Safety, Efficacy, and Acceptability Study of an Eye Drop Formulation in Subjects With Dry Eye Disease - Full Text View

Sponsor:	Allergan
Information provided by (Responsible Party):	Allergan
ClinicalTrials.gov Identifier:	NCT01459588

Purpose

This study will evaluate the safety, efficacy, and acceptability of an eye drop formulation in subjects with dry eye disease.

Condition	Intervention	Phase
Dry Eye Syndromes	Drug: Eye Drop Formulation A Drug: Eye Drop Formulation B Drug: Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops Drug: Carboxymethylcellulose Based Lubricant Eye Drops	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Eye Diseases

Drug Information available for: Tetrahydrozoline hydrochloride Carboxymethylcellulose Sodium

U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:

Change from Baseline in Ocular Surface Disease Index© Questionnaire Score [ Time Frame: Baseline, Day 30 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Tear Break-up Time [ Time Frame: Day 30 ] [ Designated as safety issue: No ]
Corneal Staining [ Time Frame: Day 30 ] [ Designated as safety issue: No ]
Conjunctival Staining [ Time Frame: Day 30 ] [ Designated as safety issue: No ]
Schirmer Test [ Time Frame: Day 30 ] [ Designated as safety issue: No ]

Enrollment:	315
Study Start Date:	October 2011
Study Completion Date:	February 2012
Primary Completion Date:	February 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Eye Drop Formulation A Eye Drop Formulation A	Drug: Eye Drop Formulation A 1-2 drops in each eye as needed, but at least 2 times daily for 30 days
Experimental: Eye Drop Formulation B Eye Drop Formulation B	Drug: Eye Drop Formulation B 1-2 drops in each eye as needed, but at least 2 times daily for 30 days
Active Comparator: Carboxymethylcellulose Preservative-Free Lubricant Eye Drops Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops	Drug: Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops 1-2 drops in each eye as needed, but at least 2 times daily for 30 days Other Name: Optive™ Sensitive Preservative-Free Lubricant Eye Drops
Active Comparator: Carboxymethylcellulose Based Lubricant Eye Drops Carboxymethylcellulose Based Lubricant Eye Drops	Drug: Carboxymethylcellulose Based Lubricant Eye Drops 1-2 drops in each eye as needed, but at least 2 times daily for 30 days Other Name: Optive™ Lubricant Eye Drops

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Dry eyes
Current use of eye drops for dry eye at least twice daily, on average for at least 3 months

Exclusion Criteria:

Cataract, laser-assisted in situ keratomileusis (LASIK), or photorefractive keratectomy (PRK) surgery in the last 12 months
Need to wear contact lenses during the study, or has worn contact lenses in the last 6 months
Active ocular allergy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01459588

Locations

United States, California

Petaluma, California, United States

Sponsors and Collaborators

Allergan

Investigators

Study Director:

Medical Director

Allergan

More Information

No publications provided

Responsible Party:	Allergan
ClinicalTrials.gov Identifier:	NCT01459588 History of Changes
Other Study ID Numbers:	10146X-001
Study First Received:	October 24, 2011
Last Updated:	March 28, 2012
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Dry Eye Syndromes
Keratoconjunctivitis Sicca
Lacrimal Apparatus Diseases
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Carboxymethylcellulose Sodium
Tetrahydrozoline
Laxatives

Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Nasal Decongestants
Vasoconstrictor Agents
Cardiovascular Agents
Respiratory System Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2012