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

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00870103
• Collaborator: (none)
• Enrollment: 64
• Location: 1
• Arm: 1

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Cataract	Drug: Vigadexa (moxifloxacin 0.5% and dexamethasone 0.1%) eye drops	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 64 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Evaluation of the Prophylactic Efficacy and Safety of the Administration of the Combination Formulation of Moxifloxacin 0.5% and Dexamethasone 0.1% Eye Drops in Inflammation and Infection Post-cataract Surgery
• Study Start Date: Sep 1, 2008
• Actual Primary Completion Date: Feb 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Vigadexa eye drops Vigadexa (moxifloxacin 0.5% and dexamethasone 0.1%) eye drops	Drug: Vigadexa (moxifloxacin 0.5% and dexamethasone 0.1%) eye drops; 1 drop every 6 hours into the study eye

Outcome Measures

Primary Outcome Measures

1. The Percentage of Patients With a Score of Zero for Anterior Chamber Cells. [Day 15 after cataract surgery]

   The percentage of patients with a score of zero for Anterior chamber cells. Anterior chamber inflammation was evaluated based on the number of cells per high-power field measured using the narrowest slit beam of the lamp (0.5 at a height of 8mm). Anterior chamber cells was recorded on a 0-4 point scale,0 = Less than 5 cells; 1 = Mild: 5-10 cells; 2 = Moderate:11-20 cells; 3 = Marked: 21-50 cells; 4 = Severe: Greater than 50 cells / hypopyon

2. The Percentage of Patients With no Ocular Pain [Day 15 after cataract surgery]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alcon Call Center	Fort Worth	Texas	United States	76134

Sponsors and Collaborators

• Alcon Research

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00870103
• Other Study ID Numbers: RM-08-05
• First Posted: Mar 26, 2009
• Last Update Posted: Mar 9, 2010
• Last Verified: Mar 1, 2010

• Keywords provided by , ,: Cataract
• Additional relevant MeSH terms: Cataract; Inflammation; Moxifloxacin; Dexamethasone; Ophthalmic Solutions

Study Results

Participant Flow

Recruitment Details	64 patients were enrolled into the study
Pre-assignment Detail	Nonrandomized

Arm/Group Title	Vigadexa Group
Arm/Group Description	Vigadexa (moxifloxacin 0.5% and dexamethasone 0.1%) eye drops; 1 drop every 6 hours into the study eye
Period Title: Overall Study
STARTED	64
COMPLETED	60
NOT COMPLETED	4

Baseline Characteristics

Arm/Group Title	Vigadexa Group
Arm/Group Description	Vigadexa (moxifloxacin 0.5% and dexamethasone 0.1%) eye drops; 1 drop every 6 hours into the study eye
Overall Participants	64
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	21 32.8%
>=65 years	43 67.2%
Sex: Female, Male (Count of Participants)
Female	37 57.8%
Male	27 42.2%

Outcome Measures

1. Primary Outcome

Title	The Percentage of Patients With a Score of Zero for Anterior Chamber Cells.
Description	The percentage of patients with a score of zero for Anterior chamber cells. Anterior chamber inflammation was evaluated based on the number of cells per high-power field measured using the narrowest slit beam of the lamp (0.5 at a height of 8mm). Anterior chamber cells was recorded on a 0-4 point scale,0 = Less than 5 cells; 1 = Mild: 5-10 cells; 2 = Moderate:11-20 cells; 3 = Marked: 21-50 cells; 4 = Severe: Greater than 50 cells / hypopyon
Time Frame	Day 15 after cataract surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Vigadexa Group
Arm/Group Description	Vigadexa (moxifloxacin 0.5% and dexamethasone 0.1%) eye drops; 1 drop every 6 hours into the study eye
Measure Participants	60
Number [Percentage of participants]	91.7 143.3%

2. Primary Outcome

Title	The Percentage of Patients With no Ocular Pain
Time Frame	Day 15 after cataract surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Vigadexa Group
Arm/Group Description	Vigadexa (moxifloxacin 0.5% and dexamethasone 0.1%) eye drops; 1 drop every 6 hours into the study eye
Measure Participants	60
Number [Percentage of participants]	96.7 151.1%

Adverse Events

Arm/Group Title	Vigadexa Group
Arm/Group Description	Vigadexa (moxifloxacin 0.5% and dexamethasone 0.1%) eye drops; 1 drop every 6 hours into the study eye
All Cause Mortality
	Vigadexa Group
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Vigadexa Group
	Affected / at Risk (%)	# Events
Total	0/64 (0%)
Other (Not Including Serious) Adverse Events
	Vigadexa Group
	Affected / at Risk (%)	# Events
Total	0/64 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.