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OpenTrials
Completed

NCT Number: NCT02312323

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

Comparison of different contact lens materials.

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Key information

Conditions

Ametropia Eye Diseases Refractive Errors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Siehste, Kassel, Germany

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Definitive 65 HPT contact lenses

Device

Other names: Filcon V4 (HPT)

Definitive 65 contact lenses

Device

Other names: Filcon V4

Primary outcomes

  1. questionnaire addressing subjective comfort and wear time

    Time frame: 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'.

  2. limbal redness - ocular biomicroscopy

    Time frame: 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.

  3. conjunctival redness - ocular biomicroscopy

    Time frame: 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.

  4. corneal staining - ocular biomicroscopy

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Contamac Ltd

Industry

Collaborators

  • Hartwig Research Center

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Dec 9, 2014
Registry last updated
Aug 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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