Bacterial Conjunctivitis
Conditions
Keywords
Bacterial conjunctivitis, Anti-infective, Antibiotics
Brief summary
The purpose of this study is to evaluate Moxifloxacin 0.5% relative to Ofloxacin 0.3% in the treatment of bacterial conjunctivitis in Chinese patients.
Interventions
DRUGMoxifloxacin ophthalmic solution, 0.5%
DRUGOfloxacin ophthalmic solution, 0.3%
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Chinese. * Diagnosis of bacterial conjunctivitis based on clinical observation. * Understand and sign the approved informed consent. Legally authorized representative can provide informed consent for patients less than 18 years old and/or incapable of understanding the informed consent. * Willing to complete all required study procedures and visits. * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Women who are pregnant, lactating, or planning a pregnancy. * Only 1 sighted eye or vision not correctable to 0.6 logMAR or better in either eye. * Planned contact lens wear during the course of the study. * Signs and symptoms of bacterial conjunctivitis for longer than 4 days prior to Screening (Day 1). * Suspected fungal, viral, or Acanthamoeba infection. * Any systemic or ocular disease or disorder, complicating factor or structural abnormality that would negatively affect the conduct or outcome of the study. * History of recent surgery. * Presence of concomitant systemic viral infection. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Cure Rate | Day 9 | Ocular signs of bacterial conjunctivitis (bulbar conjunctival injection and conjunctival discharge/exudates) were rated by the investigator on a 4-point scale, with 0=normal/absent; 1=mild; 2=moderate, and 3=severe. Clinical cure rate is presented as the percentage of participants for which the sum of the numerical scores for the 2 cardinal ocular signs of bacterial conjunctivitis was 0 at Day 9 TOC/Exit Visit. |
| Microbiological Success Rate | Day 9 | Microbiological specimen(s) from the affected eye(s) were collected according to a protocol-defined process. Microbiological success rate is presented as the percentage of participants for which the pre-therapy pathogens at Visit 1 (Day 1) were eradicated at Day 9 TOC/Exit Visit. |
Countries
China
Participant flow
Recruitment details
Participants were recruited from 16 study centers located in China.
Pre-assignment details
Of the 985 enrolled, 3 participants were exited as screen failures prior to randomization. This reporting group includes all randomized participants (982).
Participants by arm
| Arm | Count |
|---|---|
| Moxifloxacin 1 drop instilled TID in each eye for 7 days with a TOC at Day 9 | 489 |
| Ofloxacin 1 drop instilled TID in each eye for 7 days with a TOC at Day 9 | 493 |
| Total | 982 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 4 | 4 |
| Overall Study | Lost to Follow-up | 2 | 1 |
| Overall Study | Patient decision unrelated to Advs Event | 11 | 11 |
| Overall Study | Protocol Violation | 3 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Moxifloxacin | Ofloxacin | Total |
|---|---|---|---|
| Age, Continuous | 37.4 years STANDARD_DEVIATION 15.54 | 38.4 years STANDARD_DEVIATION 15.83 | 37.9 years STANDARD_DEVIATION 15.69 |
| Sex: Female, Male Female | 254 Participants | 265 Participants | 519 Participants |
| Sex: Female, Male Male | 235 Participants | 228 Participants | 463 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 489 | 0 / 493 |
| serious Total, serious adverse events | 1 / 489 | 0 / 493 |
Outcome results
Primary
Clinical Cure Rate
Ocular signs of bacterial conjunctivitis (bulbar conjunctival injection and conjunctival discharge/exudates) were rated by the investigator on a 4-point scale, with 0=normal/absent; 1=mild; 2=moderate, and 3=severe. Clinical cure rate is presented as the percentage of participants for which the sum of the numerical scores for the 2 cardinal ocular signs of bacterial conjunctivitis was 0 at Day 9 TOC/Exit Visit.
Time frame: Day 9
Population: This analysis population includes all patients who received study medication, had no major protocol deviations, had bacteria present at Day 1 visit, and had baseline and TOC/exit data or early exit data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Moxifloxacin | Clinical Cure Rate | 85.4 percentage of participants |
| Ofloxacin | Clinical Cure Rate | 81.4 percentage of participants |
Primary
Microbiological Success Rate
Microbiological specimen(s) from the affected eye(s) were collected according to a protocol-defined process. Microbiological success rate is presented as the percentage of participants for which the pre-therapy pathogens at Visit 1 (Day 1) were eradicated at Day 9 TOC/Exit Visit.
Time frame: Day 9
Population: This analysis population includes all patients who received study medication, had no major protocol deviations, had bacteria present at Day 1 visit, and had baseline and TOC/exit data or early exit data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Moxifloxacin | Microbiological Success Rate | 95.3 percentage of participants |
| Ofloxacin | Microbiological Success Rate | 94.8 percentage of participants |