Efficacy Study of a New Eyedrop on Silicone Hydrogel Contact Lens Wearers With Dry Eye Complaints
Evaluation of the Effect of Repeated Usage of a New Eyedrop on Silicone Hydrogel Contact Lens Wearers With Dry Eye Complaints
1 other identifier
interventional
35
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Feb 2012
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
February 1, 2012
CompletedFirst Submitted
Initial submission to the registry
February 22, 2012
CompletedFirst Posted
Study publicly available on registry
March 2, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedSeptember 27, 2013
September 1, 2013
7 months
February 22, 2012
September 26, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Tear Break up Time
30 days
Secondary Outcomes (5)
Conjunctival staining measurement
30 days
Tear film evaporation rate
30 days
Ocular Surface Disease Index questionnaire
30 days
Comfort, vision and ocular symptoms questionnaire
30 days
Post wear contact lens deposition and lipid uptake assessment
30 days
Study Arms (3)
New study eye drop
ACTIVE COMPARATOROne month of contact lens wear with use of the Test study eye drops
No Eyedrop
PLACEBO COMPARATOROne month of contact lens wear with no eye drop use
BLINK Contacts Lubricating eye drop
ACTIVE COMPARATOROne month of contact lens wear with use of the Control study eye drops
Interventions
1 drop in each eye four times a day for a period of 30 (± 3) days
1 drop in each eye four times a day for a period of 30 (± 3) days
Eligibility Criteria
You may qualify if:
- Current silicone hydrogel contact lens wearer
- Complaints of contact lens related dry eye (Symptoms and reduced comfortable wearing time)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Optometric Technology Group Ltdlead
- Allergancollaborator
Study Sites (1)
OTG Research & Consultancy
London, SW1E 6AU, United Kingdom
Study Officials
- PRINCIPAL INVESTIGATOR
Michel Guillon, PhD
Optometric Technology Group Ltd
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 22, 2012
First Posted
March 2, 2012
Study Start
February 1, 2012
Primary Completion
September 1, 2012
Study Completion
December 1, 2012
Last Updated
September 27, 2013
Record last verified: 2013-09