- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04525170
Clinical Evaluation of HPT Treated Rigid Contact Lenses Made From Hexafocon A
August 20, 2020 updated by: Contamac Ltd
Clinical Evaluation of Hydra-PEG (Polyethylene Glycol) Treatment (HPT) Treated Rigid Contact Lenses Made From Hexafocon A
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.
Data from the first four weeks of Test and Control lens exposure will be used for the FDA 510 (k) submission.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Kassel, Germany
- Siehste
-
-
S-H
-
Heikendorf, S-H, Germany, 24226
- Hartwig Research Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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 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 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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: HPT treated
daily wear Hexafocon A rigid contact lens treated with Hydra PEG surface coating
|
Other Names:
|
Experimental: untreated
daily wear Hexafocon A rigid contact lens
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
questionnaire addressing subjective comfort and wear time
Time Frame: subjects will be followed-up for one month
|
Subjects rated on a scale from 1 to 10, where 1 was 'poor' and 10 was 'excellent'.
|
subjects will be followed-up for one month
|
limbal redness - ocular biomicroscopy
Time Frame: subjects will be followed-up for one month
|
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.
|
subjects will be followed-up for one month
|
corneal staining - ocular biomicroscopy
Time Frame: subjects will be followed-up for one month
|
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.
|
subjects will be followed-up for one month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Andreas Hartwig, PhD, Hartwig Research Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2015
Primary Completion (Actual)
December 1, 2015
Study Completion (Actual)
December 1, 2015
Study Registration Dates
First Submitted
October 2, 2015
First Submitted That Met QC Criteria
August 20, 2020
First Posted (Actual)
August 25, 2020
Study Record Updates
Last Update Posted (Actual)
August 25, 2020
Last Update Submitted That Met QC Criteria
August 20, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CM-002-002
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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