Initial Performance of a Modified Daily Disposable Contact Lens

Refractive Error Clinical Trial

Official title:

Initial Performance of a Modified Daily Disposable Silicone Hydrogel Contact Lens

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02694835
• Other study ID #: CLP691-C001
• Status: Completed
• Phase: N/A
• Start date: March 21, 2016
• Est. completion date: April 11, 2016

Study information

• Verified date: February 2019
• 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: April 11, 2016
• Est. primary completion date: April 11, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Refractive Error
• Refractive Errors

Intervention

Device:
• Delefilcon A contact lenses with UV Absorber

• Delefilcon A contact lenses

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Results from the Novartis Clinical Trial Results Website