Study of Efficacy and Safety of Vigadexa in Treating Inflammation and Infection Post-cataract Surgery

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Alcon

Status and phase

Completed
Phase 4

Conditions

Cataract

Treatments

Drug: Vigadexa (moxifloxacin 0.5% and dexamethasone 0.1%) eye drops

Study type

Interventional

Funder types

Industry

Identifiers

NCT00870103
RM-08-05

Details and patient eligibility

About

To demonstrate that the combination formulation of Moxifloxacin/Dexamethasone Eye Drop is effective and safe for the prevention of postoperative inflammation as a consequence of cataract extraction surgery.

Enrollment

64 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • ≧18 years of age
  • able to sign an informed consent and complete all required visits
  • intends to have a cataract extraction surgery followed by implantation of a posterior chamber Intraocular lens (IOL)
  • Intraocular Pressure (IOP) ≦ 20 millimeters mercury (mmHg)

Exclusion criteria

  • Uncontrolled glaucoma or IOP
  • use of ocular anti-infectious during the study and within 30 days prior to the enrollment, secondary implantation or replacement of IOL in the study eye
  • use of steroid during the study or within 14 days prior to enrollment

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

64 participants in 1 patient group

Vigadexa eye drops
Experimental group
Description:
Vigadexa (moxifloxacin 0.5% and dexamethasone 0.1%) eye drops
Treatment:
Drug: Vigadexa (moxifloxacin 0.5% and dexamethasone 0.1%) eye drops

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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