Cataract
Conditions
Keywords
Cataract
Brief summary
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.
Interventions
DRUGVigadexa (moxifloxacin 0.5% and dexamethasone 0.1%) eye drops
1 drop every 6 hours into the study eye
Sponsors
Alcon Research
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ≧18 years of age * able to sign an informed consent and complete all required visits * intends to have a cataract extraction surgery followed by implantation of a posterior chamber Intraocular lens (IOL) * Intraocular Pressure (IOP) ≦ 20 millimeters mercury (mmHg)
Exclusion criteria
* Uncontrolled glaucoma or IOP * use of ocular anti-infectious during the study and within 30 days prior to the enrollment, secondary implantation or replacement of IOL in the study eye * use of steroid during the study or within 14 days prior to enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Percentage of Patients With a Score of Zero for Anterior Chamber Cells. | 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 |
| The Percentage of Patients With no Ocular Pain | Day 15 after cataract surgery | — |
Countries
United States
Participant flow
Recruitment details
64 patients were enrolled into the study
Pre-assignment details
Nonrandomized
Participants by arm
| Arm | Count |
|---|---|
| Vigadexa Group Vigadexa (moxifloxacin 0.5% and dexamethasone 0.1%) eye drops; 1 drop every 6 hours into the study eye | 64 |
| Total | 64 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Physician Decision | 2 |
Baseline characteristics
| Characteristic | Vigadexa Group |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 43 Participants |
| Age, Categorical Between 18 and 65 years | 21 Participants |
| Sex: Female, Male Female | 37 Participants |
| Sex: Female, Male Male | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 64 |
| serious Total, serious adverse events | 0 / 64 |
Outcome results
Primary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vigadexa Group | The Percentage of Patients With a Score of Zero for Anterior Chamber Cells. | 91.7 Percentage of participants |
Primary
The Percentage of Patients With no Ocular Pain
Time frame: Day 15 after cataract surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vigadexa Group | The Percentage of Patients With no Ocular Pain | 96.7 Percentage of participants |