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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
234

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Drug: FID 114657 eye drops (10 ml)
Lubricating eye drop for temporary relief of burning and irritation due to dryness of the eye
Device: Habitual contact lenses
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.
Device: Habitual contact lenses
Commercially marketed biweekly or monthly replacement soft contact lenses as prescribed by eye care practitioner, brand and power
Drug: Saline control eye drops (15 ml)
Saline eye drops (15 ml)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Alcon Research

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 14, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 17, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 18, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 6, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 4, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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