Status:
WITHDRAWN
Clinical Evaluation of HPT Treated Rigid Contact Lenses Made From Hexafocon A
Lead Sponsor:
Contamac Ltd
Conditions:
Ametropia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This will be an up to six months, subject-masked, contralateral, parallel-group, randomised, daily wear study. All subjects will wear the Test lens in one eye and the Control lens in the other eye. Da...
Eligibility Criteria
Inclusion
- Willing and able to sign the informed consent form
- Aged ≥18 years old
- Experienced wearer of rigid gas permeable contact lenses
- Subject's habitual contact lenses must be made of Boston XO (hexafocon A) material
- 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)
- Corneal astigmatism ≤2.00 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
- Current wearers of multifocal contact lenses
- Current wearers of toric contact lenses (front surface design)
- Current wearers of astigmatic contact lenses (posterior surface design)
- Has a reported "Strong" comfort or vision preference between each eye with their habitual RGP lenses
- Unacceptable fit of habitual lenses
- 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 :
September 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04525170
Start Date
September 1 2015
End Date
December 1 2015
Last Update
August 25 2020
Active Locations (2)
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1
Hartwig Research Center
Heikendorf, S-H, Germany, 24226
2
Siehste
Kassel, Germany