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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT00761202
First received: September 25, 2008
Last updated: October 25, 2013
Last verified: October 2013
  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:


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 ]
    Percentage of cases of limbal staining by lissamine green at each point on a five point scale (0 = None, 1 = Trace, 2 = Mild, 3 = Moderate, 4 = Severe)


Secondary Outcome Measures:
  • Corneal Staining by Fluorescein [ Time Frame: week 1, month 1 ] [ Designated as safety issue: No ]
    Percentage of cases of limbal staining by sodium fluorescein at each point on a five point scale (0 = None, 1 = Trace, 2 = Mild, 3 = Moderate, 4 = Severe)

  • Conjunctival Hyperaemia [ Time Frame: week 1, month 1 ] [ Designated as safety issue: No ]
    Percentage of conjunctival response reported in terms of limbal hyperaemia for the worst responses over the area at each point on a five point scale (0=clear/white conjunctiva, 1=slight redness, 2=Mild redness, 3=Moderate redness, 4=Severe redness)

  • Ocular Comfort and Ocular Symptoms on Visual Analogue Scale [ Time Frame: week 1, month 1 ] [ Designated as safety issue: No ]
    Mean comfort judged on a 100 point visual analogue scale (0=Very Poor, 100=Excellent)

  • Daily Eyedrop Usage [ Time Frame: Month 1 ] [ Designated as safety issue: No ]
    Average daily eyedrop use

  • Lipid Layer Pattern Assessment [ Time Frame: Week 1, month 1 ] [ Designated as safety issue: No ]
    Lipid layer thickness as determined by lipid layer mixing pattern. A high mixing pattern = thick lipid layer.


Enrollment: 50
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Allergan
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: October 25, 2013
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
Ophthalmic Solutions
Carboxymethylcellulose Sodium
Glycerol
Hyaluronic Acid
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nasal Decongestants
Vasoconstrictor Agents
Cardiovascular Agents
Respiratory System Agents
Laxatives
Gastrointestinal Agents
Cryoprotective Agents
Protective Agents
Adjuvants, Immunologic

ClinicalTrials.gov processed this record on July 31, 2014