Three-month Clinical Evaluation of Silicone Hydrogel Definitive 65 Contact Lenses

Contamac

Status: Completed

Conditions: Ametropia

Treatments: Other: Definitive 65; Other: Definitive 74

Study type: Interventional

Funder types: Industry

Identifiers

NCT02249689

CM-001-001

Details and patient eligibility

About

Comparison of different contact lens materials.

Full description

This will be a 3-month, open-label, bilateral, parallel-group, randomised, daily wear study. Two-thirds of the subjects will wear the Test lenses in both eyes, and one-third will wear the Control lenses in both eyes.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• willing and able to sign the informed consent form
• ages 18 years or older
• Subjects must have owned spectacles or contact lenses prior to enrolment for this trial
• spherical power between -10.00 D and +10.00 D (at vertex distance 0 mm)
• astigmatic power equal to or less than 0.75 D

Exclusion criteria

• eye injury or surgery within 3 months immediately prior to enrolment for this trial
• pre-existing ocular irritation that would preclude contact lens fitting
• currently enrolled in an ophthalmic clinical trial
• evidence of systemic or ocular abnormality, infection or disease which is likely to affect successful wear of contact lenses use of as determined by the investigator
• any use of medications for which contact lens wear could be contradicted, as determined by the investigator
• current extended-wear users (sleep-in overnight)
• current monovision leans wearers
• pregnant women and nursing mothers
• best-corrected visual acuity worse than 6/9 (logMAR: +0.20; Snellen decimal: 0.63)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

60 participants in 2 patient groups

Definitive 65

Experimental group

Description:

The Test product were the Definitive 65 (Filcon V4) lenses. This material is produced by Contamac Ltd. and the contact lenses were manufactured by Appenzeller Kontaktlinsen AG.

Treatment:

Other: Definitive 65

Definitive 74

Active Comparator group

Description:

The Control product was the commercially available Definitive 74 (Efrofilcon A) lens. This material is produced by Contamac Ltd. and the contact lenses were manufactured by Appenzeller Kontaktlinsen AG.

Treatment:

Other: Definitive 74