VIGADEXA Gel Compared to VIGADEXA Solution Following Cataract Surgery

NCT01515826 | Withdrawn Phase 3

• 1 other identifier: C-10-013
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Cataracts

Keywords

Cataract surgery; Topical therapy; Prevention of inflammation; Inflammation of infection

Outcome Measures

Primary Outcomes (2)

• Percentage of patients with a score of 0 (<5 cells) for cells in the anterior chamber

  As assessed by the investigator during slit-lamp examination.

  Day 15 post-operative

• Percentage of patients with no clinically evidenced bacterial infection

  As assessed by the investigator during slit-lamp examination.

  Day 15 post-operative

Secondary Outcomes (3)

• Cells in the anterior chamber (study eye)

  Day 15 post-operative

• Ocular pain (study eye)

  Day 15 post-operative

• Inflammatory reaction (study eye)

  Day 15 post-operative

Study Arms (2)

VIGADEXA Gel

EXPERIMENTAL

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)

VIGADEXA Solution

ACTIVE COMPARATOR

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)

Interventions

Moxifloxacin 0.5%/Dexamethasone Phosphate 0.075% Ophthalmic Gel (VIGADEXA Gel) DRUG

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.

Also known as: FID 119149, VIGADEXA Gel

VIGADEXA Gel

Moxifloxacin 0.5%/Dexamethasone Phosphate 0.1% Ophthalmic Solution (VIGADEXA Solution) DRUG

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.

Also known as: VIGADEXA Solution

VIGADEXA Solution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alcon Research: lead

MeSH Terms

Conditions

Cataract

Interventions

Moxifloxacin; dexamethasone 21-phosphate; Ophthalmic Solutions

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2012
• First Posted: January 24, 2012
• Study Start: March 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: March 26, 2014

Record last verified: 2014-03