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

NCT02312323 | Completed

• 1 other identifier: CM-001-002
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 2

Brief Summary

Comparison of different contact lens materials.

Conditions

Ametropia

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Definitive 65 HPT

EXPERIMENTAL

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

Definitive 65

ACTIVE COMPARATOR

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

Interventions

Definitive 65 HPT contact lenses DEVICE

Also known as: Filcon V4 (HPT)

Definitive 65 HPT

Definitive 65 contact lenses DEVICE

Also known as: Filcon V4

Definitive 65

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Contamac Ltd: lead
• Hartwig Research Center: collaborator

Study Sites (2)

Siehste

Kassel, Germany

Location

Kresinky

Würzburg, Germany

Location

MeSH Terms

Conditions

Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• Andreas Hartwig, PhD, FAAO

  Hartwig Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2014
• First Posted: December 9, 2014
• Study Start: November 8, 2014
• Primary Completion: May 23, 2015
• Study Completion: May 23, 2015
• Last Updated: August 12, 2020

Record last verified: 2020-08

Locations

DE (2)