Microbial DiseasePhase 1NCT04542759
Effect of Topical Besifloxacin on Ocular Surface Bacterial Microbiota Prior to Cataract Surgery
A Phase 1 study testing Besifloxacin Ophthalmic and Hydroxypropyl Methylcellulose Ophthalmic Ophthalmic Solution in people with Microbial Disease and Cataract Senile, run by Instituto de Oftalmología Fundación Conde de Valenciana at 1 site in Mexico.
Trial summary
Describe the efficacy of the use of topical besifloxacin in reducing the conjunctival microbiota as a prophylactic measure in patients scheduled for cataract surgery. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Microbial Disease, Cataract Senile
- What is being tested?
- Besifloxacin Ophthalmic and Hydroxypropyl Methylcellulose Ophthalmic Ophthalmic Solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteMexico
- Study dates
- Jan 2017to Apr 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects over 18 years of age scheduled for cataract surgery in the established study period.
- Subjects physically and mentally capable of applying the eye drops or having a person available to help in the correct administration of the eye drops 4 times a day.
Who cannot join
- - Active eye infection (bacterial, viral, fungal or parasitic) such as blepharitis and / or conjunctivitis.
- Known allergy or any contraindication to the use of quinolones or any of the components of the drugs.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Institute of Ophthalmology, Conde de Valenciana Foundation
Mexico City, Mexico City, 06800
About this study
Describe the efficacy of the use of topical besifloxacin in reducing the conjunctival microbiota as a prophylactic measure in patients scheduled for cataract surgery.
Read the detailed description
Randomized double-blind clinical trial. Study carried out in a single center between January and April 2017. 60 eyes were included that were randomly divided in a 1: 1 ratio into two groups. The first group received placebo (hydroxypropylmethylcellulose drops) while the second group received 0.6% besifloxacin drops four times a day for 3 days. All of them had a conjunctival cul-de-sac culture before and after treatment.
- Conditions
- Microbial Disease, Cataract Senile
- Being tested
- Besifloxacin Ophthalmic, Hydroxypropyl Methylcellulose Ophthalmic Ophthalmic Solution
- Keywords
- Besifloxacin, prophylaxis, cataract surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Besifloxacin OphthalmicDrug
Also called Besivance ophthalmic suspension 0.6%
Prophylaxis for endophthalmitis
Hydroxypropyl Methylcellulose Ophthalmic Ophthalmic SolutionDrug
Also called Artelac eye drops
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Besifloxacin | Active comparator | 1 DROP 4 TIMES A DAY FOR 3 DAYS PRIOR SURGERY Receives: Drug: Besifloxacin Ophthalmic |
| Hydroxypropyl methylcellulose | Placebo comparator | 1 DROP 4 TIMES A DAY FOR 3 DAYS PRIOR SURGERY Receives: Drug: Hydroxypropyl Methylcellulose Ophthalmic Ophthalmic Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of positive cultures before and after treatment in each arm
A conjunctival cul-de-sac sample will be taken before starting treatment and before surgery, which will be cultured on 3 different media types: Blood, Chocolate and Sabouraud agar.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2020
- Study startJan 2017
- Primary completionApr 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Microbial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Oftalmología Fundación Conde de Valenciana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eduardo Chavez-Mondragon, MD, Study director, Instutute of Ophthalmology "Conde de Valenciana"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04542759
- Sponsor's protocol ID
- CI-004-215
- Status last verified
- Sep 2020
- First submitted
- 19 Aug 2020
- Last updated
- 9 Sep 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Topical Besifloxacin on Ocular Surface Bacterial Microbiota Prior to Cataract Surgery
- ClinicalTrials.gov ID
- NCT04542759
- Acronym / sponsor ID
- CI-004-215
- Conditions
- Microbial Disease, Cataract Senile
- Keywords
- Besifloxacin, prophylaxis, cataract surgery
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Instituto de Oftalmología Fundación Conde de ValencianaUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 9 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Describe the efficacy of the use of topical besifloxacin in reducing the conjunctival microbiota as a prophylactic measure in patients scheduled for cataract surgery.
Detailed description
Randomized double-blind clinical trial. Study carried out in a single center between January and April 2017. 60 eyes were included that were randomly divided in a 1: 1 ratio into two groups. The first group received placebo (hydroxypropylmethylcellulose drops) while the second group received 0.6% besifloxacin drops four times a day for 3 days. All of them had a conjunctival cul-de-sac culture before and after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Besifloxacin | Active comparator | Drug: Besifloxacin Ophthalmic1 DROP 4 TIMES A DAY FOR 3 DAYS PRIOR SURGERY |
| Hydroxypropyl methylcellulose | Placebo comparator | Drug: Hydroxypropyl Methylcellulose Ophthalmic Ophthalmic Solution1 DROP 4 TIMES A DAY FOR 3 DAYS PRIOR SURGERY |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects over 18 years of age scheduled for cataract surgery in the established study period.
- Subjects physically and mentally capable of applying the eye drops or having a person available to help in the correct administration of the eye drops 4 times a day.
Key exclusion criteria (2 listed)
- - Active eye infection (bacterial, viral, fungal or parasitic) such as blepharitis and / or conjunctivitis.
- Known allergy or any contraindication to the use of quinolones or any of the components of the drugs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Besifloxacin OphthalmicAlso: Besivance ophthalmic suspension 0.6%Prophylaxis for endophthalmitis | Drug | Besifloxacin |
| Hydroxypropyl Methylcellulose Ophthalmic Ophthalmic SolutionAlso: Artelac eye dropsPlacebo | Drug | Hydroxypropyl methylcellulose |
Primary outcome
Percentage of positive cultures before and after treatment in each arm
Time frame: Through study completion, an average of 1 year
A conjunctival cul-de-sac sample will be taken before starting treatment and before surgery, which will be cultured on 3 different media types: Blood, Chocolate and Sabouraud agar.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eduardo Chavez-Mondragon, MD study director
Instutute of Ophthalmology "Conde de Valenciana"
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Besifloxacin Ophthalmic and Hydroxypropyl Methylcellulose Ophthalmic Ophthalmic Solution in people with Microbial Disease and Cataract Senile, run by Instituto de Oftalmología Fundación Conde de Valenciana at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of positive cultures before and after treatment in each arm (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2020.