Initial Performance of a Modified Daily Disposable Contact Lens

Not Applicable

Completed

• Conditions: Refractive Error
• Interventions: Device: Delefilcon A contact lenses; Device: Delefilcon A contact lenses with UV Absorber

• Registration Number: NCT02694835
• Lead Sponsor: Alcon Research

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-02-12
• Study First Submitted QC: 2016-02-24
• Study First Posted: 2016-03-01
• Study Start: 2016-03-21
• Primary Completion: 2016-04-11
• Study Completion: 2016-04-11
• Results First Submitted: 2019-01-22
• Results First Submitted QC: 2019-01-22
• Status Verified: 2019-02
• Results First Posted: 2019-02-15
• Last Update Submitted: 2019-02-19
• Last Update Posted: 2019-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DT1	Delefilcon A contact lenses	Delefilcon A contact lenses worn bilaterally for 9 hours
DT1 UV	Delefilcon A contact lenses with UV Absorber	Delefilcon A contact lenses with Ultraviolet (UV) Absorber worn bilaterally (in both eyes) for 9 hours

Primary Outcome Measures

Name	Time	Method
Incidence (Number) of Ocular Discomfort Device-related Adverse Events (AEs)	Day 1 at Hour 9 ± 3 hours	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.