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

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ClinicalTrials.gov Identifier: NCT00761202
Recruitment Status : Completed
First Posted : September 29, 2008
Results First Posted : February 4, 2010
Last Update Posted : November 19, 2013
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Dry Eye Syndromes Drug: A sterile solution containing sodium carboxymethylcellulose and glycerin, preserved with PURITE® Drug: Sodium hyaluronate Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Study Start Date : August 2007
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Conjunctival Staining by Lissamine Green [ Time Frame: week 1, month 1 ]
    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 :
  1. Corneal Staining by Fluorescein [ Time Frame: week 1, month 1 ]
    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)

  2. Conjunctival Hyperaemia [ Time Frame: week 1, month 1 ]
    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)

  3. Ocular Comfort and Ocular Symptoms on Visual Analogue Scale [ Time Frame: week 1, month 1 ]
    Mean comfort judged on a 100 point visual analogue scale (0=Very Poor, 100=Excellent)

  4. Daily Eyedrop Usage [ Time Frame: Month 1 ]
    Average daily eyedrop use

  5. Lipid Layer Pattern Assessment [ Time Frame: Week 1, month 1 ]
    Lipid layer thickness as determined by lipid layer mixing pattern. A high mixing pattern = thick lipid layer.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00761202


Locations
United Kingdom
London, United Kingdom
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
More Information
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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00761202     History of Changes
Other Study ID Numbers: AGN/OPH/DE/002
First Posted: September 29, 2008    Key Record Dates
Results First Posted: February 4, 2010
Last Update Posted: November 19, 2013
Last Verified: October 2013

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Hyaluronic Acid
Ophthalmic Solutions
Tetrahydrozoline
Carboxymethylcellulose Sodium
Adjuvants, Immunologic
 Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents
Pharmaceutical Solutions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Nasal Decongestants
Vasoconstrictor Agents
Respiratory System Agents
Laxatives
Gastrointestinal Agents