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

Not Applicable

Completed

• Conditions: Ametropia

• Registration Number: NCT02312323
• Lead Sponsor: Contamac Ltd

Brief Summary

Comparison of different contact lens materials.

Detailed Description

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.

Study Timeline

• Study Start: 2014-11-08
• Study First Submitted: 2014-11-28
• Study First Submitted QC: 2014-12-06
• Study First Posted: 2014-12-09
• Primary Completion: 2015-05-23
• Study Completion: 2015-05-23
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-10
• Last Update Posted: 2020-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
corneal staining - ocular biomicroscopy	subjects will be followed-up for one month	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.
questionnaire addressing subjective comfort and wear time	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'.
limbal redness - ocular biomicroscopy	subjects will be followed-up for one month	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.
conjunctival redness - ocular biomicroscopy	subjects will be followed-up for one month	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.

Trial Locations

Locations (2)

Siehste; 🇩🇪 Kassel, Germany

Kresinky; 🇩🇪 Würzburg, Germany