A Phase 4 interventional study of Vigadexa (moxifloxacin 0.5% and dexamethasone 0.1%) eye drops in Cataract, sponsored by Alcon Research. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-03-09.
Sponsored by Alcon Research · Phase 4, Interventional, and Treatment
To demonstrate that the combination formulation of Moxifloxacin/Dexamethasone Eye Drop is effective and safe for the prevention of postoperative inflammation as a consequence of cataract extraction surgery.
1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.
This study's enrollment of 64 is below the median of 80 across 1,155 interventional studies indexed under Cataract.
Browse Cataract studies →Alcon Research is the lead sponsor of 608 studies on the registry; 9 are open to participants now.
Of its 109 completed or terminated interventional studies of FDA-regulated products, 99 (91%) have results posted.
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Exclusion Criteria:
Vigadexa (moxifloxacin 0.5% and dexamethasone 0.1%) eye drops
Drug: 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.
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
Time frame: Day 15 after cataract surgery
The Percentage of Patients With no Ocular Pain
Time frame: Day 15 after cataract surgery
64 patients were enrolled into the study
| Milestone | Vigadexa Group |
|---|---|
| Started | 64 |
| Completed | 60 |
| Not completed | 4 |
| Withdrew: Physician decision | 2 |
| Withdrew: Lost to follow-up | 2 |
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
| Percentage of participants | Vigadexa Group |
|---|---|
| The Percentage of Patients With a Score of Zero for Anterior Chamber Cells. | 91.7 |
| Percentage of participants | Vigadexa Group |
|---|---|
| The Percentage of Patients With no Ocular Pain | 96.7 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Vigadexa Group | — | 0/64 (0%) | 0/64 (0%) |
| Age, Categorical(Participants) | Vigadexa Group |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 21 |
| >=65 years | 43 |
| Sex: Female, Male(Participants) | Vigadexa Group |
|---|---|
| Female | 37 |
| Male | 27 |
This study is completed, as verified in Mar 2010. You cannot join it, but the record below documents what was studied.
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Alcon Research