Safety and Tolerability of Artificial Tears in Dry Eye Subjects

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Allergan

ClinicalTrials.gov Identifier:

NCT00932477

First received: July 1, 2009

Last updated: November 9, 2011

Last verified: November 2011

History of Changes

Results First Received: November 9, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety Study; Intervention Model: Crossover Assignment; Masking: Double Blind (Subject, Investigator)
Condition:	Dry Eye Syndrome
Interventions:	Drug: Formulation 1: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear Drug: Formulation 2: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear Drug: Glycerin and Polysorbate 80 based artificial tear

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
This is a 3-treatment, 3-period, 6-sequence crossover study. Each subject received all 3 products in a randomly assigned order. The subject used 1 product at a time for a duration of 1 week before switching to the next assigned product (e.g., with treatments A, B, and C, the sequences were ABC, ACB, BAC, BCA, CAB, and CBA).

Reporting Groups

	Description
Sequence ABC	Started with Treatment A: Artificial Tear Formulation 1 followed by Treatment B: Artificial Tear Formulation 2 followed by Treatment C: Glycerin and Polysorbate 80 based artificial tear
Sequence ACB	Started with Treatment A: Artificial Tear Formulation 1 followed by Treatment C: Glycerin and Polysorbate 80 based artificial tear followed by Treatment B: Artificial Tear Formulation 2
Sequence BAC	Started with Treatment B: Artificial Tear Formulation 2 followed by Treatment A: Artificial Tear Formulation 1 followed by Treatment C: Glycerin and Polysorbate 80 based artificial tear
Sequence BCA	Started with Treatment B: Artificial Tear Formulation 2 followed by Treatment C: Glycerin and Polysorbate 80 based artificial tear followed by Treatment A: Artificial Tear Formulation 1
Sequence CAB	Started with Treatment C: Glycerin and Polysorbate 80 based artificial tear followed by Treatment A: Artificial Tear Formulation 1 followed by Treatment B: Artificial Tear Formulation 2
Sequence CBA	Started with Treatment C: Glycerin and Polysorbate 80 based artificial tear followed by Treatment B: Artificial Tear Formulation 2 followed by Treatment A: Artificial Tear Formulation 1

Participant Flow for 3 periods

Period 1: Treatment 1

	Sequence ABC	Sequence ACB	Sequence BAC	Sequence BCA	Sequence CAB	Sequence CBA
STARTED	7	8	9	7	8	8
COMPLETED	7	8	9	7	8	8
NOT COMPLETED	0	0	0	0	0	0

Period 2: Treatment 2

	Sequence ABC	Sequence ACB	Sequence BAC	Sequence BCA	Sequence CAB	Sequence CBA
STARTED	7	8	9	7	8	8
COMPLETED	7	8	9	7	8	8
NOT COMPLETED	0	0	0	0	0	0

Period 3: Treatment 3

	Sequence ABC	Sequence ACB	Sequence BAC	Sequence BCA	Sequence CAB	Sequence CBA
STARTED	7	8	9	7	8	8
COMPLETED	7	8	9	7	8	8
NOT COMPLETED	0	0	0	0	0	0

Baseline Characteristics

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Reporting Groups

	Description
All Study Participants	All Study Participants

Baseline Measures

	All Study Participants
Number of Participants [units: participants]	47
Age [units: years]
< 40 years	7
>= 40 years	40
Gender [units: participants]
Female	42
Male	5

Outcome Measures

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1. Primary:

Tolerability Questionnaire Mean Scores at 1 Week [ Time Frame: 1 Week ]

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2. Secondary:

Number of Patients With at Least One Severity Grade Increase in Biomicroscopy Findings at 1 Week [ Time Frame: 1 Week ]

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3. Secondary:

Best-Corrected Visual Acuity (BCVA) Status at 1 Week [ Time Frame: 1 Week ]

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4. Secondary:

The Number of Ophthalmic Adverse Events at 1 Week [ Time Frame: 1 Week ]

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Serious Adverse Events

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Other Adverse Events

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Time Frame	No text entered.
Additional Description	No text entered.

Frequency Threshold

Threshold above which other adverse events are reported	5%

Reporting Groups

	Description
Artificial Tear Formulation 1	Formulation 1 Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80 based artificial tear
Artificial Tear Formulation 2	Formulation 2 Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80 based artificial tear
Glycerin and Polysorbate 80 Based Artificial Tear	Glycerin and Polysorbate 80 based artificial tear

Other Adverse Events

	Artificial Tear Formulation 1	Artificial Tear Formulation 2	Glycerin and Polysorbate 80 Based Artificial Tear
Total, other (not including serious) adverse events
# participants affected / at risk	0/47	0/47	0/47

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

No publications provided

Responsible Party:	Allergan
ClinicalTrials.gov Identifier:	NCT00932477 History of Changes
Other Study ID Numbers:	AG9965-001
Study First Received:	July 1, 2009
Results First Received:	November 9, 2011
Last Updated:	November 9, 2011
Health Authority:	United States: Institutional Review Board

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