Efficacy and Acceptability of Two Lubricant Eye Drops

This study is currently recruiting participants.

Verified by Allergan, March 2009

First Received: September 18, 2008 Last Updated: March 23, 2009 History of Changes

Sponsored by:	Allergan
Information provided by:	Allergan
ClinicalTrials.gov Identifier:	NCT00756678

Purpose

Efficacy and acceptability of two new artificial tears following two weeks of treatment in patients with dry eye. Patients will be randomized to 1 of 2 treatments for 7 days then crossover to the alternate treatment for 7 days.

Condition	Intervention	Phase
Dry Eye Syndromes	Drug: Lubricant Eye Drops (Optive®) Drug: Lubricating Eye Drops (blink® Tears)	Phase IV

Drug Information available for: Tetrahydrozoline Tetrahydrozoline hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Investigator), Crossover Assignment, Efficacy Study

Further study details as provided by Allergan:

Primary Outcome Measures:

Frequency of use [ Time Frame: Day 8, Day 16 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Comfort Assessment [ Time Frame: Baseline, Day 8, Day 16 ] [ Designated as safety issue: No ]
Acceptability Questionnaire [ Time Frame: Day 8, Day 16 ] [ Designated as safety issue: No ]
Preference Questionnaire [ Time Frame: Baseline, Day 8, Day 16 ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	September 2008
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Carboxymethylcellulose and Glycerin	Drug: Lubricant Eye Drops (Optive®) 1 drop in both eyes as needed for 7 days`
2: Active Comparator Polyethylene glycol 400	Drug: Lubricating Eye Drops (blink® Tears) 1 drop in both eyes as needed for 7 days

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Male or Female
At least 18 years of age
Current use of artificial tears

Exclusion Criteria:

Any uncontrolled systemic disease
Pregnancy or planning a pregnancy
Contact lens wear

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00756678

Contacts

Contact: Allergan Inc

clinicaltrials@allergan.com

Locations

United States, Maryland
	Recruiting
Chevy Chase, Maryland, United States

Sponsors and Collaborators

Allergan

Investigators

Study Director:

Medical Director

Allergan

More Information

No publications provided

Responsible Party:	Allergan, Inc. ( Therapeutic Area Head )
Study ID Numbers:	MA-OPT-08-001
Study First Received:	September 18, 2008
Last Updated:	March 23, 2009
ClinicalTrials.gov Identifier:	NCT00756678 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Pseudoephedrine
Oxymetazoline
Phenylephrine
Eye Diseases
Vasoconstrictor Agents
Lacrimal Apparatus Diseases

Ephedrine
Dry Eye Syndromes
Cardiovascular Agents
Peripheral Nervous System Agents
Tetrahydrozoline
Nasal Decongestants

Additional relevant MeSH terms:

Respiratory System Agents
Disease
Sympathomimetics
Eye Diseases
Physiological Effects of Drugs
Lacrimal Apparatus Diseases
Dry Eye Syndromes
Cardiovascular Agents
Tetrahydrozoline

Pharmacologic Actions
Nasal Decongestants
Pathologic Processes
Autonomic Agents
Therapeutic Uses
Syndrome
Vasoconstrictor Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on May 07, 2009