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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

September 25, 2008
September 29, 2008
January 12, 2010
February 4, 2010
November 19, 2013
August 2007
June 2008   (Final data collection date for primary outcome measure)
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)
Conjunctival staining (severity and depth) by lissamine green [ Time Frame: week 1, month 1 ]
Complete list of historical versions of study NCT00761202 on ClinicalTrials.gov Archive Site
  • 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)
  • 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)
  • 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)
  • Daily Eyedrop Usage [ Time Frame: Month 1 ]
    Average daily eyedrop use
  • 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.
  • Corneal Staining by Fluorescein [ Time Frame: week 1, month 1 ]
  • Conjunctival Hyperaemia [ Time Frame: week 1, month 1 ]
  • Ocular comfort and ocular symptoms on VAS scales [ Time Frame: week 1, month 1 ]
  • Comparison of Eyedrops Usage [ Time Frame: week 1, month 1 ]
  • Lipid layer pattern assessment via tearscope [ Time Frame: Week 1, month 1 ]
  • Aqueous thickness [ Time Frame: Week 1, month 1 ]
Not Provided
Not Provided
 
Performance and Acceptance of Optive Versus Hylocomod Eyedrops in Patients With Dry Eye Symptoms
Not Provided
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Dry Eye Syndromes
  • 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
  • Drug: Sodium hyaluronate
    Eyedrops as required, but at least 3 times per day
    Other Name: Hylocomod
  • Active Comparator: 1
    Optive Eyedrops
    Intervention: Drug: A sterile solution containing sodium carboxymethylcellulose and glycerin, preserved with PURITE®
  • Active Comparator: 2
    Hylocomod Eyedrops
    Intervention: Drug: Sodium hyaluronate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
64
June 2008
June 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT00761202
AGN/OPH/DE/002
No
Not Provided
Not Provided
Allergan
Allergan
Not Provided
Study Director: Medical Director Allergan
Allergan
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP