A Study of the Safety and Efficacy of Gatifloxacin in Patients With Bacterial Conjunctivitis

Percentage of patients that achieved clinical success, defined as achievement of a score of zero for both conjunctival hyperemia and conjunctival discharge in the study eye at Day 6. Conjunctival hyperemia and conjunctival discharge were each assessed on a 4-point severity grade scale (0=none, +1=mild, +2=moderate, +3=severe).

Time frame: Day 6

Population: Modified Intent to Treat; defined as all randomized patients who were culture positive at baseline meaning the culture of the eye grew bacteria. (Note: The Day 6 analysis included all Day 6 visit data, regardless of whether it was collected on Day 6 or on a later day).

Percentage of patients with clinical improvement of ocular signs at Day 6 based on a 4-point scale (0 = none, 1 = mild, 2 = moderate, and 3 = severe), defined as a decrease (improvement) from Day 1 (Baseline) in the total score of conjunctival hyperemia and mucopurulent discharge (pus),with no increase (worsening) from Day 1 (Baseline) in either individual variable in the study eye.

Time frame: Day 6

Population: Modified Intent to Treat; defined as all randomized patients who were culture positive at baseline meaning the culture of the eye grew bacteria. (Note: The Day 6 analysis included all Day 6 visit data, regardless of whether it was collected on Day 6 or on a later day).

Percentage of patients with clinical improvement of ocular symptoms at Day 6, defined as a decrease (improvement) from Day 1 (Baseline) in the total score of itching and tearing (each on 4-point scale: 0 = none, 1 = mild, 2 = moderate, and 3 = severe), with no increase (worsening) from Day 1 (Baseline) in any individual score in the study eye diagnosed with bacterial conjunctivitis

Time frame: Day 6

Population: Modified Intent to Treat; defined as all randomized patients who were culture positive at baseline meaning the culture of the eye grew bacteria. (Note: The Day 6 analysis included all Day 6 visit data, regardless of whether it was collected on Day 6 or on a later day).

Percentage of patients with microbiological cure, defined such that all bacteria present in the study eye at Day 1 (Baseline) are eradicated (or absent) at Day 6 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 6

Population: Modified Intent to Treat; defined as all randomized patients who were culture positive at baseline meaning the culture of the eye grew bacteria. (Note: The Day 6 analysis included all Day 6 visit data, regardless of whether it was collected on Day 6 or on a later day).

Percentage of patients that achieved clinical success, defined as achievement of a score of zero for both conjunctival hyperemia and conjunctival discharge in the study eye up to Day 6. Conjunctival hyperemia and conjunctival discharge were each assessed on a 4-point severity grade scale (0=none, +1=mild, +2=moderate, +3=severe). (Note: The Up to Day 6 analysis included all data up to the Day 6 time point but excluded any Day 6 visit data that was collected after the Day 6 time point).

Time frame: 6 Days

Population: Modified Intent to Treat; defined as all randomized patients who were culture positive at baseline meaning the culture of the eye grew bacteria. (Note: The Up to Day 6 analysis included all data up to the Day 6 time point but excluded any Day 6 visit data that was collected after the Day 6 time point).