Initial Performance of a Daily Disposable Contact Lens Featuring Molded Marks

NCT02939170 | Completed Results

• 1 other identifier: CLO870-C001
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Refractive Error

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Ocular Staining

  Day 1 at Hour 9

• Limbal Hyperemia

  Day 1 at Hour 9

Study Arms (2)

DT1 MF MM

EXPERIMENTAL

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

DT1 MF

ACTIVE COMPARATOR

Delefilcon A multifocal contact lenses worn bilaterally for 9 hours

Device: Delefilcon A Multifocal Contact Lenses

Interventions

Delefilcon A Multifocal Contact Lenses with Molded Mark DEVICE

DT1 MF MM

Delefilcon A Multifocal Contact Lenses DEVICE

Also known as: DAILIES TOTAL1® Multifocal (DT1 MF)

DT1 MF

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 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;

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;
• 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);

Sponsors & Collaborators

• Alcon, a Novartis Company: lead

Study Sites (1)

Contact Alcon Call Center for Trial Locations

Fort Worth, Texas, 76134, United States

Location

MeSH Terms

Conditions

Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Results Point of Contact

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

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Clinical Manager, CTM

  Alcon, A Novartis Division

  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: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2016
• First Posted: October 19, 2016
• Study Start: November 14, 2016
• Primary Completion: December 2, 2016
• Study Completion: December 2, 2016
• Last Updated: July 2, 2018
• Results First Posted: January 23, 2018

Record last verified: 2017-12

Locations

US (1)