NCT Number: NCT02249689
Three-month Clinical Evaluation of Silicone Hydrogel Definitive 65 Contact Lenses
Comparison of different contact lens materials.
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Siehste, Kassel, Germany
About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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)
Treatment and study plan
Definitive 74
OtherPrimary outcomes
-
questionnaire addressing subjective comfort and wear time
Time frame: 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
Time frame: 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
Time frame: 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.
Sponsors and collaborators
Lead sponsor
Contamac Ltd
Industry
Collaborators
- Hartwig Research Center
Registry information
Important dates
- Study start
- 2014
- Primary completion
- 2014
- Study completion
- 2014
- First posted
- Sep 25, 2014
- Registry last updated
- Aug 12, 2020
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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