Initial Performance of a Modified Daily Disposable Contact Lens

NCT02694835 | Completed Results FDA Device

• 1 other identifier: CLP691-C001
• Study Type: interventional
• Target: 81
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Refractive Error

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

DT1 UV

EXPERIMENTAL

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

Device: Delefilcon A contact lenses with UV Absorber

DT1

ACTIVE COMPARATOR

Delefilcon A contact lenses worn bilaterally for 9 hours

Device: Delefilcon A contact lenses

Interventions

Delefilcon A contact lenses with UV Absorber DEVICE

Also known as: DAILIES TOTAL1® UV (DT1 UV)

DT1 UV

Delefilcon A contact lenses DEVICE

Also known as: DAILIES TOTAL1® (DT1)

DT1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);

You may not qualify if:

• 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);

Sponsors & Collaborators

• Alcon Research: lead

MeSH Terms

Conditions

Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Results Point of Contact

• Title: Clinical Project Lead, Vision Care
• Organization: Alcon, A Novartis Division

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Clinical Manager, GCRA

  Alcon Research

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2016
• First Posted: March 1, 2016
• Study Start: March 21, 2016
• Primary Completion: April 11, 2016
• Study Completion: April 11, 2016
• Last Updated: March 13, 2019
• Results First Posted: February 15, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share