DisCoVisc Versus Competitor

This study is currently recruiting participants.

Verified by Alcon Research, July 2008

First Received: July 7, 2008 Last Updated: July 8, 2008 History of Changes

Sponsored by:	Alcon Research
Information provided by:	Alcon Research
ClinicalTrials.gov Identifier:	NCT00712244

Purpose

A comparison of the ability of DisCoVisc to that of other OVDs (DuoVisc, Healon5 or Amvisc PLUS) regarding endothelial protection and anterior chamber space maintenance during non-eventful cataract surgery.

Condition	Intervention	Phase
Cataract	Device: DisCoVisc Device: DuoVisc Device: Healon5 Device: Amvisc Plus	Phase IV

MedlinePlus related topics: Cataract

Drug Information available for: Hyaluronic acid Hyaluronate Sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Parallel Assignment

Further study details as provided by Alcon Research:

Primary Outcome Measures:

Corneal Endothelial Cell Loss [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Pachymetry [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Estimated Enrollment:	120
Study Start Date:	October 2007
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator DisCoVisc	Device: DisCoVisc DisCoVisc OVD (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate)
2: Active Comparator DuoVisc	Device: DuoVisc DuoVisc OVD (1% sodium hyaluronate, and 3% sodium hyaluronate, 4% chondroitin sulfate)
3: Active Comparator Healon5	Device: Healon5 Healon5 OVD (2.3% Sodium Hyaluronate)
4: Active Comparator Amvisc Plus	Device: Amvisc Plus Amvisc Plus OVD (1.6% Sodium Hyaluronate)

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

operable cataracts in at least one eye

Exclusion Criteria:

ECC ≤1500cells/mm2; IOP > 21mm Hg
previous ocular inflammation
systemic or ocular conditions affecting corneal endotheliumECC ≤1500cells/mm2
IOP > 21mm Hg
previous ocular inflammation
systemic or ocular conditions affecting corneal endothelium

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00712244

Contacts

Contact: Alcon Call Center

1-888-451-3937

Locations

United States, Texas
Contact Alcon Call Center for Study Locations	Recruiting
Fort Worth, Texas, United States, 76134

Sponsors and Collaborators

Alcon Research

More Information

No publications provided

Responsible Party:	Alcon ( Rick Potvin )
Study ID Numbers:	M07-014
Study First Received:	July 7, 2008
Last Updated:	July 8, 2008
ClinicalTrials.gov Identifier:	NCT00712244 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Alcon Research:

Discovisc OVD
Ophthalmic Viscosurgical Device

Study placed in the following topic categories:

Immunologic Factors
Hyaluronic Acid
Eye Diseases

Cataract
Adjuvants, Immunologic
Lens Diseases

Additional relevant MeSH terms:

Immunologic Factors
Hyaluronic Acid
Eye Diseases
Cataract

Physiological Effects of Drugs
Adjuvants, Immunologic
Lens Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009