Initial Performance of a Modified Daily Disposable Contact Lens

Alcon logo

Alcon

Status

Completed

Conditions

Refractive Error

Treatments

Device: Delefilcon A contact lenses
Device: Delefilcon A contact lenses with UV Absorber

Study type

Interventional

Funder types

Industry

Identifiers

NCT02694835
CLP691-C001

Details and patient eligibility

About

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.

Enrollment

81 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

81 participants in 2 patient groups

DT1 UV
Experimental group
Description:
Delefilcon A contact lenses with Ultraviolet (UV) Absorber worn bilaterally (in both eyes) for 9 hours
Treatment:
Device: Delefilcon A contact lenses with UV Absorber
DT1
Active Comparator group
Description:
Delefilcon A contact lenses worn bilaterally for 9 hours
Treatment:
Device: Delefilcon A contact lenses

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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