One-month Clinical Evaluation of Silicone Hydrogel Definitive 65 HPT Contact Lenses

Contamac

Status: Completed

Conditions: Ametropia

Treatments: Device: Definitive 65 contact lenses; Device: Definitive 65 HPT contact lenses

Study type: Interventional

Funder types: Industry

Identifiers

NCT02312323

CM-001-002

Details and patient eligibility

About

Comparison of different contact lens materials.

Full description

This is a 1-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: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• willing and able to sign 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 ≤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 or use of the accessory solutions, 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 lens 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)

---

35 participants in 2 patient groups

Definitive 65 HPT

Experimental group

Description:

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

Treatment:

Device: Definitive 65 HPT contact lenses

Definitive 65

Active Comparator group

Description:

The Control product was the commercially available Definitive 65 (Efrofilcon A) lens. This material is produced by Contamac Ltd. and the contact lenses were manufactured by Appenzeller Kontaktlinsen AG.

Treatment:

Device: Definitive 65 contact lenses