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).

Study Overview

• Status: Completed
• Conditions: Refractive Error
• Intervention / Treatment: Device: Delefilcon A Multifocal Contact Lenses with Molded Mark; Device: Delefilcon A Multifocal Contact Lenses

• Study Type: Interventional
• Enrollment (Actual): 87
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Fort Worth, Texas, United States, 76134
      • Contact Alcon Call Center for Trial Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: DAILIES TOTAL1® Multifocal (DT1 MF)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Ocular Discomfort Device-related Adverse Events (AE)	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.	Day 1 at Hour 9

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ocular Staining	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.	Day 1 at Hour 9
Limbal Hyperemia	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.	Day 1 at Hour 9

Collaborators and Investigators

• Sponsor: Alcon, a Novartis Company
• Investigators: Study Director: Clinical Manager, CTM, Alcon, A Novartis Division

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2016
• Primary Completion (Actual): December 2, 2016
• Study Completion (Actual): December 2, 2016

Study Registration Dates

• First Submitted: October 18, 2016
• First Submitted That Met QC Criteria: October 18, 2016
• First Posted (Estimate): October 19, 2016

Study Record Updates

• Last Update Posted (Actual): July 2, 2018
• Last Update Submitted That Met QC Criteria: May 31, 2018
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors
• Other Study ID Numbers: CLO870-C001