- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02293538
Formula Identification (FID) 114657 in Contact Lens Wearers
October 4, 2016 updated by: Alcon Research
Evaluation of a Lubricant Eye Drop on Tear Lipid Layer Thickness in Contact Lens Wearers
The purpose of this study is to evaluate the thickness of the pre-lens tear lipid layer after 2 hours of lens wear with use of FID 114657 compared to saline control.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
234
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Must sign the informed consent form.
- Stable, tear lipid layer thickness ≤ 75 nm without contact lenses.
- Successfully wearing bi-weekly or monthly replacement soft contact lenses in both eyes for a minimum of 5 days/week during the past 2 months prior to Visit 1.
- Vision correctable to 20/25 Snellen (feet) or better at distance with habitual contact lenses at Visit 1.
- Willing to wear lenses 5 days a week, 8 hours a day for at least 2 days during the study.
- Demonstrate symptoms of contact lens discomfort.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- Routinely sleeping in lenses.
- Any active eye inflammation or condition that contraindicates contact lens wear.
- Any systemic diseases that could prevent successful contact lens wear.
- Use of systemic or ocular medications that contraindicate lens wear.
- Fit with only 1 contact lens.
- Unwilling to discontinue the use of cosmetics (such as eyeliner, mascara, or eye shadow) or facial creams on or around the eyelids on Day 1 and Day 14 of the study.
- Women of childbearing potential who are currently pregnant, test positive for pregnancy at Screening visit, breast feeding, or unwilling to use adequate birth control throughout the study.
- Other protocol-defined exclusion criteria may apply.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: FID 114657
FID 114657 eye drops (10 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks.
|
Lubricating eye drop for temporary relief of burning and irritation due to dryness of the eye
Commercially marketed biweekly or monthly replacement soft contact lenses as prescribed by eye care practitioner, brand and power
|
Active Comparator: Saline Control
Saline control eye drops (15 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks.
|
Commercially marketed biweekly or monthly replacement soft contact lenses as prescribed by eye care practitioner, brand and power
Saline eye drops (15 ml)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Pre-lens Tear Lipid Layer Thickness After 2 Hours of Lens Wear on Day 1
Time Frame: Day 1, after 2 hours of lens wear
|
The pre-lens tear film is the layer of tears located on top of the contact lens (i.e., between the eye lid and the contact lens).
The anterior-most layer of the pre-lens tear film consists of lipids.
Lipid layer thickness (LLT) is measured with the LipiView® Interferometer.
LLT is measured in interferometric color units (ICUs), where 1 ICU reflects about 1 nanometer (nm) lipid layer thickness.
Higher values of LLT indicate a better lubrication of the ocular surface.
A thicker tear lipid layer helps reduce evaporation and is indicative of a more stable tear film.
The right eye only was used for this measure.
|
Day 1, after 2 hours of lens wear
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Comfortable Lens Wear Time (Time Uncomfortable - Time Insertion) at Baseline and Day 14
Time Frame: Baseline (Day 0), Day 14
|
At Baseline and on Day 14, comfort was collected through participant questionnaires regarding average and comfortable wear time.
Participants filled in what time of day (over the past three days) they usually inserted their lenses, removed them, and at what time they usually became uncomfortable, or if they remained comfortable all day.
Comfortable wear time was calculated as Time Uncomfortable minus Time Insertion.
The participant rated both eyes together by providing one single rating.
This outcome measure was prespecified for only FID 114657.
|
Baseline (Day 0), Day 14
|
Percentage of Participants That Experienced At Least 1 Unit Increase From Baseline Score to Day 14 for Overall Comfort With Lenses
Time Frame: Baseline (Day 0), Day 14
|
Overall comfort was rated by the participant on a 10-point scale, where 1=Poor and 10=Excellent, at Day 0 for their habitual lenses and at Day 14 for the lenses worn for the study during use of the assigned drop regimen.
A 1-unit increase indicates improvement.
The participant rated both eyes together by providing one single rating.
|
Baseline (Day 0), Day 14
|
Mean Change From Baseline in Comfortable Lens Wear Time (Time Uncomfortable - Time Insertion) to Day 14
Time Frame: Baseline (Day 0), Day 14
|
At Baseline and on Day 14, comfort was collected through participant questionnaires regarding average and comfortable wear time.
Participants filled in what time of day (over the past three days) they usually inserted their lenses, removed them, and at what time they usually became uncomfortable, or if they remained comfortable all day.
Comfortable wear time was calculated as Time Uncomfortable minus Time Insertion.
A positive change from Baseline indicates improvement.
The participant rated both eyes together by providing one single rating.
|
Baseline (Day 0), Day 14
|
Mean Pre-lens Tear Lipid Layer Thickness After 2 Hours of Lens Wear on Day 14
Time Frame: Day 14, after 2 hours of lens wear
|
The pre-lens tear film is the layer of tears located on top of the contact lens (i.e., between the eye lid and the contact lens).
The anterior-most layer of the pre-lens tear film consists of lipids.
Lipid layer thickness (LLT) is measured with the LipiView® Interferometer.
LLT is measured in interferometric color units (ICUs), where 1 ICU reflects about 1 nanometer (nm) lipid layer thickness.
Higher values of LLT indicate a better lubrication of the ocular surface.
A thicker tear lipid layer helps reduce evaporation and is indicative of a more stable tear film.
The right eye only was used for this measure.
|
Day 14, after 2 hours of lens wear
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Clinical Manager, Pharmaceuticals, Global Medical Affairs, Alcon Research
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2014
Primary Completion (Actual)
July 1, 2015
Study Completion (Actual)
July 1, 2015
Study Registration Dates
First Submitted
November 14, 2014
First Submitted That Met QC Criteria
November 17, 2014
First Posted (Estimate)
November 18, 2014
Study Record Updates
Last Update Posted (Estimate)
October 6, 2016
Last Update Submitted That Met QC Criteria
October 4, 2016
Last Verified
August 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LCO242-P001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Refractive Error
-
Alcon ResearchCompletedRefractive Error - Myopia Severe | Refractive Error - Myopia SimpleUnited States, Ireland, Singapore
-
Vision Service PlanCompletedRefractive Error - Myopia BilateralUnited States
-
Johnson & Johnson Vision Care, Inc.TerminatedRefractive Error CorrectionUnited States
-
Vision Service PlanCompletedRefractive Error - Myopia BilateralUnited States
-
Wang HongxiaTianjin Eye HospitalCompletedRefractive Error - Myopia AxialChina
-
Tianjin Eye HospitalRecruitingMyopia; Refractive ErrorChina
-
Abbott Medical OpticsCompletedStable Myopic Refractive Error, With or Without AstigmatismUnited States
-
KK Women's and Children's HospitalWithdrawnRefractive Error - Myopia
-
Alcon ResearchCompletedRefractive ErrorsUnited States
-
Alcon ResearchCompletedRefractive ErrorsUnited States
Clinical Trials on FID 114657 eye drops (10 ml)
-
Alcon ResearchCompleted
-
Alcon ResearchCompleted
-
Alcon ResearchCompleted
-
Merz Pharmaceuticals GmbHCompletedHealthy Volunteers and Glaucoma PatientsGermany
-
Alcon ResearchCompleted