Performance and Acceptance of Optive Versus Hylocomod Eyedrops in Patients With Dry Eye Symptoms - Full Text View

Sponsored by:	Allergan
Information provided by:	Allergan
ClinicalTrials.gov Identifier:	NCT00761202

Purpose

This study evaluates the performance and acceptance of Optive versus Hylocomod eyedrops, when administered for one month to patients with mild to moderate dry eye symptoms, with and without contact lenses.

Condition	Intervention	Phase
Dry Eye Syndromes	Drug: A sterile solution containing sodium carboxymethylcellulose and glycerin, preserved with PURITE® Drug: Sodium hyaluronate	Phase IV

MedlinePlus related topics: Dietary Sodium

Drug Information available for: Tetrahydrozoline Tetrahydrozoline hydrochloride Carboxymethylcellulose Hyaluronate Sodium Hyaluronic acid Glycerol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Investigator), Parallel Assignment, Safety/Efficacy Study

Further study details as provided by Allergan:

Primary Outcome Measures:

Conjunctival staining (severity and depth) by lissamine green [ Time Frame: week 1, month 1 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Corneal staining by fluorescein [ Time Frame: week 1, month 1 ] [ Designated as safety issue: No ]
Conjunctival hyperaemia [ Time Frame: week 1, month 1 ] [ Designated as safety issue: No ]
Ocular comfort and ocular symptoms on VAS scales [ Time Frame: week 1, month 1 ] [ Designated as safety issue: No ]
Comparison of eyedrops usage [ Time Frame: week 1, month 1 ] [ Designated as safety issue: No ]
Lipid layer pattern assessment via tearscope [ Time Frame: Week 1, month 1 ] [ Designated as safety issue: No ]
Aqueous thickness [ Time Frame: Week 1, month 1 ] [ Designated as safety issue: No ]

Enrollment:	64
Study Start Date:	August 2007
Study Completion Date:	June 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Optive Eyedrops	Drug: A sterile solution containing sodium carboxymethylcellulose and glycerin, preserved with PURITE® Eyedrops as required, but at least 3 times per day
2: Active Comparator Hylocomod Eyedrops	Drug: Sodium hyaluronate Eyedrops as required, but at least 3 times per day

Eligibility

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

Criteria

Inclusion Criteria:

18 years or over
Contact lens wearer, spectacle wearer or non-spectacle wearer
Mild to severe dry eye symptoms, defined as OSDI score 13 to 100
Mild to moderate conjunctival staining in each eye and/or mild to moderate corneal staining in each eye
Best corrected visual acuity of 6/9 in each eye

Exclusion Criteria:

Previously used Hylocomod or Optive eyedrops
Systemic allergy or eye allergy
Systemic disease which might have an ocular component and/or interfere with contact lens wear
Autoimmune disease which might have an ocular component and/or interfere with contact lens wear
Systemic medication which might have eye side effects and or interfere with contact lens wear
Eye infection or use of eye medication

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00761202

Locations

United Kingdom

London, United Kingdom

Sponsors and Collaborators

Allergan

Investigators

Study Director:

Medical Director

Allergan

More Information

Responsible Party:	Allergan, Inc. ( Therapeutic Area Head )
Study ID Numbers:	AGN/OPH/DE/002
Study First Received:	September 25, 2008
Last Updated:	September 26, 2008
ClinicalTrials.gov Identifier:	NCT00761202
Health Authority:	United Kingdom: Research Ethics Committee

Study placed in the following topic categories:

Pseudoephedrine
Hyaluronic Acid
Eye Diseases
Lacrimal Apparatus Diseases
Dry Eye Syndromes
Tetrahydrozoline
Naphazoline

Oxymetazoline
Glycerol
Phenylephrine
Guaifenesin
Ephedrine
Phenylpropanolamine

Additional relevant MeSH terms:

Respiratory System Agents
Disease
Immunologic Factors
Sympathomimetics
Physiological Effects of Drugs
Adjuvants, Immunologic
Cardiovascular Agents
Pharmacologic Actions

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

ClinicalTrials.gov processed this record on January 14, 2009