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

Ametropia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02312323
• Other study ID #: CM-001-002
• Status: Completed
• Phase: N/A
• Start date: November 8, 2014
• Est. completion date: May 23, 2015

Study information

• Verified date: August 2020
• Source: Contamac Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Comparison of different contact lens materials.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: May 23, 2015
• Est. primary completion date: May 23, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Ametropia
• Refractive Errors

Intervention

Device:
• Definitive 65 HPT contact lenses

• Definitive 65 contact lenses

Locations

Country	Name	City	State
Germany	Siehste	Kassel
Germany	Kresinky	Würzburg

Sponsors (2)

Lead Sponsor	Collaborator
Contamac Ltd	Hartwig Research Center

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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