EndophthalmitisPhase 2/3NCT03244072
Safety and Efficacy of Intracameral Zimoxin for Prevention of Endophthalmitis After Cataract Surgery
A Phase 2/3 study testing Moxifloxacin in people with Endophthalmitis, run by Jason Ahee, M.D. at 1 site in United States.
Trial summary
Intracameral injection of 0.1% moxifloxacin solution after cataract surgery to prevent endophthalmitis Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Endophthalmitis
- What is being tested?
- Moxifloxacin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2027to Oct 2031
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- visually significant cataracts
Who cannot join
- allergy to fluoroquinolones, cobalamin (B12)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Zion Eye Institute
St. George, Utah, 84790
Jason Ahee, M.D.
About this study
Official title: Safety and Efficacy of Intracameral Zimoxin (0.1% Moxifloxacin Solution) for Prevention of Endophthalmitis After Cataract Surgery
Intracameral injection of 0.1% moxifloxacin solution after cataract surgery to prevent endophthalmitis
Read the detailed description
Subjects will receive either intracameral injection of 0.1% moxifloxacin solution or placebo after cataract surgery. They will be followed for one month to determine if there is a statistically significant difference in the incidence of endophthalmitis.
- Conditions
- Endophthalmitis
- Being tested
- Moxifloxacin, Placebo
- Medical subject headings
- Endophthalmitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MoxifloxacinDrug
Also called active
Intracameral injection
PlaceboDrug
Also called sham
intracameral injection
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Active comparator | Intracameral injection of moxifloxacin solution after cataract surgery Receives: Drug: Moxifloxacin |
| Placebo group | Placebo comparator | Intracameral injection of placebo after cataract surgery Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endophthalmitis after cataract surgery
Subjects will be followed after cataract surgery and have post-operative eye examinations to determine if infection in the eye (endophthalmitis) occurs during the study period.
Measured: Subjects will undergo eye examinations at one day, one week, and one month post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2017
- Study start1 Jun 2027 (estimated)
- Primary completionOct 2030 (estimated)
- Study completionOct 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndophthalmitisStudies 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jason Ahee, M.D.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, Jason Ahee, M.D., Zion Therapeutics, LLC
- Investigators
- Jason Ahee, M.D., Principal investigator, Zion Therapeutics, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03244072
- Sponsor's protocol ID
- PIND 134134
- Status last verified
- Sep 2026
- First submitted
- 4 Aug 2017
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Intracameral Zimoxin (0.1% Moxifloxacin Solution) for Prevention of Endophthalmitis After Cataract Surgery
- ClinicalTrials.gov ID
- NCT03244072
- Acronym / sponsor ID
- PIND 134134
- Conditions
- Endophthalmitis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60,000 participants (estimated)
- Lead sponsor
- Jason Ahee, M.D.Industry (pharma, biotech, devices)
- Study start
- 1 Jun 2027 (estimated)
- Primary completion
- Oct 2030 (estimated)
- Study completion
- Oct 2031 (estimated)
- First posted
- 9 Aug 2017 (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.
Intracameral injection of 0.1% moxifloxacin solution after cataract surgery to prevent endophthalmitis
Detailed description
Subjects will receive either intracameral injection of 0.1% moxifloxacin solution or placebo after cataract surgery. They will be followed for one month to determine if there is a statistically significant difference in the incidence of endophthalmitis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Active comparator | Drug: MoxifloxacinIntracameral injection of moxifloxacin solution after cataract surgery |
| Placebo group | Placebo comparator | Drug: PlaceboIntracameral injection of placebo after cataract surgery |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- visually significant cataracts
Key exclusion criteria (1 listed)
- allergy to fluoroquinolones, cobalamin (B12)
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 |
|---|---|---|
| MoxifloxacinAlso: activeIntracameral injection | Drug | Treatment group |
| PlaceboAlso: shamintracameral injection | Drug | Placebo group |
Primary outcome
Endophthalmitis after cataract surgery
Time frame: Subjects will undergo eye examinations at one day, one week, and one month post-operatively
Subjects will be followed after cataract surgery and have post-operative eye examinations to determine if infection in the eye (endophthalmitis) occurs during the study period.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Nanopore Sequencing in Ophthalmology
Endophthalmitis
Not yet recruiting
Intracameral Levofloxacin Versus Moxifloxacin After Cataract Surgery
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RecruitingPhase 1
A Study of Ear Nerve Stimulation to Treat Eye Inflammation
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Targeting Immunosuppressive Treatment for Non-infectious Uveitis Using Aqueous Humor Cytokine Profiles
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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.
Jason Ahee, M.D. principal investigator
Zion Therapeutics, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Moxifloxacin in people with Endophthalmitis, run by Jason Ahee, M.D. at 1 site in United States.
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: opening soon, as of the sponsor's last update on 15 Sep 2026. 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 United States. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jason Ahee, M.D. (435-862-9865, aheejason@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endophthalmitis after cataract surgery (time frame: Subjects will undergo eye examinations at one day, one week, and one month post-operatively). 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 15 Sep 2026.