A Phase 3 interventional study of Moxifloxacin ophthalmic solution, 0.5% and Ofloxacin ophthalmic solution, 0.3% in Bacterial Conjunctivitis, sponsored by Alcon Research. Completed at 1 site in China. Open to participants aged 1 Year and older. Per ClinicalTrials.gov, last updated 2015-05-12.
Sponsored by Alcon Research (part of Alcon) · Phase 3, Interventional, and Treatment
The purpose of this study is to evaluate Moxifloxacin 0.5% relative to Ofloxacin 0.3% in the treatment of bacterial conjunctivitis in Chinese patients.
40 studies on the registry are indexed under Conjunctivitis, Bacterial; 2 are open to participants now.
This study's enrollment of 985 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.
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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.
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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.
Moxifloxacin ophthalmic solution, 0.5%, 1 drop instilled 3 times per day (TID) in each eye for 7 days with a test-of-cure (TOC) at Day 9
Drug: Moxifloxacin ophthalmic solution, 0.5%
Ofloxacin ophthalmic solution, 0.3%, 1 drop instilled 3 times per day (TID) in each eye for 7 days with a test-of-cure (TOC) at Day 9
Drug: Ofloxacin ophthalmic solution, 0.3%
Also known as: VIGAMOX®
Also known as: Tarivid® Eye Drops
Clinical Cure Rate
Ocular signs of bacterial conjunctivitis (bulbar conjunctival injection and conjunctival discharge/exudates) were rated by the investigator on a 4-point scale, with 0=normal/absent; 1=mild; 2=moderate, and 3=severe. Clinical cure rate is presented as the percentage of participants for which the sum of the numerical scores for the 2 cardinal ocular signs of bacterial conjunctivitis was 0 at Day 9 TOC/Exit Visit.
Time frame: Day 9
Microbiological Success Rate
Microbiological specimen(s) from the affected eye(s) were collected according to a protocol-defined process. Microbiological success rate is presented as the percentage of participants for which the pre-therapy pathogens at Visit 1 (Day 1) were eradicated at Day 9 TOC/Exit Visit.
Time frame: Day 9
Participants were recruited from 16 study centers located in China.
| Milestone | Moxifloxacin | Ofloxacin |
|---|---|---|
| Started | 489 | 493 |
| Completed | 469 | 476 |
| Not completed | 20 | 17 |
| Withdrew: Adverse event | 4 | 4 |
| Withdrew: Lost to follow-up | 2 | 1 |
| Withdrew: Withdrawal by subject | 0 | 1 |
| Withdrew: Protocol violation | 3 | 0 |
| Withdrew: Patient decision unrelated to advs event | 11 | 11 |
Ocular signs of bacterial conjunctivitis (bulbar conjunctival injection and conjunctival discharge/exudates) were rated by the investigator on a 4-point scale, with 0=normal/absent; 1=mild; 2=moderate, and 3=severe. Clinical cure rate is presented as the percentage of participants for which the sum of the numerical scores for the 2 cardinal ocular signs of bacterial conjunctivitis was 0 at Day 9 TOC/Exit Visit.
| percentage of participants | Moxifloxacin | Ofloxacin |
|---|---|---|
| Clinical Cure Rate | 85.4 | 81.4 |
Microbiological specimen(s) from the affected eye(s) were collected according to a protocol-defined process. Microbiological success rate is presented as the percentage of participants for which the pre-therapy pathogens at Visit 1 (Day 1) were eradicated at Day 9 TOC/Exit Visit.
| percentage of participants | Moxifloxacin | Ofloxacin |
|---|---|---|
| Microbiological Success Rate | 95.3 | 94.8 |
Collected over Adverse events (AEs) were collected for the duration of the study (May 2012 to April 2014). This analysis group includes all patients who were administered or potentially used study medication.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Moxifloxacin | — | 1/489 (0.2%) | 0/489 (0%) |
| Ofloxacin | — | 0/493 (0%) | 0/493 (0%) |
| Event | Moxifloxacin | Ofloxacin |
|---|---|---|
| HypertensionVascular disorders | 1/489 | 0/493 |
This analysis population includes all participants who were administered study medication or potentially used study medication.
| Age, Continuous(years) | Moxifloxacin | Ofloxacin | Total |
|---|---|---|---|
| Mean | 37.4 ± 15.54 | 38.4 ± 15.83 | 37.9 ± 15.69 |
| Sex: Female, Male(Participants) | Moxifloxacin | Ofloxacin | Total |
|---|---|---|---|
| Female | 254 | 265 | 519 |
| Male | 235 | 228 | 463 |
The record gives a start of May 2012, a primary completion of Apr 2014 and a completion of Apr 2014. It does not say whether these dates are actual or estimated.
Results were first posted in May 2015, 1 year 1 month after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Moxifloxacin