Back to resultsOne-month Clinical Evaluation of Silicone Hydrogel Definitive 65 HPT Contact Lenses
Primary Purpose
Ametropia
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Definitive 65 HPT contact lenses
Definitive 65 contact lenses
Sponsored by
About this trial
This is an interventional treatment trial for Ametropia
Eligibility Criteria
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)
Sites / Locations
- Siehste
- Kresinky
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Definitive 65 HPT
Definitive 65
Arm 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.
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.
Outcomes
Primary Outcome Measures
questionnaire addressing subjective comfort and wear time
Subjects rated on a scale from 1 to 10, where 1 was 'poor' and 10 was 'excellent'.
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02312323
First Posted
November 28, 2014
Last Updated
August 10, 2020
Sponsor
Contamac Ltd
Collaborators
Hartwig Research Center
1. Study Identification
Unique Protocol Identification Number
NCT02312323
Brief Title
One-month Clinical Evaluation of Silicone Hydrogel Definitive 65 HPT Contact Lenses
Official Title
One-month Clinical Evaluation of Silicone Hydrogel Definitive 65 HPT Contact Lenses
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
November 8, 2014 (Actual)
Primary Completion Date
May 23, 2015 (Actual)
Study Completion Date
May 23, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Contamac Ltd
Collaborators
Hartwig Research Center
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ametropia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Definitive 65 HPT
Arm Type
Experimental
Arm 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.
Arm Title
Definitive 65
Arm Type
Active Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
Definitive 65 HPT contact lenses
Other Intervention Name(s)
Filcon V4 (HPT)
Intervention Type
Device
Intervention Name(s)
Definitive 65 contact lenses
Other Intervention Name(s)
Filcon V4
Primary Outcome Measure Information:
Title
questionnaire addressing subjective comfort and wear time
Description
Subjects rated on a scale from 1 to 10, where 1 was 'poor' and 10 was 'excellent'.
Time Frame
subjects will be followed-up for one month
Title
limbal redness - ocular biomicroscopy
Description
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.
Time Frame
subjects will be followed-up for one month
Title
conjunctival redness - ocular biomicroscopy
Description
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.
Time Frame
subjects will be followed-up for one month
Title
corneal staining - ocular biomicroscopy
Description
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.
Time Frame
subjects will be followed-up for one month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Hartwig, PhD, FAAO
Organizational Affiliation
Hartwig Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Siehste
City
Kassel
Country
Germany
Facility Name
Kresinky
City
Würzburg
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
One-month Clinical Evaluation of Silicone Hydrogel Definitive 65 HPT Contact Lenses
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