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

Comparison of different contact lens materials.

Study Overview

• Status: Completed
• Conditions: Ametropia
• Intervention / Treatment: Other: Definitive 65; Other: Definitive 74

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Kassel, Germany
    • Siehste
  • Würzburg, Germany
    • Kresinsky

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Definitive 65
Active Comparator: 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.	Other: Definitive 74

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
questionnaire addressing subjective comfort and wear time	Subjects rated on a scale from 1 to 10, where 1 was 'poor' and 10 was 'excellent'.	subjects will be followed-up for three months
limbal redness - ocular biomicroscopy	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.	subjects will be followed-up for three months
corneal staining - ocular biomicroscopy	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.	subjects will be followed-up for three months

Collaborators and Investigators

• Sponsor: Contamac Ltd
• Collaborators: Hartwig Research Center
• Investigators: Principal Investigator: Andreas Hartwig, PhD, Hartwig Research Center

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: January 19, 2014
• First Submitted That Met QC Criteria: September 24, 2014
• First Posted (Estimate): September 25, 2014

Study Record Updates

• Last Update Posted (Actual): August 12, 2020
• Last Update Submitted That Met QC Criteria: August 10, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors
• Other Study ID Numbers: CM-001-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No