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

Not Applicable

Completed

• Conditions: Ametropia
• Interventions: Device: Definitive 65 HPT contact lenses; Device: Definitive 65 contact lenses

• Registration Number: NCT02312323
• Lead Sponsor: Contamac Ltd

Brief Summary

Comparison of different contact lens materials.

Detailed 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.

Study Timeline

• Study Start: 2014-11-08
• Study First Submitted: 2014-11-28
• Study First Submitted QC: 2014-12-06
• Study First Posted: 2014-12-09
• Primary Completion: 2015-05-23
• Study Completion: 2015-05-23
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-10
• Last Update Posted: 2020-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Definitive 65 HPT	Definitive 65 HPT contact lenses	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.
Definitive 65	Definitive 65 contact lenses	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.

Primary Outcome Measures

Name	Time	Method
corneal staining - ocular biomicroscopy	subjects will be followed-up for one month	Assessed using slit lamp with white light, low-medium magnification. Graded based on a grading scale which ranged from 0 to 4, where 0 is none, 1 is trace, 2 is mild, 3 is moderate and 4 is severe.
questionnaire addressing subjective comfort and wear time	subjects will be followed-up for one month	Subjects rated on a scale from 1 to 10, where 1 was 'poor' and 10 was 'excellent'.
limbal redness - ocular biomicroscopy	subjects will be followed-up for one month	Assessed using slit lamp with white light, low-medium magnification. Graded based on a grading scale which ranged from 0 to 4, where 0 is none, 1 is trace, 2 is mild, 3 is moderate and 4 is severe.
conjunctival redness - ocular biomicroscopy	subjects will be followed-up for one month	Assessed using slit lamp with white light, low-medium magnification. Graded based on a grading scale which ranged from 0 to 4, where 0 is none, 1 is trace, 2 is mild, 3 is moderate and 4 is severe.

Trial Locations

Locations (2)

Kresinky; 🇩🇪 Würzburg, Germany

Siehste; 🇩🇪 Kassel, Germany