Safety and Efficacy of an Artificial Tear for the Treatment of Dry Eye

This study has been completed.

Study NCT00514852 Information provided by Allergan

First Received on August 8, 2007. Last Updated on November 10, 2009 History of Changes

Results First Received: May 19, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Dry Eye Syndrome
Interventions:	Drug: Carboxymethylcellulose and Glycerin based artificial tear Drug: Carboxymethylcellulose

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
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Carboxymethylcellulose and Glycerin Based Artificial Tear	1 to 2 drops into each eye as needed but at least twice daily
Carboxymethylcellulose Based Artificial Tear	1 to 2 drops into each eye as needed but at least twice daily

Participant Flow: Overall Study

	Carboxymethylcellulose and Glycerin Based Artificial Tear	Carboxymethylcellulose Based Artificial Tear
STARTED	157	159
COMPLETED	152	154
NOT COMPLETED	5	5

Baseline Characteristics

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Reporting Groups

	Description
Carboxymethylcellulose and Glycerin Based Artificial Tear	1 to 2 drops into each eye as needed but at least twice daily
Carboxymethylcellulose Based Artificial Tear	1 to 2 drops into each eye as needed but at least twice daily

Baseline Measures

	Carboxymethylcellulose and Glycerin Based Artificial Tear	Carboxymethylcellulose Based Artificial Tear	Total
Number of Participants [units: participants]	157	159	316
Age, Customized [units: participants]
<40 years	18	15	33
>=40 years	139	144	283
Gender [units: participants]
Female	120	125	245
Male	37	34	71

Outcome Measures

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1. Primary:

Change From Baseline at Day 30 in Ocular Surface Disease Index© Questionnaire Score [ Time Frame: Change from baseline at Day 30 ]

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2. Secondary:

Change From Baseline at Day 30 in Schirmer Test, With Anesthesia [ Time Frame: Change from baseline at Day 30 ]

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3. Secondary:

Change From Baseline at Day 30 in Tear Break-Up Time, With Fluorescein [ Time Frame: Change from baseline at Day 30 ]

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4. Secondary:

Patient Acceptability Score (Dryness) at Day 30 [ Time Frame: Day 30 ]

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5. Secondary:

Patient Acceptability Score (Vision) at Day 30 [ Time Frame: Day 30 ]

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6. Secondary:

Change From Baseline at Day 30 in Ocular Surface (Corneal) Staining With Fluorescein [ Time Frame: Change from baseline at Day 30 ]

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7. Secondary:

Change From Baseline at Day 30 in Ocular Surface (Conjunctival) Staining With Fluorescein [ Time Frame: Change from baseline at Day 30 ]

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8. Secondary:

Change From Baseline at Day 30 in Subjective Evaluation of Symptom of Dryness Score [ Time Frame: Change from baseline at Day 30 ]

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9. Post-Hoc:

Vision Subscale of the Ocular Surface Disease Index Questionnaire© at Day 30 [ Time Frame: Day 30 ]

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10. Post-Hoc:

Ocular Surface Staining With Fluorescein (Central Cornea) at Day 30 [ Time Frame: Day 30 ]

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Serious Adverse Events

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Other Adverse Events

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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: 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 more than 60 days but 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
N/A

Results Point of Contact:

Name/Title: Therapeutic Area Head
Organization: Allergan, Inc.
phone: (714)246-4500
e-mail: clinicaltrials@allergan.com

No publications provided

Responsible Party:	Therapeutic Area Head, Allergan, Inc.
ClinicalTrials.gov Identifier:	NCT00514852 History of Changes
Other Study ID Numbers:	AG9818-002
Study First Received:	August 8, 2007
Results First Received:	May 19, 2009
Last Updated:	November 10, 2009
Health Authority:	United States: Institutional Review Board