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Formula Identification (FID) 114657 in Contact Lens Wearers

4. oktober 2016 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

234

Fase

  • Ikke aktuelt

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Legemiddel: FID 114657 eye drops (10 ml)
Lubricating eye drop for temporary relief of burning and irritation due to dryness of the eye
Enhet: Habitual contact lenses
Commercially marketed biweekly or monthly replacement soft contact lenses as prescribed by eye care practitioner, brand and power
Aktiv komparator: 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.
Enhet: Habitual contact lenses
Commercially marketed biweekly or monthly replacement soft contact lenses as prescribed by eye care practitioner, brand and power
Legemiddel: Saline control eye drops (15 ml)
Saline eye drops (15 ml)

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Mean Pre-lens Tear Lipid Layer Thickness After 2 Hours of Lens Wear on Day 1
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Mean Comfortable Lens Wear Time (Time Uncomfortable - Time Insertion) at Baseline and Day 14
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Alcon Research

Etterforskere

  • Studieleder: Clinical Manager, Pharmaceuticals, Global Medical Affairs, Alcon Research

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. november 2014

Primær fullføring (Faktiske)

1. juli 2015

Studiet fullført (Faktiske)

1. juli 2015

Datoer for studieregistrering

Først innsendt

14. november 2014

Først innsendt som oppfylte QC-kriteriene

17. november 2014

Først lagt ut (Anslag)

18. november 2014

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

6. oktober 2016

Siste oppdatering sendt inn som oppfylte QC-kriteriene

4. oktober 2016

Sist bekreftet

1. august 2016

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • LCO242-P001

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