Status:
COMPLETED
Three-month Clinical Evaluation of Silicone Hydrogel Definitive 65 Contact Lenses
Lead Sponsor:
Contamac Ltd
Collaborating Sponsors:
Hartwig Research Center
Conditions:
Ametropia
Eligibility:
All Genders
18+ years
Phase:
NA
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 lens...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
January 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT02249689
Start Date
January 1 2014
End Date
May 1 2014
Last Update
August 12 2020
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Siehste
Kassel, Germany
2
Kresinsky
Würzburg, Germany