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

Not Applicable

Completed

• Conditions: Ametropia
• Interventions: Other: Definitive 74; Other: Definitive 65

• Registration Number: NCT02249689
• Lead Sponsor: Contamac Ltd

Brief Summary

Comparison of different contact lens materials.

Detailed 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.

Study Timeline

• Study Start: 2014-01
• Primary Completion: 2014-01
• Study First Submitted: 2014-01-19
• Study Completion: 2014-05
• Study First Submitted QC: 2014-09-24
• Study First Posted: 2014-09-25
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-10
• Last Update Posted: 2020-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Definitive 74	Definitive 74	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.
Definitive 65	Definitive 65	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.

Primary Outcome Measures

Name	Time	Method
questionnaire addressing subjective comfort and wear time	subjects will be followed-up for three months	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 three months	Findings were 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.
corneal staining - ocular biomicroscopy	subjects will be followed-up for three months	Findings were 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)

Siehste; 🇩🇪 Kassel, Germany

Kresinsky; 🇩🇪 Würzburg, Germany