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Performance and Acceptance of Optive Versus Hylocomod Eyedrops in Patients With Dry Eye Symptoms

This study has been completed.
Sponsor:
Information provided by:
Allergan
ClinicalTrials.gov Identifier:
NCT00761202
First received: September 25, 2008
Last updated: January 12, 2010
Last verified: January 2010
History of Changes
  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 4

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:
  • Conjunctival Staining 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 Visual Analogue Scale [ Time Frame: week 1, month 1 ] [ Designated as safety issue: No ]
  • Comparison of Eyedrops Usage [ Time Frame: Month 1 ] [ Designated as safety issue: No ]
  • Lipid Layer Pattern Assessment [ 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
Active Comparator: 1
Optive Eyedrops
 Drug: A sterile solution containing sodium carboxymethylcellulose and glycerin, preserved with PURITE®
Eyedrops as required, but at least 3 times per day
Other Name: Optive™ Eyedrops
Active Comparator: 2
Hylocomod Eyedrops
 Drug: Sodium hyaluronate
Eyedrops as required, but at least 3 times per day
Other Name: Hylocomod

  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

No publications provided

Responsible Party: Therapeutic Area Head, Allergan, Inc.
ClinicalTrials.gov Identifier: NCT00761202     History of Changes
Other Study ID Numbers: AGN/OPH/DE/002
Study First Received: September 25, 2008
Results First Received: January 12, 2010
Last Updated: January 12, 2010
Health Authority: United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Dry Eye Syndromes
Keratoconjunctivitis Sicca
Lacrimal Apparatus Diseases
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Tetrahydrozoline
Carboxymethylcellulose Sodium
Glycerol
Hyaluronic Acid
Nasal Decongestants
Vasoconstrictor Agents
 Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Respiratory System Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Laxatives
Gastrointestinal Agents
Cryoprotective Agents
Protective Agents
Adjuvants, Immunologic
Immunologic Factors

ClinicalTrials.gov processed this record on May 16, 2013