Performance Evaluation of DAILIES® TOTAL1™ in First Time Contact Lens Wearers

Alcon

Status: Completed

Conditions: Myopia

Treatments: Device: Delefilcon A contact lens

Study type: Interventional

Funder types: Industry

Identifiers

NCT01494545

P-347-C-016

Details and patient eligibility

About

The purpose of this study was to evaluate the performance of DAILIES® TOTAL1™ in first time contact lens wearers.

Enrollment: 102 patients

Sex: All

Ages: 18 to 44 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Sign Informed Consent.
• No previous contact lens experience or attempt to try contact lenses (neophyte).
• Willing to wear study lenses for at least 8 hours a day for at least 5 days a week.
• Use spectacle lenses for vision correction.
• Other protocol-defined inclusion criteria may apply.

Exclusion criteria

• 45 years or older.
• Prior wear experience with rigid or soft contact lenses.
• Systemic or ocular disease or disorder that would negatively affect the conduct or outcome of the study.
• History of ocular surgery/trauma within the last six months.
• Pregnant or nursing women.
• Participation in any other ophthalmic drug or device clinical trial within 30 days of enrollment.
• Other protocol-defined exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

102 participants in 1 patient group

Delefilcon A

Experimental group

Description:

Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.

Treatment:

Device: Delefilcon A contact lens