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CataractPhase 1NCT05741632

Safety Profile Comparison of Undiluted Intracameral Moxifloxacin vs. Levofloxacin in Cataract Surgery

A Phase 1 study testing Moxifloxacin Ophthalmic Solution and Levofloxacin Ophthalmic in people with Cataract, run by Universitas Indonesia at 1 site in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this randomized clinical trial study is to compare safety profile undiluted intracameral moxifloxacin vs levofloxacin during cataract surgery. The main question it aims to answer is whether moxifloxacin and levofloxacin have similar safety profile. Participant will be randomized into two treatment arms. Read more about this study

Who is it for?
Ages 40 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Cataract
What is being tested?
Moxifloxacin Ophthalmic Solution and Levofloxacin Ophthalmic
Could I receive a placebo?
No, everyone receives an active treatment
How many people
68 participants
Where
1 siteIndonesia
Study dates
1 Feb 2023to 1 Apr 2023
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 40 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Immature senile cataract in one or both eye
  • Agree to be included and signed informed consent

Who cannot join

  • Have a history of allergy to moxifloxacin or levofloxacin or any other antibiotics
  • Other ocular comorbid such as uveitis, glaucoma, diabetic retinopathy, pseudoexfoliation, and endothelial disorders
  • Ocular surgery prior to study
  • Sign of infection or inflammation around the eye
  • Cataract density more than grade 4 according to Lens Opacities Classification System (LOCS) III grading
  • Corneal endothelial cell density < 1500 cell/ mm2
  • Anterior chamber depth < 2.5 mm
  • Diabetes mellitus type 2

Trial locations and contacts

1 site in 1 country.

Indonesia1 site

  • Fakultas Kedokteran Universitas Indonesia

    Jakarta Pusat, DKI Jakarta, 10430

Other trials in Indonesia

About this study

The goal of this randomized clinical trial study is to compare safety profile undiluted intracameral moxifloxacin vs levofloxacin during cataract surgery. The main question it aims to answer is whether moxifloxacin and levofloxacin have similar safety profile.

Participant will be randomized into two treatment arms. All participant will receive standardized treatment before, during, and after surgery and will be followed up at one day, one week, and one month after surgery.

Read the detailed description

This study aims to observe the safety profile in patient receiving cataract surgery who receives moxifloxacin and levofloxacin intracamerally during the surgery. Safety profile defined as visual acuity, intraocular pressure, corneal endothelial cell density, central corneal thickness, anterior chamber reactions, and central macular thickness. Parameters are obtained before the surgery, 1 day, 1 week, and 1 month after surgery. Subjects are randomized to two treatment arms: (1) receiving undiluted moxifloxacin 0.1 cc during surgery; (2) receiving undiluted levofloxacin 0.1 cc during surgery.

Conditions
Cataract
Being tested
Moxifloxacin Ophthalmic Solution, Levofloxacin Ophthalmic
Keywords
Moxifloxacin, Levofloxacin, Cataract surgery
Medical subject headings
Cataract

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Moxifloxacin Ophthalmic SolutionDrug

    Also called Molcin(R)

    Moxifloxacin solution 0.1 cc undiluted, self preserved, injected into intracamera at the end of cataract surgery

  • Levofloxacin OphthalmicDrug

    Also called Cravit(R)

    Levofloxacin solution 0.1 cc undiluted, self preserved, injected into intracamera at the end of cataract surgery

Study groups in NCT05741632
Study groupRoleWhat they receive
MoxifloxacinExperimentalSubjects will receive 0.1 cc undiluted non preserved intracameral Moxifloxacin during cataract surgery.
Receives: Drug: Moxifloxacin Ophthalmic Solution
LevofloxacinActive comparatorSubjects will receive 0.1 cc undiluted non preserved intracameral Levofloxacin during cataract surgery.
Receives: Drug: Levofloxacin Ophthalmic

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Endothelial cell density

    Corneal endothelial cell density measured using specular microscopy

    Measured: 1 month

Secondary outcomes (4)

  1. Central corneal thickness

    Central corneal thickness (in nm) measured using specular microscopy

    Measured: 1 month

  2. Central macular thickness

    Central macular thickness (in nm) measure using optical coherence tomography

    Measured: 1 month

  3. Anterior chamber cell reactions

    Anterior chamber cell reactions measured in Standardization of Uveitis Nomenclature (SUN) grading. Values consist of 0, trace, 1+, 2+, 3+, and 4+. Higher grading score means more inflammatory reaction which is worse.

    Measured: 1 month

  4. Intraocular pressure

    Intraocular pressure (in mmHg) measured using automated non contact tonometer

    Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Feb 2023
  2. Study start1 Feb 2023
  3. Primary completion31 Mar 2023
  4. Study completion1 Apr 2023

Resources

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
Model description
First group will receive Moxifloxacin intracameral during surgery Second group will receive Levofloxacin intracameral during surgery
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
68 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05741632
Sponsor's protocol ID
22-10-1262
Other IDs
KET-1303/UN2.F1/ETIK/PPM.00.02
Status last verified
Aug 2023
First submitted
14 Feb 2023
Last updated
22 Aug 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Melega MV, Alves M, Cavalcanti Lira RP, Cardoso da Silva I, Ferreira BG, Assis Filho HL, Pedreira Chaves FR, Martini AAF, Dias Freire LM, Reis RD, Leite Arieta CE. Safety and efficacy of intracameral moxifloxacin for prevention of post-cataract endophthalmitis: Randomized controlled clinical trial. J Cataract Refract Surg. 2019 Mar;45(3):343-350. doi: 10.1016/j.jcrs.2018.10.044. Epub 2019 Jan 25.

    PubMed 30691922

  • Chang DF, Prajna NV, Szczotka-Flynn LB, Benetz BA, Lass JH, O'Brien RC, Menegay HJ, Gardner S, Shekar M, Rajendrababu S, Rhee DJ. Comparative corneal endothelial cell toxicity of differing intracameral moxifloxacin doses after phacoemulsification. J Cataract Refract Surg. 2020 Mar;46(3):355-359. doi: 10.1097/j.jcrs.0000000000000064.

    PubMed 32050222

  • Lucena NP, Pereira IMS, Gaete MIL, Ferreira KSA, Melega MV, Lira RPC. Intracameral moxifloxacin after cataract surgery: a prospective study. Arq Bras Oftalmol. 2018 Apr;81(2):92-94. doi: 10.5935/0004-2749.20180022.

    PubMed 29846429

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Moxifloxacin Ophthalmic Solution and Levofloxacin Ophthalmic in people with Cataract, run by Universitas Indonesia at 1 site in Indonesia.

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 8 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 22 Aug 2023. 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 Indonesia. 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 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?

Endothelial cell density (time frame: 1 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05741632, which also lists 3 linked publications.

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 22 Aug 2023.

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