VIGADEXA Gel Compared to VIGADEXA Solution Following Cataract Surgery

This study has been withdrawn prior to enrollment.
(Management decision)
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01515826
First received: January 19, 2012
Last updated: March 24, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Cataracts
Drug: Moxifloxacin 0.5%/Dexamethasone Phosphate 0.075% Ophthalmic Gel (VIGADEXA Gel)
Drug: Moxifloxacin 0.5%/Dexamethasone Phosphate 0.1% Ophthalmic Solution (VIGADEXA Solution)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of the Safety and Efficacy of VIGADEXA Ophthalmic Gel Compared to VIGADEXA Ophthalmic Solution in Preventing Inflammation and Infection Following Cataract Surgery

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Percentage of patients with a score of 0 (<5 cells) for cells in the anterior chamber [ Time Frame: Day 15 post-operative ] [ Designated as safety issue: Yes ]
    As assessed by the investigator during slit-lamp examination.

  • Percentage of patients with no clinically evidenced bacterial infection [ Time Frame: Day 15 post-operative ] [ Designated as safety issue: Yes ]
    As assessed by the investigator during slit-lamp examination.


Secondary Outcome Measures:
  • Cells in the anterior chamber (study eye) [ Time Frame: Day 15 post-operative ] [ Designated as safety issue: Yes ]
    As assessed by the investigator during slit-lamp examination.

  • Ocular pain (study eye) [ Time Frame: Day 15 post-operative ] [ Designated as safety issue: Yes ]
    As assessed by the investigator during patient interview.

  • Inflammatory reaction (study eye) [ Time Frame: Day 15 post-operative ] [ Designated as safety issue: Yes ]
    As assessed by the investigator during slit-lamp examination.


Enrollment: 0
Study Start Date: March 2014
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: VIGADEXA Gel
VIGADEXA ophthalmic gel topically administered TID to the operative eye starting the day before surgery, continuing on the day of surgery, and for 15 days following surgery.
Drug: Moxifloxacin 0.5%/Dexamethasone Phosphate 0.075% Ophthalmic Gel (VIGADEXA Gel)
One ribbon (approximately 1-1.5 cm) administered topically in the conjunctival sac of the study eye three times daily (TID), starting the day before surgery (Day -1) and continuing on the day of surgery and for 15 days following surgery.
Other Name: FID 119149, VIGADEXA Gel
Active Comparator: VIGADEXA Solution
VIGADEXA ophthalmic solution topically administered QID to the operative eye starting the day before surgery, continuing on the day of surgery, and for 15 days following surgery.
Drug: Moxifloxacin 0.5%/Dexamethasone Phosphate 0.1% Ophthalmic Solution (VIGADEXA Solution)
One drop administered topically in the conjunctival sac of the study eye four times daily (QID), starting the day before surgery (Day -1) and continuing on the day of surgery and for 15 days following surgery.
Other Name: VIGADEXA Solution

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years of age or older.
  • Diagnosis of cataract with intention to undergo routine, uncomplicated cataract surgery.
  • Able to understand and sign an informed consent form.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Glaucoma or ocular hypertension.
  • Use of topical or systemic non-steroidal anti-inflammatory drugs (NSAIDs) within 14 days 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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01515826     History of Changes
Other Study ID Numbers: C-10-013
Study First Received: January 19, 2012
Last Updated: March 24, 2014
Health Authority: Brazil: Ethics Committee
Brazil: Ministry of Health

Keywords provided by Alcon Research:
Cataract surgery
Topical therapy
Prevention of inflammation
Inflammation of infection

Additional relevant MeSH terms:
Inflammation
Cataract
Pathologic Processes
Lens Diseases
Eye Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents
Contraceptives, Oral, Combined

ClinicalTrials.gov processed this record on April 21, 2014