DisCoVisc Comparative Evaluation

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ClinicalTrials.gov Identifier: NCT00732225

Recruitment Status : Completed

First Posted : August 11, 2008

Results First Posted : July 30, 2010

Last Update Posted : July 30, 2010

Sponsor:

Information provided by:

Alcon Research

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Treatment
Condition:	Cataracts
Interventions:	Device: DisCoVisc Device: DuoVisc Device: BioVisc Device: Healon5 Device: Amvisc Plus

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Preoperatively, subjects were examined to ensure they met the inclusion/exclusion criteria. Patients were >49 years of age, of any race and either gender. Patients had operable cataracts in at least one eye and were able to provide informed consent

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
As access to Ophthalmic Viscosurgical Devices (OVDs) was limited, patients received whichever OVD was in stock at the time of surgery. 51 patients had a different OVD used in each eye. As a result, their demographic data is included in 2 OVD groups, resulting in a total of 224 patients (when group totals are added).

Reporting Groups

	Description
DisCoVisc	Alcon DisCoVisc Ophthalmic Viscosurgical Device (OVD) (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate)
DuoVisc	Alcon DuoVisc Ophthalmic Viscosurgical System (1% sodium hyaluronate, and 3% sodium hyaluronate, 4% chondroitin sulfate)
BioVisc	Sophia Lab BioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate)
Healon5	AMO Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate)
AmviscPlus	Bausch & Lomb AmviscPlus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate)

Participant Flow: Overall Study

	DisCoVisc	DuoVisc	BioVisc	Healon5	AmviscPlus
STARTED	71 ^[1]	40 ^[2]	26 ^[3]	33 ^[4]	54 ^[5]
COMPLETED	60 ^[6]	32 ^[7]	23 ^[8]	29 ^[9]	48 ^[10]
NOT COMPLETED	11	8	3	4	6

^[1]	76 eyes of 71 patients
^[2]	41 eyes of 40 patients
^[3]	26 eyes of 26 patients
^[4]	33 eyes of 33 patients
^[5]	55 eyes of 54 patients
^[6]	64 eyes of 60 patients
^[7]	33 eyes of 32 patients
^[8]	23 eyes of 23 patients
^[9]	29 eyes of 29 patients
^[10]	48 eyes of 48 patients

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
DisCoVisc	Alcon DisCoVisc Ophthalmic Viscosurgical Device (OVD) (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate)
DuoVisc	Alcon DuoVisc Ophthalmic Viscosurgical System (1% sodium hyaluronate, and 3% sodium hyaluronate, 4% chondroitin sulfate)
BioVisc	Sophia Lab BioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate)
Healon5	AMO Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate)
AmviscPlus	Bausch & Lomb AmviscPlus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate)
Total	Total of all reporting groups

Baseline Measures

DisCoVisc

DuoVisc

BioVisc

Healon5

AmviscPlus

Total

Overall Participants Analyzed
[Units: Participants]

224

Age ^[1]
[Units: Years]
Mean (Standard Deviation)

66.8 (9.54)

67.31 (12.61)

71.48 (8.56)

67.03 (12.13)

66.24 (10.51)

67.9 (10.8)

^[1]	Age not available for the following: 7 Discovisc patients, 11 Duovisc patients, 3 Biovisc patients, 4 Amvisc Plus patients. Total mean age and standard deviation not calculated.

Gender ^[1]
[Units: Participants]

Female

125

Male

^[1]	Gender not available for the following: 2 Discovisc patients, 2 Duovisc patients, 1 Biovisc patient, 2 Amvisc Plus patients.

Outcome Measures

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1. Primary:

Percent Loss of Endothelial Cells [ Time Frame: 2 months following surgery ]

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2. Secondary:

Aqueous Signs - Corneal Edema [ Time Frame: 1 day after surgery ]

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3. Secondary:

Aqueous Signs – Aqueous Flare [ Time Frame: 1 day following surgery ]

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4. Secondary:

Aqueous Signs - Aqueous Cells [ Time Frame: 1 day following surgery ]

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5. Secondary:

Intraocular Pressure (IOP) [ Time Frame: 1 day following surgery ]

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6. Secondary:

Physician Survey - Anterior Chamber Dome Maintenance During Anterior Capsulotomy [ Time Frame: Time of Surgery ]

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7. Secondary:

Physician Survey - Anterior Chamber Dome Maintenance During Phacoemulsification [ Time Frame: Time of Surgery ]

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8. Secondary:

Physician Survey - Anterior Chamber Dome Maintenance During IOL Insertion [ Time Frame: Time of Surgery ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
At the time of surgery, patients were assigned to a study group based on the availability of study Ophthalmic Viscosurgical Devices (OVDs).

More Information

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Certain Agreements:

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

There IS 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.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: No paper that incorporates Sponsor Confidential Information will be submitted for publication without Sponsor's prior written agreement.

Results Point of Contact:

Name/Title: Alcon Clinical
Organization: Alcon Research, Ltd.
phone: 888.451.3937; 817.568.6725
e-mail: medinfo@alconlabs.com

Responsible Party:	Rick Potvin/Director - Global Scientific Market Affairs, Alcon Research
ClinicalTrials.gov Identifier:	NCT00732225 History of Changes
Other Study ID Numbers:	M07-015
First Submitted:	August 7, 2008
First Posted:	August 11, 2008
Results First Submitted:	March 31, 2010
Results First Posted:	July 30, 2010
Last Update Posted:	July 30, 2010

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