Study of Two Marketed Ocular Anti-Allergy Medications in Subjects With Allergic Conjunctivitis - Study Results

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Investigator), Parallel Assignment
Condition:	Allergic Conjunctivitis
Interventions:	Drug: Elestat Drug: Pataday

Participant Flow

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
Elestat	1 drop each eye for 2 days
Pataday	1 drop each eye for 1 day

Participant Flow: Overall Study

	Elestat	Pataday
STARTED	40	39
COMPLETED	40	39
NOT COMPLETED	0	0

Baseline Characteristics

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Reporting Groups

	Description
Elestat	1 drop each eye for 2 days
Pataday	1 drop each eye for 1 day

Baseline Measures

	Elestat	Pataday	Total
Number of Participants [units: participants]	40	39	79
Age [units: years] Mean ± Standard Deviation	41.3 ± 12.18	40.1 ± 13.41	40.7 ± 12.73
Gender [units: participants]
Female	20	27	47
Male	20	12	32

Outcome Measures

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1. Primary:

Change in Ocular Itch Score From Baseline [ 0 hours, 12 hours ]

Measure Type	Primary
Measure Title	Change in Ocular Itch Score From Baseline
Measure Description	Ocular itch was measured on a 0 (none) to 4 (severe itch with continual desire to rub eyes) scale. Negative values for change from baseline represent favorable outcomes.
Time Frame	0 hours, 12 hours
Safety Issue	No

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
Elestat	1 drop each eye for 2 days
Pataday	1 drop each eye for 1 day

Measured Values

	Elestat	Pataday
Number of Participants Analyzed [units: participants]	40	39
Change in Ocular Itch Score From Baseline [units: units on a scale] Mean ± Standard Deviation	-1.5 ± 1.36	-1.5 ± 1.07

Statistical Analysis 1 for Change in Ocular Itch Score From Baseline

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.532

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	ITT (Intent to Treat)
[2]	Other relevant information, such as adjustments or degrees of freedom:
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[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
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2. Secondary:

Ocular Comfort Score at 12 Hours [ 12 hours ]

Measure Type	Secondary
Measure Title	Ocular Comfort Score at 12 Hours
Measure Description	Ocular comfort was measured on a 0 (more uncomfortable) to 10 (more comfortable) scale.
Time Frame	12 hours
Safety Issue	No

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.
No text entered.

Reporting Groups

	Description
Elestat	1 drop each eye for 2 days
Pataday	1 drop each eye for 1 day

Measured Values

	Elestat	Pataday
Number of Participants Analyzed [units: participants]	40	39
Ocular Comfort Score at 12 Hours [units: units on a scale] Mean ± Standard Deviation	8.6 ± 1.62	8.5 ± 1.94

Statistical Analysis 1 for Ocular Comfort Score at 12 Hours

Groups ^[1]	All groups
Method ^[2]	Student's t-test
P Value ^[3]	0.927

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	ITT (Intent to Treat)
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

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: PI cannot publish or discuss trial results until written communication is received from Inspire.

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
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Results Point of Contact:

Name/Title: Saiid Davari – Associate Director, Ophthalmic Clinical Research
Organization: Inspire
phone: 919-941-9777
e-mail: sdavari@inspirepharm.com

No publications provided

Study ID Numbers:	031-408
Study First Received:	September 20, 2007
Results First Received:	January 30, 2009
Last Updated:	April 3, 2009
ClinicalTrials.gov Identifier:	NCT00534794 History of Changes
Health Authority:	United States: Institutional Review Board; United States: Food and Drug Administration