DAILIES TOTAL1® Lubricity Post Wear

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Alcon

Status

Completed

Conditions

Refractive Error

Treatments

Device: Delefilcon A contact lenses

Study type

Interventional

Funder types

Industry

Identifiers

NCT02072980
M-14-002

Details and patient eligibility

About

The primary objective of the study is to demonstrate that the lubricity of DAILIES TOTAL1® (DT1) lenses after 16 hours of wear is equivalent to the lubricity of unworn DT1 lenses.

Full description

In this study, participants wore study lenses for 2 specified time periods (16 hours and 15 minutes, treatment sequence randomized) following which lenses were collected for ex vivo lubricity analysis. The ex vivo lubricity analysis was evaluated under a separate non-clinical protocol.

Enrollment

15 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Willing and able to sign Informed Consent document.
  • Adapted, current soft contact lens wearer.
  • Requires contact lens powers within the specified range of -0.50 diopters (D) to -10.00D.
  • Cylinder between 0.00D and -1.00D (inclusive) in both eyes at Visit 1 manifest refraction.
  • Vision correctable to 20/25 or better in each eye at distance with study lenses.
  • Willing to wear study lenses at least 16 waking hours in one day and attend all study visits.
  • Able to be successfully fitted with study lenses.
  • Other protocol-specified inclusion criteria may apply.

Exclusion criteria

  • Any ocular infection, inflammation, abnormality or active disease that would contraindicate contact lens wear, as determined by the Investigator.
  • Use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator.
  • Use of artificial tears and rewetting drops during the study.
  • Monocular (only one eye with functional vision) or fit with only one lens.
  • Any abnormal ocular condition observed during the Visit 1 slit lamp examination.
  • History of herpetic keratitis, ocular surgery, or irregular cornea.
  • Pregnant.
  • Participation in any clinical study within 30 days of Visit 1.
  • Other protocol-specified exclusion criteria may apply.

Trial design

15 participants in 2 patient groups

16hrs/15mins
Other group
Description:
Delefilcon A contact lenses worn bilaterally (in both eyes) for 16 waking hours (1 day) in Period 1, followed by 15 minutes in Period 2. A fresh pair of lenses was dispensed for Period 2.
Treatment:
Device: Delefilcon A contact lenses
15mins/16hrs
Other group
Description:
Delefilcon A contact lenses worn bilaterally for 15 minutes in Period 1, followed by 16 waking hours (1 day) in Period 2. A fresh pair of lenses was dispensed for Period 2.
Treatment:
Device: Delefilcon A contact lenses

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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