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Initial Performance of a Daily Disposable Contact Lens Featuring Molded Marks

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ClinicalTrials.gov Identifier: NCT02939170
Recruitment Status : Completed
First Posted : October 19, 2016
Results First Posted : January 23, 2018
Last Update Posted : July 2, 2018
Sponsor:
Information provided by (Responsible Party):
Alcon Research ( Alcon, a Novartis Company )

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Refractive Error Device: Delefilcon A Multifocal Contact Lenses with Molded Mark Device: Delefilcon A Multifocal Contact Lenses Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 87 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Initial Performance of a Daily Disposable Contact Lens Featuring Molded Marks
Actual Study Start Date : November 14, 2016
Actual Primary Completion Date : December 2, 2016
Actual Study Completion Date : December 2, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: DT1 MF MM
Delefilcon A multifocal contact lenses with molded marks on back surface worn bilaterally (in both eyes) for 9 hours
Device: Delefilcon A Multifocal Contact Lenses with Molded Mark
Active Comparator: DT1 MF
Delefilcon A multifocal contact lenses worn bilaterally for 9 hours
Device: Delefilcon A Multifocal Contact Lenses
Other Name: DAILIES TOTAL1® Multifocal (DT1 MF)




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02939170


Locations
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United States, Texas
Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon, a Novartis Company
Investigators
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Study Director: Clinical Manager, CTM Alcon, A Novartis Division

Additional Information:
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Responsible Party: Alcon, a Novartis Company
ClinicalTrials.gov Identifier: NCT02939170     History of Changes
Other Study ID Numbers: CLO870-C001
First Posted: October 19, 2016    Key Record Dates
Results First Posted: January 23, 2018
Last Update Posted: July 2, 2018
Last Verified: December 2017

Additional relevant MeSH terms:
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Refractive Errors
Eye Diseases