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

Comparison of different contact lens materials.

Study Overview

• Status: Completed
• Conditions: Ametropia
• Intervention / Treatment: Device: Definitive 65 HPT contact lenses; Device: Definitive 65 contact lenses

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 Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Kassel, Germany
    • Siehste
  • Würzburg, Germany
    • Kresinky

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 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 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 HPT; 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.	Device: Definitive 65 HPT contact lenses; Other Names: Filcon V4 (HPT)
Active Comparator: Definitive 65; 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.	Device: Definitive 65 contact lenses; Other Names: Filcon V4

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 one month
limbal redness - ocular biomicroscopy	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.	subjects will be followed-up for one month
conjunctival redness - ocular biomicroscopy	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.	subjects will be followed-up for one month
corneal staining - ocular biomicroscopy	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.	subjects will be followed-up for one month

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): November 8, 2014
• Primary Completion (Actual): May 23, 2015
• Study Completion (Actual): May 23, 2015

Study Registration Dates

• First Submitted: November 28, 2014
• First Submitted That Met QC Criteria: December 6, 2014
• First Posted (Estimate): December 9, 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-001-002