Initial Performance of a Daily Disposable Contact Lens Featuring Molded Marks

Refractive Error Clinical Trial

Official title:

Initial Performance of a Daily Disposable Contact Lens Featuring Molded Marks

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02939170
• Other study ID #: CLO870-C001
• Status: Completed
• Phase: N/A
• Start date: November 14, 2016
• Est. completion date: December 2, 2016

Study information

• Verified date: December 2017
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: December 2, 2016
• Est. primary completion date: December 2, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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;

• 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;

• 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);

• Other protocol-specified exclusion criteria may apply.

Related Conditions & MeSH terms

• Refractive Error
• Refractive Errors

Intervention

Device:
• Delefilcon A Multifocal Contact Lenses with Molded Mark

• Delefilcon A Multifocal Contact Lenses

Locations

Country	Name	City	State
United States	Contact Alcon Call Center for Trial Locations	Fort Worth	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Alcon, a Novartis Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Ocular Staining	Assessed by the Investigator through slit-lamp examination and graded on a 5-point scale, where 0=none and 4=severe. Ocular staining was categorized by corneal staining, conjunctival staining, and limbal staining. Both eyes contributed to the analysis.	Day 1 at Hour 9
Secondary	Limbal Hyperemia	Hyperemia (excess of blood) was assessed by the Investigator through slit-lamp examination and graded on a 5-point scale, where 0=none and 4=severe. Both eyes contributed to the analysis.	Day 1 at Hour 9

External Links

•   Results from the Novartis Clinical Trial Results Website