One-month Clinical Evaluation of Silicone Hydrogel Definitive 65 HPT Contact Lenses

Study Overview
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Brief Summary
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Comparison of different contact lens materials.

Detailed Description
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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.

Official Title
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One-month Clinical Evaluation of Silicone Hydrogel Definitive 65 HPT Contact Lenses

Conditions
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Ametropia

Intervention / Treatment
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* Device: Definitive 65 HPT contact lenses
* Device: Definitive 65 contact lenses


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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 Pregnant women and nursing mothers Best-corrected visual acuity worse than 6/9 (LogMAR: +0.20; Snellen decimal: 0.63)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Definitive 65 HPT<br>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<br> <br> * Other names: Filcon V4 (HPT);|
| Active Comparator: Definitive 65<br>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<br> <br> * Other names: Filcon V4;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| questionnaire addressing subjective comfort and wear time | 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 | 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. | 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. | 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. | subjects will be followed-up for one month |