

View on ClinicalTrials.gov

Ask AI

Primary Outcomes

Number of Participants With Summed Ocular Inflammation Score (SOIS) of Zero

Day 15

Participants with SOIS of 0. Scale: 0=0 cells (complete absence); 0.5=1-5 cells (trace); 1=6-15 cells (very slight); 2=16-25 cells (moderate); 3=26-50 cells (marked); 4=\>50 cells (intense)

Ask AI

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

No linked publications found in PubMed

PubMed/NCBI (daily updates) FDA FAERS (quarterly updates) WHO ICTRP (weekly updates)

Ask AI

Eligibility

Min Age

18 Years

Sex

all

Healthy Volunteers

View full criteria

Inclusion Criteria:

* Scheduled for cataract surgery

Exclusion Criteria:

* Known hypersensitivity to bromfenac and salicylates

Efficacy and Safety of Bromfenac Ophthalmic Solution in Cataract Surgery

Enrollment & Timeline

Primary Outcomes

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

Efficacy and Safety of Bromfenac Ophthalmic Solution in Cataract Surgery

Enrollment & Timeline

Primary Outcomes

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

Eligibility

Trial Sites (1)