Bacterial Conjunctivitis
Conditions
Brief summary
This is a 7 day study to evaluate the safety and efficacy of topical gatifloxacin ophthalmic solution for the treatment of bacterial conjunctivitis in subjects from birth to 31 days of age
Interventions
DRUGgatifloxacin
Day 1-6 = 1 drop of study medication three times a day
DRUGmoxifloxacin 0.5% eye drops
Day 1-6 = 1 drop of study medication three times a day
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 31 Days
Healthy volunteers
No
Inclusion criteria
* diagnosed with bacterial conjunctivitis
Exclusion criteria
* chemical or foreign body trauma to either eye * infection in either eye (besides bacterial conjunctivitis) * white spots in the cornea or ulcers in either eye * clinical diagnosis of chlamydia or gonorrhea in either eye
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With Clearing (Clinical Success) of Conjunctival Erythema and Conjunctival Discharge at Day 7 | Day 7 | Percentage of patients that achieved clinical success, defined as a score of 0 for both conjunctival erythema and conjunctival discharge at Day 7. Conjunctival erythema and conjunctival discharge were each assessed on a 4-point severity grade scale (0=none, +1=mild, +2=moderate, +3=severe). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With Microbiological Improvement | Day 7 | Percentage of patients with microbiological improvement, defined such that all bacteria present above threshold at Day 1 (Baseline) are eradicated (absent) or reduced at Day 7 based on a Classification of Microbial Response (Eradication=pathogen is absent in follow-up culture; Reduction=pathogen is reduced from baseline below threshold count in follow-up culture; Persistence=pathogen reduced from baseline but is above or equal to threshold count in follow-up culture; and Proliferation=pathogen has increased in count from baseline in follow-up culture). |
| Percentage of Patients With Improvement in Ocular Signs for Lid Erythema | Days 7 | Percentage of patients with at least a 1-grade improvement in ocular signs for lid erythema at Day 7 from Day 1 (Baseline). Lid erythema was assessed on a 4-point severity grade scale (0=none, +1=mild, +2=moderate, +3=severe). |
| Percentage of Patients With Improvement in Ocular Signs for Conjunctival Discharge at Day 7 | Day 7 | Percentage of patients with at least a 1-grade improvement in ocular signs for conjunctival discharge at Day 7 from Day 1 (Baseline). Conjunctival discharge was assessed on a 4-point severity grade scale (0=none, +1=mild, +2=moderate, +3=severe). |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Gatifloxacin 0.3% | 85 |
| Moxifloxacin 0.5% | 86 |
| Total | 171 |
Baseline characteristics
| Characteristic | Gatifloxacin 0.3% | Moxifloxacin 0.5% | Total |
|---|---|---|---|
| Age Continuous | 15.2 days STANDARD_DEVIATION 6.59 | 15.2 days STANDARD_DEVIATION 6.05 | 15.2 days STANDARD_DEVIATION 6.31 |
| Sex: Female, Male Female | 37 Participants | 22 Participants | 59 Participants |
| Sex: Female, Male Male | 48 Participants | 64 Participants | 112 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 11 / 84 | 8 / 86 |
| serious Total, serious adverse events | 0 / 84 | 1 / 86 |
Outcome results
Primary
Percentage of Patients With Clearing (Clinical Success) of Conjunctival Erythema and Conjunctival Discharge at Day 7
Percentage of patients that achieved clinical success, defined as a score of 0 for both conjunctival erythema and conjunctival discharge at Day 7. Conjunctival erythema and conjunctival discharge were each assessed on a 4-point severity grade scale (0=none, +1=mild, +2=moderate, +3=severe).
Time frame: Day 7
Population: Modified Intent to Treat; defined as all randomized patients who were culture positive at baseline meaning the culture of the eye grew bacteria.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gatifloxacin 0.3% | Percentage of Patients With Clearing (Clinical Success) of Conjunctival Erythema and Conjunctival Discharge at Day 7 | 78.6 Percentage of Patients |
| Moxifloxacin 0.5% | Percentage of Patients With Clearing (Clinical Success) of Conjunctival Erythema and Conjunctival Discharge at Day 7 | 84.4 Percentage of Patients |
Secondary
Percentage of Patients With Improvement in Ocular Signs for Conjunctival Discharge at Day 7
Percentage of patients with at least a 1-grade improvement in ocular signs for conjunctival discharge at Day 7 from Day 1 (Baseline). Conjunctival discharge was assessed on a 4-point severity grade scale (0=none, +1=mild, +2=moderate, +3=severe).
Time frame: Day 7
Population: Modified Intent to Treat; defined as all randomized patients who were culture positive at baseline meaning the culture of the eye grew bacteria
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gatifloxacin 0.3% | Percentage of Patients With Improvement in Ocular Signs for Conjunctival Discharge at Day 7 | 94.6 Percentage of Patients |
| Moxifloxacin 0.5% | Percentage of Patients With Improvement in Ocular Signs for Conjunctival Discharge at Day 7 | 92.2 Percentage of Patients |
Secondary
Percentage of Patients With Improvement in Ocular Signs for Lid Erythema
Percentage of patients with at least a 1-grade improvement in ocular signs for lid erythema at Day 7 from Day 1 (Baseline). Lid erythema was assessed on a 4-point severity grade scale (0=none, +1=mild, +2=moderate, +3=severe).
Time frame: Days 7
Population: Modified Intent to Treat; defined as all randomized patients who were culture positive at baseline meaning the culture of the eye grew bacteria
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gatifloxacin 0.3% | Percentage of Patients With Improvement in Ocular Signs for Lid Erythema | 76.8 Percentage of Patients |
| Moxifloxacin 0.5% | Percentage of Patients With Improvement in Ocular Signs for Lid Erythema | 75.0 Percentage of Patients |
Secondary
Percentage of Patients With Microbiological Improvement
Percentage of patients with microbiological improvement, defined such that all bacteria present above threshold at Day 1 (Baseline) are eradicated (absent) or reduced at Day 7 based on a Classification of Microbial Response (Eradication=pathogen is absent in follow-up culture; Reduction=pathogen is reduced from baseline below threshold count in follow-up culture; Persistence=pathogen reduced from baseline but is above or equal to threshold count in follow-up culture; and Proliferation=pathogen has increased in count from baseline in follow-up culture).
Time frame: Day 7
Population: Modified Intent to Treat; defined as all randomized patients who were culture positive at baseline meaning the culture of the eye grew bacteria
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gatifloxacin 0.3% | Percentage of Patients With Microbiological Improvement | 94.6 Percentage of Patients |
| Moxifloxacin 0.5% | Percentage of Patients With Microbiological Improvement | 92.2 Percentage of Patients |