Initial Performance of a Modified Daily Disposable Contact Lens

Initial Performance of a Modified Daily Disposable Silicone Hydrogel 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.

Study Overview

• Status: Completed
• Conditions: Refractive Error
• Intervention / Treatment: Device: Delefilcon A contact lenses; Device: Delefilcon A contact lenses with UV Absorber

• Study Type: Interventional
• Enrollment (Actual): 81
• Phase: Not Applicable

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 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DT1 UV; Delefilcon A contact lenses with Ultraviolet (UV) Absorber worn bilaterally (in both eyes) for 9 hours	Device: Delefilcon A contact lenses with UV Absorber; Other Names: DAILIES TOTAL1® UV (DT1 UV)
Active Comparator: DT1; Delefilcon A contact lenses worn bilaterally for 9 hours	Device: Delefilcon A contact lenses; Other Names: DAILIES TOTAL1® (DT1)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence (Number) of Ocular Discomfort Device-related Adverse Events (AEs)	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.	Day 1 at Hour 9 ± 3 hours

Collaborators and Investigators

• Sponsor: Alcon Research

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2016
• Primary Completion (Actual): April 11, 2016
• Study Completion (Actual): April 11, 2016

Study Registration Dates

• First Submitted: February 12, 2016
• First Submitted That Met QC Criteria: February 24, 2016
• First Posted (Estimate): March 1, 2016

Study Record Updates

• Last Update Posted (Actual): March 13, 2019
• Last Update Submitted That Met QC Criteria: February 19, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors
• Other Study ID Numbers: CLP691-C001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes