Cataract SenilePhase 4NCT04403334
Postoperative Safety Outcomes of Intraoperative Intracameral Preservative-Free Moxifloxacin Versus Levofloxacin
A Phase 4 study testing Levofloxacin Ophthalmic and Moxifloxacin Ophthalmic in people with Cataract Senile and Endophthalmitis, run by Peregrine Eye and Laser Institute at 1 site in Philippines.
Trial summary
Comparative safety study of intracameral levofloxacin versus moxifloxacin for postoperative infection prophylaxis Read more about this study
- Who is it for?
- Ages 21 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Cataract Senile, Endophthalmitis, Antibiotic Side Effect
- What is being tested?
- Levofloxacin Ophthalmic and Moxifloxacin Ophthalmic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 sitePhilippines
- Study dates
- 2 Jan 2018to 28 Apr 2018
- Phase
- Phase 4
- 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 21 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Eyes undergoing uncomplicated cataract surgery by phacoemulsification
Who cannot join
- Corneal opacities, corneal dystrophies, glaucoma, uveitis, retinopathy, optic neuropathy, concomitant infection (blepharitis, hordeolum, or conjunctivitis) or uncontrolled systemic disease and intraoperative complications that may affect visual outcomes were excluded from the study
Trial locations and contacts
1 site in 1 country.
Philippines1 site
Peregrine Eye and Laser Instittute
Makati City, MM, 1209
About this study
Official title: Postoperative Safety Outcomes in Patients Undergoing Routine Phacoemulsification Cataract Surgery With Intraoperative Intracameral Injection of Preservative-Free Moxifloxacin Versus Levofloxacin
Comparative safety study of intracameral levofloxacin versus moxifloxacin for postoperative infection prophylaxis
Read the detailed description
Randomized clinical trial comparing corneal and retinal changes after intracameral levofloxacin or moxifloxacin administered at the end of surgery among eyes undergoing uncomplicated phacoemulsification.
- Being tested
- Levofloxacin Ophthalmic, Moxifloxacin Ophthalmic
- Keywords
- levofloxacin, moxifloxacin, prophylaxis, endophthalmitis, cataract surgery
- Medical subject headings
- Endophthalmitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levofloxacin OphthalmicDrug
0.1 ml of unpreserved 0.5% levofloxacin
Moxifloxacin OphthalmicDrug
0.1 ml of unpreserved 0.5% moxifloxacin
| Study group | Role | What they receive |
|---|---|---|
| Intracameral levofloxacin | Experimental | 0.5% unpreserved solution Receives: Drug: Levofloxacin Ophthalmic |
| Intracameral moxifloxacin | Experimental | 0.5% unpreserved solution Receives: Drug: Moxifloxacin Ophthalmic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelial Cell Count
Change in endothelial cell count as measured by specular microscopy
Measured: 3 months
Central Retina Thickness
Change in central retinal thickness as measured by spectral domain optical coherence tomography
Measured: 3 months
Secondary outcomes (1)
Adverse Events
Onset of Adverse events following intervention
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2020
- Study start2 Jan 2018
- Primary completion28 Apr 2018
- Study completion28 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cataract SenileStudies 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 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peregrine Eye and Laser Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Harvey Siy Uy, Peregrine Eye and Laser Institute
- Investigators
- Harvey S Uy, MD, Principal investigator, Peregrine Eye and Laser Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04403334
- Sponsor's protocol ID
- 20180101
- Status last verified
- May 2020
- First submitted
- 21 May 2020
- Last updated
- 27 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Safety Outcomes in Patients Undergoing Routine Phacoemulsification Cataract Surgery With Intraoperative Intracameral Injection of Preservative-Free Moxifloxacin Versus Levofloxacin
- ClinicalTrials.gov ID
- NCT04403334
- Acronym / sponsor ID
- 20180101
- Keywords
- levofloxacin, moxifloxacin, prophylaxis, endophthalmitis, cataract surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Peregrine Eye and Laser InstituteUniversity, hospital or other
- Study start
- 2 Jan 2018 (actual)
- Primary completion
- 28 Apr 2018 (actual)
- Study completion
- 28 Apr 2018 (actual)
- First posted
- 27 May 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.
Comparative safety study of intracameral levofloxacin versus moxifloxacin for postoperative infection prophylaxis
Detailed description
Randomized clinical trial comparing corneal and retinal changes after intracameral levofloxacin or moxifloxacin administered at the end of surgery among eyes undergoing uncomplicated phacoemulsification.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intracameral levofloxacin | Experimental | Drug: Levofloxacin Ophthalmic0.5% unpreserved solution |
| Intracameral moxifloxacin | Experimental | Drug: Moxifloxacin Ophthalmic0.5% unpreserved solution |
Who may qualify
- Ages
- 21 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Eyes undergoing uncomplicated cataract surgery by phacoemulsification
Key exclusion criteria (1 listed)
- Corneal opacities, corneal dystrophies, glaucoma, uveitis, retinopathy, optic neuropathy, concomitant infection (blepharitis, hordeolum, or conjunctivitis) or uncontrolled systemic disease and intraoperative complications that may affect visual outcomes were excluded from the study
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 |
|---|---|---|
| Levofloxacin Ophthalmic0.1 ml of unpreserved 0.5% levofloxacin | Drug | Intracameral levofloxacin |
| Moxifloxacin Ophthalmic0.1 ml of unpreserved 0.5% moxifloxacin | Drug | Intracameral moxifloxacin |
Primary outcome
Endothelial Cell Count
Time frame: 3 months
Change in endothelial cell count as measured by specular microscopy
Central Retina Thickness
Time frame: 3 months
Change in central retinal thickness as measured by spectral domain optical coherence tomography
1 secondary outcome
Adverse Events
Time frame: 3 months
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 27 May 2020.
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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.
Harvey S Uy, MD principal investigator
Peregrine Eye and Laser Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Levofloxacin Ophthalmic and Moxifloxacin Ophthalmic in people with Cataract Senile and Endophthalmitis, run by Peregrine Eye and Laser Institute at 1 site in Philippines.
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 1 inclusion and 1 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 27 May 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 Philippines. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Endothelial Cell Count (time frame: 3 months). The study lists 2 primary outcomes in all. 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 27 May 2020.