A Phase 4 interventional study of Vigamox Ophthalmic Solution and BSS placebo in Bacterial Conjunctivitis, sponsored by Alcon Research. Completed at 1 site in United States. Open to participants aged 1 Year and older. Per ClinicalTrials.gov, last updated 2010-03-31.
Sponsored by Alcon Research (part of Alcon) · Phase 4, Interventional, and Treatment
The primary objective of this study is to investigate the initial antibiotic effects in the treatment of bacterial conjunctivitis symptoms in subjects one year of age and older.
40 studies on the registry are indexed under Conjunctivitis, Bacterial; 2 are open to participants now.
This study's enrollment of 24 is below 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.
Diagnosis in one or both eyes of bacterial conjunctivitis based on:
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.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Vigamox Ophthalmic Solution (Moxifloxacin 5mg/mL)
Drug: Vigamox Ophthalmic Solution
Balanced Salt Solution
Drug: BSS placebo
Moxifloxacin 5mg/mL 3 times daily for 7 days
Balanced Saline Solution for 3 doses, then Moxifloxacin 5mg/mL 3 times daily for 7 days
Exploratory Outcomes From Digital Photography
Photographs were taken before and after treatment. Outcome is the number of patients whose photographs showed a subjective visual change based upon an exploratory review of patient photographs in signs of bacterial conjunctivitis before and after treatment.
Time frame: 24 hours after administration of first dose
Exploratory Evaluation of Changes in Ocular Signs and Symptoms
Number of patients who had clinical resolution (0 on all scales below) from baseline (Day 1) to Day 2 in ocular and symptoms of bacterial conjunctivitis: Bulbar Conjunctival Injection - 0 (none) to 4 (Severe) scale. Conjunctival Discharge (Mucopurulent) - 0 (none) to 3 (Severe) scale. Lid Erythema - 0 (none) to 3 (Severe) scale. Lid Swelling - 0 (none) to 3 (Severe) scale. Palpebral Conjunctiva - 0 (none) to 3 (Severe) scale. Foreign Body Sensation - 0 (none) to 3 (Severe) scale. Tearing - 0 (none) to 3 (Severe) scale. Photophobia - 0 (none) to 3 (Severe) scale.
Time frame: Baseline (Day 1) to Day 2
Microbiological Culture Evaluation/Eradication Percent - Enterobacter Faecalis and Candida Albicans
Eradication percent (absence of specified bacteria) of each bacteria identified at Day 1
Time frame: 24 hours after administration of first dose
Microbiological Culture Evaluation/Eradication Percent - Eradication of All Other Isolates and Corynform-like
Eradication percent (absence of specified bacteria) of each bacteria identified at Day 1
Time frame: 24 hour after administration of first dose
Microbiological Culture Evaluation/Eradication Percent - Staphylococcus Aureus, Steptococcus Pneumoniae, and Enterobacter Cloacae
Eradication percent (absence of specified bacteria) of each bacteria identified at Day 1
Time frame: 24 hours after administration of first dose
| Milestone | Vigamox | Placebo |
|---|---|---|
| Started | 17 | 7 |
| Completed | 17 | 7 |
| Not completed | 0 | 0 |
Photographs were taken before and after treatment. Outcome is the number of patients whose photographs showed a subjective visual change based upon an exploratory review of patient photographs in signs of bacterial conjunctivitis before and after treatment.
| Participants | Vigamox | Placebo |
|---|---|---|
| Exploratory Outcomes From Digital Photography | 17 | 7 |
Number of patients who had clinical resolution (0 on all scales below) from baseline (Day 1) to Day 2 in ocular and symptoms of bacterial conjunctivitis: Bulbar Conjunctival Injection - 0 (none) to 4 (Severe) scale. Conjunctival Discharge (Mucopurulent) - 0 (none) to 3 (Severe) scale. Lid Erythema - 0 (none) to 3 (Severe) scale. Lid Swelling - 0 (none) to 3 (Severe) scale. Palpebral Conjunctiva - 0 (none) to 3 (Severe) scale. Foreign Body Sensation - 0 (none) to 3 (Severe) scale. Tearing - 0 (none) to 3 (Severe) scale. Photophobia - 0 (none) to 3 (Severe) scale.
| Participants | Vigamox | Placebo |
|---|---|---|
| Exploratory Evaluation of Changes in Ocular Signs and Symptoms | 17 | 7 |
Eradication percent (absence of specified bacteria) of each bacteria identified at Day 1
| Percent bacteria eradicated | Vigamox | Placebo |
|---|---|---|
| Enterobacter faecalis | 17 | 100 |
| Candida albicans | 75 | 0 |
Eradication percent (absence of specified bacteria) of each bacteria identified at Day 1
| Percent bacteria eradicated | Vigamox | Placebo |
|---|---|---|
| Eradication of all other isolates | 100 | — |
| Corynform-like | 0 | — |
Eradication percent (absence of specified bacteria) of each bacteria identified at Day 1
| Percent bacteria eradicated | Vigamox | Placebo |
|---|---|---|
| Staphylococcus Aureus | — | 0 |
| Steptococcus Pneumoniae | — | 50 |
| Enterobacter Cloacae | — | 67 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Vigamox | — | 0/17 (0%) | 0/17 (0%) |
| Placebo | — | 0/7 (0%) | 0/7 (0%) |
| Age, Categorical(Participants) | Vigamox | Placebo | Total |
|---|---|---|---|
| <=18 years | 7 | 7 | 14 |
| Between 18 and 65 years | 10 | 0 | 10 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Vigamox | Placebo | Total |
|---|---|---|---|
| Female | 11 | 5 | 16 |
| Male | 6 | 2 | 8 |
This study is completed, as verified in Mar 2010. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Moxifloxacin