Trial Outcomes & Findings for Study of Efficacy and Safety of Vigadexa in Treating Inflammation and Infection Post-cataract Surgery (NCT NCT00870103)

Results Overview

The percentage of patients with a score of zero for Anterior chamber cells. Anterior chamber inflammation was evaluated based on the number of cells per high-power field measured using the narrowest slit beam of the lamp (0.5 at a height of 8mm). Anterior chamber cells was recorded on a 0-4 point scale,0 = Less than 5 cells; 1 = Mild: 5-10 cells; 2 = Moderate:11-20 cells; 3 = Marked: 21-50 cells; 4 = Severe: Greater than 50 cells / hypopyon

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

64 participants

Primary outcome timeframe

Day 15 after cataract surgery

Results posted on

2010-03-09

Participant Flow

64 patients were enrolled into the study

Nonrandomized

Participant milestones

Participant milestones
Measure	Vigadexa Group Vigadexa (moxifloxacin 0.5% and dexamethasone 0.1%) eye drops; 1 drop every 6 hours into the study eye
Overall Study STARTED	64
Overall Study COMPLETED	60
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Vigadexa Group Vigadexa (moxifloxacin 0.5% and dexamethasone 0.1%) eye drops; 1 drop every 6 hours into the study eye
Overall Study Physician Decision	2
Overall Study Lost to Follow-up	2

Baseline Characteristics

Study of Efficacy and Safety of Vigadexa in Treating Inflammation and Infection Post-cataract Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vigadexa Group n=64 Participants Vigadexa (moxifloxacin 0.5% and dexamethasone 0.1%) eye drops; 1 drop every 6 hours into the study eye
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	21 Participants n=5 Participants
Age, Categorical >=65 years	43 Participants n=5 Participants
Sex: Female, Male Female	37 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 15 after cataract surgery

The percentage of patients with a score of zero for Anterior chamber cells. Anterior chamber inflammation was evaluated based on the number of cells per high-power field measured using the narrowest slit beam of the lamp (0.5 at a height of 8mm). Anterior chamber cells was recorded on a 0-4 point scale,0 = Less than 5 cells; 1 = Mild: 5-10 cells; 2 = Moderate:11-20 cells; 3 = Marked: 21-50 cells; 4 = Severe: Greater than 50 cells / hypopyon

Outcome measures

Outcome measures
Measure	Vigadexa Group n=60 Participants Vigadexa (moxifloxacin 0.5% and dexamethasone 0.1%) eye drops; 1 drop every 6 hours into the study eye
The Percentage of Patients With a Score of Zero for Anterior Chamber Cells.	91.7 Percentage of participants

PRIMARY outcome

Timeframe: Day 15 after cataract surgery

Outcome measures

Outcome measures
Measure	Vigadexa Group n=60 Participants Vigadexa (moxifloxacin 0.5% and dexamethasone 0.1%) eye drops; 1 drop every 6 hours into the study eye
The Percentage of Patients With no Ocular Pain	96.7 Percentage of participants

Adverse Events

Vigadexa Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Alcon Clinical

Alcon Research Ltd

Phone: 888.451.3937; 817.568.6725

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place