VIGADEXA Gel Compared to VIGADEXA Solution Following Cataract Surgery

Cataracts Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01515826
• Other study ID #: C-10-013
• Status: Withdrawn
• Phase: Phase 3
• First received: January 19, 2012
• Last updated: March 24, 2014
• Start date: March 2014
• Est. completion date: October 2014

Study information

• Verified date: March 2014
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics CommitteeBrazil: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataract
• Cataracts

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	Percentage of patients with no clinically evidenced bacterial infection	As assessed by the investigator during slit-lamp examination.	Day 15 post-operative	Yes
Secondary	Cells in the anterior chamber (study eye)	As assessed by the investigator during slit-lamp examination.	Day 15 post-operative	Yes
Secondary	Ocular pain (study eye)	As assessed by the investigator during patient interview.	Day 15 post-operative	Yes
Secondary	Inflammatory reaction (study eye)	As assessed by the investigator during slit-lamp examination.	Day 15 post-operative	Yes