Back to resultsEfficacy Study of a New Eyedrop on Silicone Hydrogel Contact Lens Wearers With Dry Eye Complaints
Primary Purpose
Contact Lens Related Dry Eye Syndrome
Status
Completed
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
OPTIVEtm Plus
No treatment
Blink Contacts® Eye Drops
Sponsored by
About this trial
This is an interventional treatment trial for Contact Lens Related Dry Eye Syndrome
Eligibility Criteria
Inclusion criteria:
- Current silicone hydrogel contact lens wearer
- Complaints of contact lens related dry eye (Symptoms and reduced comfortable wearing time)
Exclusion criteria:
- Known allergy or sensitivity to the study product(s) or its components
- Systemic or ocular allergies
- Use of systemic medication which might have ocular side effects.
- Any ocular infection.
- Use of ocular medication.
- Significant ocular tissue anomaly
Sites / Locations
- OTG Research & Consultancy
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Placebo Comparator
Active Comparator
Arm Label
New study eye drop
No Eyedrop
BLINK Contacts Lubricating eye drop
Arm Description
One month of contact lens wear with use of the Test study eye drops
One month of contact lens wear with no eye drop use
One month of contact lens wear with use of the Control study eye drops
Outcomes
Primary Outcome Measures
Tear Break up Time
Secondary Outcome Measures
Conjunctival staining measurement
Tear film evaporation rate
Ocular Surface Disease Index questionnaire
Comfort, vision and ocular symptoms questionnaire
Post wear contact lens deposition and lipid uptake assessment
Full Information
NCT ID
NCT01543061
First Posted
February 22, 2012
Last Updated
September 26, 2013
Sponsor
Optometric Technology Group Ltd
Collaborators
Allergan
1. Study Identification
Unique Protocol Identification Number
NCT01543061
Brief Title
Efficacy Study of a New Eyedrop on Silicone Hydrogel Contact Lens Wearers With Dry Eye Complaints
Official Title
Evaluation of the Effect of Repeated Usage of a New Eyedrop on Silicone Hydrogel Contact Lens Wearers With Dry Eye Complaints
Study Type
Interventional
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Optometric Technology Group Ltd
Collaborators
Allergan
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objectives of the investigation will be to assess the effect of the repeated usage of a new eye drop on the tear film characteristics of silicone hydrogel contact lens wearers with contact lens related comfort problems and to quantify any potential benefit.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Contact Lens Related Dry Eye Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
35 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
New study eye drop
Arm Type
Active Comparator
Arm Description
One month of contact lens wear with use of the Test study eye drops
Arm Title
No Eyedrop
Arm Type
Placebo Comparator
Arm Description
One month of contact lens wear with no eye drop use
Arm Title
BLINK Contacts Lubricating eye drop
Arm Type
Active Comparator
Arm Description
One month of contact lens wear with use of the Control study eye drops
Intervention Type
Device
Intervention Name(s)
OPTIVEtm Plus
Intervention Description
1 drop in each eye four times a day for a period of 30 (± 3) days
Intervention Type
Procedure
Intervention Name(s)
No treatment
Intervention Description
One month of contact lens wear with no eye drop use
Intervention Type
Device
Intervention Name(s)
Blink Contacts® Eye Drops
Other Intervention Name(s)
Blink Contacts®
Intervention Description
1 drop in each eye four times a day for a period of 30 (± 3) days
Primary Outcome Measure Information:
Title
Tear Break up Time
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Conjunctival staining measurement
Time Frame
30 days
Title
Tear film evaporation rate
Time Frame
30 days
Title
Ocular Surface Disease Index questionnaire
Time Frame
30 days
Title
Comfort, vision and ocular symptoms questionnaire
Time Frame
30 days
Title
Post wear contact lens deposition and lipid uptake assessment
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
Current silicone hydrogel contact lens wearer
Complaints of contact lens related dry eye (Symptoms and reduced comfortable wearing time)
Exclusion criteria:
Known allergy or sensitivity to the study product(s) or its components
Systemic or ocular allergies
Use of systemic medication which might have ocular side effects.
Any ocular infection.
Use of ocular medication.
Significant ocular tissue anomaly
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michel Guillon, PhD
Organizational Affiliation
Optometric Technology Group Ltd
Official's Role
Principal Investigator
Facility Information:
Facility Name
OTG Research & Consultancy
City
London
ZIP/Postal Code
SW1E 6AU
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Efficacy Study of a New Eyedrop on Silicone Hydrogel Contact Lens Wearers With Dry Eye Complaints
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