A Phase 3 interventional study of Moxifloxacin Alternative Formulation (AF) Ophthalmic Solution 0.5% and Moxifloxacin AF Vehicle in Bacterial Conjunctivitis, sponsored by Alcon Research. Completed. Open to participants aged 1 Month and older. Per ClinicalTrials.gov, last updated 2018-01-02.
Sponsored by Alcon Research (part of Alcon) · Phase 3, Interventional, and Treatment
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.
40 studies on the registry are indexed under Conjunctivitis, Bacterial; 2 are open to participants now.
This study's enrollment of 1,179 is above the median of 261 across 36 interventional studies indexed under Conjunctivitis, Bacterial.
Browse Conjunctivitis, Bacterial studies →Alcon Research is the lead sponsor of 624 studies on the registry; 9 are open to participants now.
Of its 112 completed or terminated interventional studies of FDA-regulated products, 102 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Moxifloxacin Alternative Formulation (AF) Ophthalmic Solution 0.5%, 1 drop in each eye twice daily for 3 days
Drug: Moxifloxacin Alternative Formulation (AF) Ophthalmic Solution 0.5%
Moxifloxacin AF vehicle, 1 drop in each eye twice daily for 3 days
Other: Moxifloxacin AF Vehicle
Eye drops
Inactive ingredients used as a placebo for masking purposes
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
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
Subjects were recruited from 108 study centers located in the US.
| Milestone | Moxifloxacin AF | Vehicle |
|---|---|---|
| Started | 593 | 586 |
| Completed | 579 | 554 |
| Not completed | 14 | 32 |
| Withdrew: Adverse event | 1 | 6 |
| Withdrew: Withdrawal by subject | 3 | 7 |
| Withdrew: Lost to follow-up | 3 | 9 |
| Withdrew: Treatment failure | 6 | 10 |
| Withdrew: Reason not given | 1 | 0 |
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.
| percentage of subjects | Moxifloxacin AF | Vehicle |
|---|---|---|
| Clinical Cure at the Day 4 (EOT)/Exit Visit | 62.5 | 50.6 |
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.
| percentage of subjects | Moxifloxacin AF | Vehicle |
|---|---|---|
| Microbiological Success at the Day 4 (EOT)/Exit Visit | 74.5 | 56 |
Collected over Baseline through study completion, an average of 4 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Moxifloxacin AF | 0/593 (0%) | 0/593 (0%) | 0/593 (0%) |
| Vehicle | 0/586 (0%) | 0/586 (0%) | 0/586 (0%) |
This population analysis includes all subjects who received study drug (Safety Analysis Set).
| Age, Customized(Participants) | Moxifloxacin AF | Vehicle | Total |
|---|---|---|---|
| Infants and toddlers (28 days-23 months) | 49 | 47 | 96 |
| Children (2-11 years) | 174 | 184 | 358 |
| Adolescents (12-17 years) | 71 | 72 | 143 |
| Adults (18-64 years) | 257 | 230 | 487 |
| From 65-84 years | 38 | 48 | 86 |
| 85 years and over | 4 | 5 | 9 |
| Sex: Female, Male(Participants) | Moxifloxacin AF | Vehicle | Total |
|---|---|---|---|
| Female | 353 | 338 | 691 |
| Male | 240 | 248 | 488 |
No study locations are listed for this record.
Ran from Oct 2008 to primary completion in Mar 2010, 17 months.
Results were first posted in Mar 2011, 1 year after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
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