Evaluation of Efficacy and Safety of Intracameral Moxifloxacin for Prevention of Postcataract Endophthalmitis.

NCT02770729 | Terminated Phase 3 DMC

• 1 other identifier: Moxi-Unicamp
• Study Type: interventional
• Target: 3,640
• Locations: 1 country
• Sites: 1

Brief Summary

There has thus far been only one randomized and masked clinical trial in the world to evaluate the efficacy of the intraoperative intracameral injection of antibiotics with the objective of preventing endophthalmitis following cataract surgery. The ESCRS study from 2007 confirmed that the intracameral use of cefuroxime reduced the incidence of endophthalmitis approximately fivefold. Unlike in Europe, where this drug came to be widely used after the 2007 results, cefuroxime is not commercially available in Brazil. Many studies around the world have substituted cefuroxime with moxifloxacin, which is a drug that is easily found around the world in eye drop form. It is widely used in postoperative regimens in cases of ophthalmologic surgeries, and it is free of preservatives that are toxic to intraocular structures (corneal endothelial cells). Three studies (all respective) found that the intracameral use of moxifloxacin is safe and effective for preventing endophthalmitis following cataract surgery; however, no controlled, randomized, and masked clinical trials have been performed with this objective. If this trial confirms its hypothesis (a reduction in the incidence of endophthalmitis following cataract surgery) and if minimal side effects are reported, moxifloxacin may be an option for routine intracameral use during cataract surgery, thus reducing cases of endophthalmitis and consequent cases of blindness.

Conditions

Endophthalmitis

Keywords

intracameral moxifloxacin; endophthalmitis; Vigamox; endothelial cell density

Outcome Measures

Primary Outcomes (1)

• Endophthalmitis incidence

  Endophthalmitis incidence in each group

  45 days

Secondary Outcomes (1)

• Endothelial cell count

  45 days

Study Arms (2)

Intracameral moxifloxacin

ACTIVE COMPARATOR

Intracameral injection of 0.5% moxifloxacin at conclusion of cataract surgery (150 micrograms)

Drug: Moxifloxacin

No injection of moxifloxacin

SHAM COMPARATOR

No injection of moxifloxacin at conclusion of cataract surgery

Drug: No injection of moxifloxacin

Interventions

Moxifloxacin DRUG

Intracameral injection of moxifloxacin at conclusion of cataract surgery

Also known as: Vigamox

Intracameral moxifloxacin

No injection of moxifloxacin DRUG

No intracameral injection of moxifloxacin at conclusion of cataract surgery

Also known as: No Injection

No injection of moxifloxacin

Eligibility Criteria

• Age: 40 Years - 110 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of visually significant cataract

You may not qualify if:

• Moxifloxacin allergy
• Traumatic cataract with ocular perforation
• Cataract surgery associated with other procedures, such as glaucoma filtering surgery, vitreoretinal surgery, and cornea surgery
• Signs of ocular or periocular infection
• Advanced glaucoma
• Severe dry eye

Sponsors & Collaborators

• University of Campinas, Brazil: lead

Study Sites (1)

Mathias Violante Mélega

Campinas, São Paulo, 13025-050, Brazil

Location

Related Publications (13)

• Arieta CE, de Oliveira DF, Lupinacci AP, Novaes P, Paccola M, Jose NK, Limburg H. Cataract remains an important cause of blindness in Campinas, Brazil. Ophthalmic Epidemiol. 2009 Jan-Feb;16(1):58-63. doi: 10.1080/09286580802575032.

  PMID: 19191183 BACKGROUND

• Melo GB, Bispo PJ, Regatieri CV, Yu MC, Pignatari AC, Hofling-Lima AL. Incidence of endophthalmitis after cataract surgery (2002-2008) at a Brazilian university-hospital. Arq Bras Oftalmol. 2010 Nov-Dec;73(6):505-7. doi: 10.1590/s0004-27492010000600007.

  PMID: 21271024 BACKGROUND

• Friling E, Lundstrom M, Stenevi U, Montan P. Six-year incidence of endophthalmitis after cataract surgery: Swedish national study. J Cataract Refract Surg. 2013 Jan;39(1):15-21. doi: 10.1016/j.jcrs.2012.10.037.

  PMID: 23245359 BACKGROUND

• Endophthalmitis Study Group, European Society of Cataract & Refractive Surgeons. Prophylaxis of postoperative endophthalmitis following cataract surgery: results of the ESCRS multicenter study and identification of risk factors. J Cataract Refract Surg. 2007 Jun;33(6):978-88. doi: 10.1016/j.jcrs.2007.02.032.

  PMID: 17531690 BACKGROUND

• Kowalski RP, Romanowski EG, Mah FS, Yates KA, Gordon YJ. Intracameral Vigamox (moxifloxacin 0.5%) is non-toxic and effective in preventing endophthalmitis in a rabbit model. Am J Ophthalmol. 2005 Sep;140(3):497-504. doi: 10.1016/j.ajo.2005.04.015.

  PMID: 16083841 BACKGROUND

• Kim SY, Park YH, Lee YC. Comparison of the effect of intracameral moxifloxacin, levofloxacin and cefazolin on rabbit corneal endothelial cells. Clin Exp Ophthalmol. 2008 May;36(4):367-70. doi: 10.1111/j.1442-9071.2008.01771.x.

  PMID: 18700925 BACKGROUND

• Lane SS, Osher RH, Masket S, Belani S. Evaluation of the safety of prophylactic intracameral moxifloxacin in cataract surgery. J Cataract Refract Surg. 2008 Sep;34(9):1451-9. doi: 10.1016/j.jcrs.2008.05.034.

  PMID: 18721703 BACKGROUND

• Espiritu CR, Caparas VL, Bolinao JG. Safety of prophylactic intracameral moxifloxacin 0.5% ophthalmic solution in cataract surgery patients. J Cataract Refract Surg. 2007 Jan;33(1):63-8. doi: 10.1016/j.jcrs.2006.09.019.

  PMID: 17189795 BACKGROUND

• Matsuura K, Miyoshi T, Suto C, Akura J, Inoue Y. Efficacy and safety of prophylactic intracameral moxifloxacin injection in Japan. J Cataract Refract Surg. 2013 Nov;39(11):1702-6. doi: 10.1016/j.jcrs.2013.05.036. Epub 2013 Sep 18.

  PMID: 24054967 BACKGROUND

• Matsuura K, Suto C, Akura J, Inoue Y. Comparison between intracameral moxifloxacin administration methods by assessing intraocular concentrations and drug kinetics. Graefes Arch Clin Exp Ophthalmol. 2013 Aug;251(8):1955-9. doi: 10.1007/s00417-013-2294-7. Epub 2013 Apr 2.

  PMID: 23546399 BACKGROUND

• Javitt JC. Intracameral Antibiotics Reduce the Risk of Endophthalmitis after Cataract Surgery: Does the Preponderance of the Evidence Mandate a Global Change in Practice? Ophthalmology. 2016 Feb;123(2):226-231. doi: 10.1016/j.ophtha.2015.12.011. No abstract available.

  PMID: 26802702 BACKGROUND

• Shorstein NH, Winthrop KL, Herrinton LJ. Decreased postoperative endophthalmitis rate after institution of intracameral antibiotics in a Northern California eye department. J Cataract Refract Surg. 2013 Jan;39(1):8-14. doi: 10.1016/j.jcrs.2012.07.031. Epub 2012 Oct 2.

  PMID: 23036356 BACKGROUND

• Haripriya A, Chang DF, Namburar S, Smita A, Ravindran RD. Efficacy of Intracameral Moxifloxacin Endophthalmitis Prophylaxis at Aravind Eye Hospital. Ophthalmology. 2016 Feb;123(2):302-308. doi: 10.1016/j.ophtha.2015.09.037. Epub 2015 Oct 30.

  PMID: 26522705 BACKGROUND

MeSH Terms

Conditions

Endophthalmitis

Interventions

Moxifloxacin

Condition Hierarchy (Ancestors)

Eye Infections; Infections; Eye Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Mathias V Mélega, MD

  University of Campinas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 11, 2016
• First Posted: May 12, 2016
• Study Start: January 1, 2017
• Primary Completion: February 1, 2018
• Study Completion: May 7, 2018
• Last Updated: August 21, 2018

Record last verified: 2018-08

Locations

BR (1)