Three-month Clinical Evaluation of Silicone Hydrogel Definitive 65 Contact Lenses
Study Details
Study Description
Brief Summary
Comparison of different contact lens materials.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- 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.
Eligibility Criteria
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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Siehste | Kassel | Germany | ||
| 2 | Kresinsky | Würzburg | Germany |
Sponsors and Collaborators
- Contamac Ltd
- Hartwig Research Center
Investigators
- Principal Investigator: Andreas Hartwig, PhD, Hartwig Research Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CM-001-001