Initial Performance of a Modified Daily Disposable Contact Lens

NCT ID: NCT02694835

Last Updated: 2019-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 81 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-21
• Study Completion Date: 2016-04-11

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

DT1 UV

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

Group Type: EXPERIMENTAL

Delefilcon A contact lenses with UV Absorber

Intervention Type: DEVICE

DT1

Delefilcon A contact lenses worn bilaterally for 9 hours

Group Type: ACTIVE_COMPARATOR

Delefilcon A contact lenses

Intervention Type: DEVICE

Interventions

Delefilcon A contact lenses with UV Absorber

Intervention Type: DEVICE

Delefilcon A contact lenses

Intervention Type: DEVICE

Other Intervention Names

DAILIES TOTAL1® UV (DT1 UV); DAILIES TOTAL1® (DT1)

Eligibility Criteria

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);

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);

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Manager, GCRA

Role: STUDY_DIRECTOR

Alcon Research

Other Identifiers

CLP691-C001

Identifier Type: -

Identifier Source: org_study_id