Bacterial Conjunctivitis
Conditions
Keywords
pink eye, conjunctivitis, moxifloxacin, fluoroquinolone
Brief summary
The purpose of this study is to evaluate the safety and efficacy of Moxifloxacin AF Ophthalmic Solution compared to Moxifloxacin AF Vehicle in the treatment of bacterial conjunctivitis in patients one month of age or older.
Interventions
DRUGMoxifloxacin Alternative Formulation (AF) Ophthalmic Solution 0.5%
Eye drops
OTHERMoxifloxacin AF Vehicle
Inactive ingredients used as a placebo for masking purposes
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Months to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosed with bacterial conjunctivitis in 1 or both eyes; * Able to understand and sign an informed consent form. If subject is \<18 years of age, the informed consent must be understood and signed by the subject's legally authorized representative; * Agrees to comply with the visit schedule and other requirements of the study; * Other protocol-specified inclusion criteria may apply.
Exclusion criteria
* Signs and symptoms of bacterial conjunctivitis for longer than 4 days prior to Day 1; * Presence of concomitant viral infection; * Infants with ophthalmia neonatorum of gonococcal, Chlamydia, herpetic or chemical origin; * Infants whose birth mothers had any sexually transmitted disease within 1 month prior to delivery; * Infants undergoing treatment for retinopathy of prematurity; * Contact lens wear during the course of the study; * Only 1 sighted eye or vision in either eye not correctable to 0.6 logMAR units (20/80) or better; * Use of medications, as specified in the protocol; * Any systemic or ocular disease or disorder, complicating factors or structural abnormality that could negatively affect the conduct or outcome of the study; * Known or suspected allergy or hypersensitivity to fluoroquinolones; * Pregnant, lactating, or of childbearing potential and not using adequate birth control to prevent pregnancy; * Other protocol-specified
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Cure at the Day 4 (EOT)/Exit Visit | Day 4 | Clinical cure was attained if the sum of the 2 cardinal ocular signs of bacterial conjunctivitis (bulbar conjunctival injection and conjunctival discharge/exudate) was zero (ie, normal or absent) 12-48 hours after the last dose. Clinical cure was reported as a percentage. Only one eye (study eye) contributed to the analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Microbiological Success at the Day 4 (EOT)/Exit Visit | Day 4 | Microbiological success was attained if the pre-therapy bacterial pathogens were eradicated 12-48 hours after the last dose. Microbiological success is reported as a percentage. Only one eye (study eye) contributed to the analysis. |
Participant flow
Recruitment details
Subjects were recruited from 108 study centers located in the US.
Pre-assignment details
1179 subjects with bacterial conjunctivitis were randomized and treated to Moxifloxacin AF or Moxifloxacin AF vehicle.
Participants by arm
| Arm | Count |
|---|---|
| Moxifloxacin AF Moxifloxacin AF Ophthalmic Solution 0.5%, 1 drop in each eye twice daily for 3 days | 593 |
| Vehicle Moxifloxacin AF Vehicle, 1 drop in each eye twice daily for 3 days | 586 |
| Total | 1,179 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 6 |
| Overall Study | Lost to Follow-up | 3 | 9 |
| Overall Study | Reason not given | 1 | 0 |
| Overall Study | Treatment Failure | 6 | 10 |
| Overall Study | Withdrawal by Subject | 3 | 7 |
Baseline characteristics
| Characteristic | Moxifloxacin AF | Vehicle | Total |
|---|---|---|---|
| Age, Customized 85 years and over | 4 Participants | 5 Participants | 9 Participants |
| Age, Customized Adolescents (12-17 years) | 71 Participants | 72 Participants | 143 Participants |
| Age, Customized Adults (18-64 years) | 257 Participants | 230 Participants | 487 Participants |
| Age, Customized Children (2-11 years) | 174 Participants | 184 Participants | 358 Participants |
| Age, Customized From 65-84 years | 38 Participants | 48 Participants | 86 Participants |
| Age, Customized Infants and toddlers (28 days-23 months) | 49 Participants | 47 Participants | 96 Participants |
| Sex: Female, Male Female | 353 Participants | 338 Participants | 691 Participants |
| Sex: Female, Male Male | 240 Participants | 248 Participants | 488 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 593 | 0 / 586 |
| other Total, other adverse events | 0 / 593 | 0 / 586 |
| serious Total, serious adverse events | 0 / 593 | 0 / 586 |
Outcome results
Primary
Clinical Cure at the Day 4 (EOT)/Exit Visit
Clinical cure was attained if the sum of the 2 cardinal ocular signs of bacterial conjunctivitis (bulbar conjunctival injection and conjunctival discharge/exudate) was zero (ie, normal or absent) 12-48 hours after the last dose. Clinical cure was reported as a percentage. Only one eye (study eye) contributed to the analysis.
Time frame: Day 4
Population: This analysis population includes all patients who received drug, had at least 1 on-therapy visit and were pathogen positive for bacteria on Day 1 (Microbiological Intent-to-Treat (MBITT) Analysis Set).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Moxifloxacin AF | Clinical Cure at the Day 4 (EOT)/Exit Visit | 62.5 percentage of subjects |
| Vehicle | Clinical Cure at the Day 4 (EOT)/Exit Visit | 50.6 percentage of subjects |
Secondary
Microbiological Success at the Day 4 (EOT)/Exit Visit
Microbiological success was attained if the pre-therapy bacterial pathogens were eradicated 12-48 hours after the last dose. Microbiological success is reported as a percentage. Only one eye (study eye) contributed to the analysis.
Time frame: Day 4
Population: MBITT Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Moxifloxacin AF | Microbiological Success at the Day 4 (EOT)/Exit Visit | 74.5 percentage of subjects |
| Vehicle | Microbiological Success at the Day 4 (EOT)/Exit Visit | 56 percentage of subjects |