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Completed

NCT Number: NCT02293538

Formula Identification (FID) 114657 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.

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Key information

Conditions

Refractive Error Eye Diseases Refractive Errors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

FID 114657 eye drops (10 ml)

Drug

Lubricating eye drop for temporary relief of burning and irritation due to dryness of the eye

Saline control eye drops (15 ml)

Drug

Saline eye drops (15 ml)

Habitual Contact Lenses

Device

Commercially marketed biweekly or monthly replacement soft contact lenses as prescribed by eye care practitioner, brand and power

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

Evaluation of a Lubricant Eye Drop on Tear Lipid Layer Thickness in Contact Lens Wearers

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Nov 18, 2014
Registry last updated
Oct 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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