An interventional study of Definitive 65 HPT contact lenses and Definitive 65 contact lenses in Ametropia, sponsored by Contamac Ltd. Completed at 2 sites in Germany. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-08-12.
Sponsored by Contamac Ltd · Not applicable, Interventional, and Treatment
Comparison of different contact lens materials.
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 both eyes.
413 studies on the registry are indexed under Refractive Errors; 62 are open to participants now.
This study's enrollment of 35 is below the median of 82 across 296 interventional studies indexed under Refractive Errors.
Browse Refractive Errors studies →Contamac Ltd is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The Test product were the Definitive 65 (Filcon V4) lenses with Hydra PEG surface coating. This material is produced by Contamac Ltd. and the contact lenses were manufactured by Appenzeller Kontaktlinsen AG.
Device: Definitive 65 HPT contact lenses
The Control product was the commercially available Definitive 65 (Efrofilcon A) lens. This material is produced by Contamac Ltd. and the contact lenses were manufactured by Appenzeller Kontaktlinsen AG.
Device: Definitive 65 contact lenses
Also known as: Filcon V4 (HPT)
Also known as: Filcon V4
questionnaire addressing subjective comfort and wear time
Subjects rated on a scale from 1 to 10, where 1 was 'poor' and 10 was 'excellent'.
Time frame: subjects will be followed-up for one month
limbal redness - ocular biomicroscopy
Assessed using slit lamp with white light, low-medium magnification. 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.
Time frame: subjects will be followed-up for one month
conjunctival redness - ocular biomicroscopy
Assessed using slit lamp with white light, low-medium magnification. 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.
Time frame: subjects will be followed-up for one month
corneal staining - ocular biomicroscopy
Assessed using slit lamp with white light, low-medium magnification. 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.
Time frame: subjects will be followed-up for one month
This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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Contamac Ltd