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

Primary Purpose

Dry Eye Syndromes

Status
Completed
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
A sterile solution containing sodium carboxymethylcellulose and glycerin, preserved with PURITE®
Sodium hyaluronate
Sponsored by
Allergan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye Syndromes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

Optive Eyedrops

Hylocomod Eyedrops

Outcomes

Primary Outcome Measures

Conjunctival Staining by Lissamine Green
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
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
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
Mean comfort judged on a 100 point visual analogue scale (0=Very Poor, 100=Excellent)
Daily Eyedrop Usage
Average daily eyedrop use
Lipid Layer Pattern Assessment
Lipid layer thickness as determined by lipid layer mixing pattern. A high mixing pattern = thick lipid layer.

Full Information

First Posted
September 25, 2008
Last Updated
October 25, 2013
Sponsor
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT00761202
Brief Title
Performance and Acceptance of Optive Versus Hylocomod Eyedrops in Patients With Dry Eye Symptoms
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndromes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Optive Eyedrops
Arm Title
2
Arm Type
Active Comparator
Arm Description
Hylocomod Eyedrops
Intervention Type
Drug
Intervention Name(s)
A sterile solution containing sodium carboxymethylcellulose and glycerin, preserved with PURITE®
Other Intervention Name(s)
Optive™ Eyedrops
Intervention Description
Eyedrops as required, but at least 3 times per day
Intervention Type
Drug
Intervention Name(s)
Sodium hyaluronate
Other Intervention Name(s)
Hylocomod
Intervention Description
Eyedrops as required, but at least 3 times per day
Primary Outcome Measure Information:
Title
Conjunctival Staining by Lissamine Green
Description
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)
Time Frame
week 1, month 1
Secondary Outcome Measure Information:
Title
Corneal Staining by Fluorescein
Description
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)
Time Frame
week 1, month 1
Title
Conjunctival Hyperaemia
Description
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)
Time Frame
week 1, month 1
Title
Ocular Comfort and Ocular Symptoms on Visual Analogue Scale
Description
Mean comfort judged on a 100 point visual analogue scale (0=Very Poor, 100=Excellent)
Time Frame
week 1, month 1
Title
Daily Eyedrop Usage
Description
Average daily eyedrop use
Time Frame
Month 1
Title
Lipid Layer Pattern Assessment
Description
Lipid layer thickness as determined by lipid layer mixing pattern. A high mixing pattern = thick lipid layer.
Time Frame
Week 1, month 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
City
London
Country
United Kingdom

12. IPD Sharing Statement

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

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