Performance and Acceptance of Optive Versus Hylocomod Eyedrops in Patients With Dry Eye Symptoms
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Aug 2007
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
September 25, 2008
CompletedFirst Posted
Study publicly available on registry
September 29, 2008
CompletedResults Posted
Study results publicly available
February 4, 2010
CompletedNovember 19, 2013
October 1, 2013
10 months
September 25, 2008
January 12, 2010
October 25, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
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)
week 1, month 1
Secondary Outcomes (5)
Corneal Staining by Fluorescein
week 1, month 1
Conjunctival Hyperaemia
week 1, month 1
Ocular Comfort and Ocular Symptoms on Visual Analogue Scale
week 1, month 1
Daily Eyedrop Usage
Month 1
Lipid Layer Pattern Assessment
Week 1, month 1
Study Arms (2)
1
ACTIVE COMPARATOROptive Eyedrops
2
ACTIVE COMPARATORHylocomod Eyedrops
Interventions
Eyedrops as required, but at least 3 times per day
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (1)
Unknown Facility
London, London, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Vice President Medical Affairs - Europe
- Organization
- Allergan, Inc.
Study Officials
- STUDY DIRECTOR
Medical Director
Allergan
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 25, 2008
First Posted
September 29, 2008
Study Start
August 1, 2007
Primary Completion
June 1, 2008
Study Completion
June 1, 2008
Last Updated
November 19, 2013
Results First Posted
February 4, 2010
Record last verified: 2013-10