VIGADEXA Gel Compared to VIGADEXA Solution Following Cataract Surgery

Last updated: March 24, 2014
Sponsor: Alcon Research
Overall Status: Trial Not Available

Phase

3

Condition

Inflammation

Cataracts

Eye Disorders/infections

Treatment

N/A

Clinical Study ID

NCT01515826
C-10-013
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to compare VIGADEXA (moxifloxacin 0.5%/dexamethasone phosphate 0.075%) ophthalmic gel to VIGADEXA (moxifloxacin 0.5%/dexamethasone phosphate 0.1%) ophthalmic solution in the prevention of postoperative inflammation and infection.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 18 years of age or older.

  • Diagnosis of cataract with intention to undergo routine, uncomplicated cataractsurgery.

  • Able to understand and sign an informed consent form.

  • Other protocol-defined inclusion criteria may apply.

Exclusion

Exclusion Criteria:

  • Glaucoma or ocular hypertension.

  • Use of topical or systemic non-steroidal anti-inflammatory drugs (NSAIDs) within 14days prior to surgery or planned use during the study. Low-dose acetylsalicylic acid (up to 100 mg/day) is allowed.

  • Use of anti-bacterial, anti-viral, or anti-fungal agents or ocular medications within 30 days prior to enrollment in the study or during study, as specified by protocol.

  • Secondary implantation or replacement of the intra-ocular lens (IOL) in the study eye.

  • Planned use of contact lenses in the study eye during the study period.

  • Cataract surgery in the contralateral eye within 30 days prior to the Screening Visit,or planned for the 3 weeks after the cataract surgery in the study eye.

  • History of clinically significant trauma to the study eye within the past 12 months.

  • Other protocol-defined exclusion criteria may apply.

Study Design

Study Start date:
March 01, 2014
Estimated Completion Date:
October 31, 2014

Connect with a study center

  • UNIFESP - Departamento de Oftalmologia

    Sao Paulo, 04023-062
    Brazil

    Site Not Available

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