Study to Compare the Efficacy and Safety of Two Non-Preserved Artificial Tears for the Treatment of Dry Eye Signs and Symptoms

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Allergan

ClinicalTrials.gov Identifier:

NCT00938704

First received: July 10, 2009

Last updated: September 22, 2011

Last verified: September 2011

History of Changes

Results First Received: September 22, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Dry Eye Syndromes
Interventions:	Drug: carboxymethylcellulose 0.5% +glycerin 0.9% Drug: sodium hyaluronate 0.18%

Participant Flow

Hide Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Carboxymethylcellulose 0.5%, Glycerin 0.9%	carboxymethylcellulose 0.5%, glycerin 0.9%
Sodium Hyaluronate 0.18%	sodium hyaluronate 0.18%

Participant Flow: Overall Study

	Carboxymethylcellulose 0.5%, Glycerin 0.9%	Sodium Hyaluronate 0.18%
STARTED	33	37
COMPLETED	33	37
NOT COMPLETED	0	0

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
Carboxymethylcellulose 0.5%, Glycerin 0.9%	carboxymethylcellulose 0.5%, glycerin 0.9%
Sodium Hyaluronate 0.18%	sodium hyaluronate 0.18%
Total	Total of all reporting groups

Baseline Measures

	Carboxymethylcellulose 0.5%, Glycerin 0.9%	Sodium Hyaluronate 0.18%	Total
Number of Participants [units: participants]	33	37	70
Age [units: years] Mean ( Full Range )	54.386 ( 20.277 to 87.485 )	48.787 ( 18.942 to 84.482 )	51.5865 ( 18.942 to 87.485 )
Gender [units: participants]
Female	23	28	51
Male	10	9	19

Outcome Measures

Show All Outcome Measures

1. Primary:

Change From Baseline in Ocular Surface Disease Index (OSDI) at Week 2 [ Time Frame: Baseline, Week 2 ]

Show Outcome Measure 1

2. Secondary:

Change From Baseline in Tear Breakup Time (TBUT) at Week 2 [ Time Frame: Baseline, Week 2 ]

Show Outcome Measure 2

3. Secondary:

Change From Baseline in Corneal Staining at Week 2 [ Time Frame: Baseline, Week 2 ]

Show Outcome Measure 3

4. Secondary:

Change From Baseline in Conjunctival Staining (Temporal) at Week 2 [ Time Frame: Baseline, Week 2 ]

Show Outcome Measure 4

5. Secondary:

Change From Baseline in Conjunctival Staining (Nasal) at Week 2 [ Time Frame: Baseline, Week 2 ]

Show Outcome Measure 5

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

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: A 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 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.

Limitations and Caveats

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
No text entered.

Results Point of Contact:

Name/Title: Vice President Medical Affairs
Organization: Allergan, Inc.
phone: 714-246-4500
e-mail: clinicaltrials@allergan.com

No publications provided

Responsible Party:	Allergan
ClinicalTrials.gov Identifier:	NCT00938704 History of Changes
Other Study ID Numbers:	MA-OPT-09-002
Study First Received:	July 10, 2009
Results First Received:	September 22, 2011
Last Updated:	September 22, 2011
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

To Top