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OpenTrials
Completed

NCT Number: NCT02694835

Initial Performance of a Modified Daily Disposable Contact Lens

The purpose of this study is to evaluate the incidence of ocular discomfort device-related adverse events with DAILIES TOTAL1® with UV Absorber (DT1 UV) contact lenses compared with current DAILIES TOTAL1® (DT1) contact lenses.

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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 an Informed Consent document;
  • Current wearers of commercial DT1 lenses (for at least 3 months), with a minimum wearing time of 5 days per week and 8 hours per day;
  • Spherical contact lens correction within the range of -2.00 to -4.00 Diopter (D) in both eyes;
  • Manifest astigmatism less than or equal to 0.75 D (at screening);
  • Best-corrected visual acuity (BCVA) greater than or equal to 20/25 in each eye (as determined by manifest refraction at screening);
  • Other protocol-specified inclusion criteria may apply.

Exclusion criteria

  • Eye injury in either eye within 12 weeks prior to study enrollment;
  • Any anterior segment infection, inflammation, disease, or abnormality that contraindicates contact lens wear as determined by the Investigator;
  • Use of systemic or ocular medications for which contact lens wear could be contraindicated, including topical ocular medications and lubrication drops that would require instillation during contact lens wear;
  • History of herpetic keratitis;
  • History of refractive surgery or irregular cornea;
  • Pathologically dry eye that precludes contact lens wear;
  • Concurrent participation (or within the previous 30 days) in a contact lens or lens care product clinical trial;
  • Monocular (only 1 eye with functional vision);
  • Other protocol-specified exclusion criteria may apply.

Treatment and study plan

Delefilcon A contact lenses with UV Absorber

Device

Other names: DAILIES TOTAL1® UV (DT1 UV)

Delefilcon A contact lenses

Device

Other names: DAILIES TOTAL1® (DT1)

Primary outcomes

  1. Incidence (Number) of Ocular Discomfort Device-related Adverse Events (AEs)

    Time frame: Day 1 at Hour 9 ± 3 hours

    An AE was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. Reported in units of eyes.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

Initial Performance of a Modified Daily Disposable Silicone Hydrogel Contact Lens

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Mar 1, 2016
Registry last updated
Mar 13, 2019

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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