Status:
COMPLETED
One-month Clinical Evaluation of Silicone Hydrogel Definitive 65 HPT 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 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...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
November 8 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 23 2015
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT02312323
Start Date
November 8 2014
End Date
May 23 2015
Last Update
August 12 2020
Active Locations (2)
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1
Siehste
Kassel, Germany
2
Kresinky
Würzburg, Germany