Trial Outcomes & Findings for Moxifloxacin vs. Polytrim for Conjunctivitis (NCT NCT00581542)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

124 participants

Primary outcome timeframe

10 days

Results posted on

2016-01-18

Participant Flow

Participant milestones

Participant milestones
Measure	Polytrim Group Randomization to polytrim : 1-2 drops four times a day for 8-10 days.	Moxifloxin Group Randomization to topical moxifloxacin 1-2 drops 3x/day for 8-10 days
Overall Study STARTED	62	62
Overall Study COMPLETED	51	39
Overall Study NOT COMPLETED	11	23

Reasons for withdrawal

Reasons for withdrawal
Measure	Polytrim Group Randomization to polytrim : 1-2 drops four times a day for 8-10 days.	Moxifloxin Group Randomization to topical moxifloxacin 1-2 drops 3x/day for 8-10 days
Overall Study they met an exclusion criteria	2	2
Overall Study Lost to Follow-up	9	21

Baseline Characteristics

Moxifloxacin vs. Polytrim for Conjunctivitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Polytrim Ophthalmic Solution n=62 Participants randomization to topical polytrim	Moxifloxacin Ophthalmic Solution n=62 Participants randomization to topical moxifloxacin	Total n=124 Participants Total of all reporting groups
Age, Continuous	73.4 months STANDARD_DEVIATION 50 • n=5 Participants	70.3 months STANDARD_DEVIATION 48 • n=7 Participants	71.3 months STANDARD_DEVIATION 49 • n=5 Participants
Sex: Female, Male Female	39 Participants n=5 Participants	28 Participants n=7 Participants	67 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants	34 Participants n=7 Participants	57 Participants n=5 Participants
Region of Enrollment United States	62 participants n=5 Participants	62 participants n=7 Participants	124 participants n=5 Participants

PRIMARY outcome

Timeframe: 10 days

Outcome measures

Outcome measures
Measure	Polytrim Arm n=51 Participants	Moxifloxacin n=39 Participants
Number of Participants With Normal Physical Examination of the Eye	49 participants	37 participants

SECONDARY outcome

Timeframe: 10 days

Population: Only participants who were culture positive at baseline were tested at day 10. 20 participants were negative at baseline in the polytrim group and 11 participants were negative in the moxifloxin group.

Conjunctival swab specimens were inoculated onto tryptic soy agar with 5% sheep blood and GC II agar supplemented with hemoglobin and isovialex with incubation at 35 degrees C in ambient air supplemented with 5% carbon dioxide for 48 hours. S pneumoniae, H influenzai and M Catarrhalis were identified.

Outcome measures

Outcome measures
Measure	Polytrim Arm n=28 Participants	Moxifloxacin n=31 Participants
Number of Participants With a Negative Bacterial Culture	22 participants	19 participants

Adverse Events

Moxifloxacin Treatment Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Polytrim Treatment Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Franci Gigilotti

University of Rochester, Strong Mem orial Hospital

Phone: 585 275-0588

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place