Back to resultsThree-month Clinical Evaluation of Silicone Hydrogel Definitive 65 Contact Lenses
Primary Purpose
Ametropia
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Definitive 65
Definitive 74
Sponsored by
About this trial
This is an interventional treatment trial for Ametropia
Eligibility Criteria
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)
Sites / Locations
- Siehste
- Kresinsky
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Definitive 65
Definitive 74
Arm Description
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.
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.
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
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
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02249689
First Posted
January 19, 2014
Last Updated
August 10, 2020
Sponsor
Contamac Ltd
Collaborators
Hartwig Research Center
1. Study Identification
Unique Protocol Identification Number
NCT02249689
Brief Title
Three-month Clinical Evaluation of Silicone Hydrogel Definitive 65 Contact Lenses
Official Title
Three-month Clinical Evaluation of Silicone Hydrogel Definitive 65 Contact Lenses
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
May 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Contamac Ltd
Collaborators
Hartwig Research Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Definitive 65
Arm Type
Experimental
Arm Description
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.
Arm Title
Definitive 74
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Definitive 65
Intervention Type
Other
Intervention Name(s)
Definitive 74
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 three months
Title
limbal redness - ocular biomicroscopy
Description
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.
Time Frame
subjects will be followed-up for three months
Title
corneal staining - ocular biomicroscopy
Description
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.
Time Frame
subjects will be followed-up for three months
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 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Hartwig, PhD
Organizational Affiliation
Hartwig Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Siehste
City
Kassel
Country
Germany
Facility Name
Kresinsky
City
Würzburg
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Three-month Clinical Evaluation of Silicone Hydrogel Definitive 65 Contact Lenses
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