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OpenTrials
Completed

NCT Number: NCT02939170

Initial Performance of a Daily Disposable Contact Lens Featuring Molded Marks

The purpose of this study is to evaluate the impact of back surface molded marks (MM) applied to delefilcon A contact lenses as measured by the incidence of ocular discomfort device-related adverse events with DAILIES TOTAL1® Multifocal contact lenses with molded marks (DT1 MF MM) and current DAILIES TOTAL1® Multifocal contact lenses (DT1 MF).

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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

Primary location

Contact Alcon Call Center for Trial Locations

Fort Worth, Texas, 76134, United States

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 wearer of commercial DAILIES TOTAL1® contact lenses;
  • Have spectacles in current prescription available to be worn in conjunction with the investigational product;
  • Manifest astigmatism less than or equal to 0.75 diopter (D) (at screening)
  • Best corrected distance visual acuity (BCVA) greater than or equal to 20/25 in each eye;
  • 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;
  • Any use of systemic or ocular medications for which contact lens wear could be contraindicated;
  • History of herpetic keratitis, refractive surgery or irregular cornea;
  • A pathologically dry eye that precludes contact lens wear;
  • Concurrent participation in a contact lens or contact lens care product clinical trial within the previous 30 days;
  • Monocular (only 1 eye with functional vision);
  • Other protocol-specified exclusion criteria may apply.

Treatment and study plan

Delefilcon A Multifocal Contact Lenses with Molded Mark

Device

Delefilcon A multifocal contact lenses

Device

Other names: DAILIES TOTAL1® Multifocal (DT1 MF)

Primary outcomes

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

    Time frame: Day 1 at Hour 9

    An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device (test article). Ocular discomfort device-related AE was defined as an ocular AE classified as "Related" to study device and deemed to be related to ocular discomfort.

Secondary outcomes

  1. Ocular Staining

    Time frame: Day 1 at Hour 9

    Assessed by the Investigator through slit-lamp examination and graded on a 5-point scale, where 0=none and 4=severe. Ocular staining was categorized by corneal staining, conjunctival staining, and limbal staining. Both eyes contributed to the analysis.

  2. Limbal Hyperemia

    Time frame: Day 1 at Hour 9

    Hyperemia (excess of blood) was assessed by the Investigator through slit-lamp examination and graded on a 5-point scale, where 0=none and 4=severe. Both eyes contributed to the analysis.

Sponsors and collaborators

Lead sponsor

Alcon, a Novartis Company

Industry

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Oct 19, 2016
Registry last updated
Jul 2, 2018

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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