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OpenTrials
Completed

NCT Number: NCT02553681

Clinical Evaluation of HPT Treated Rigid Contact Lenses Made From Roflufocon D

This will be an up to six months, subject-masked, contralateral, parallel-group, randomised, daily wear study. All subjects will wear the Test lens in one eye and the Control lens in the other eye. Data from the first four weeks of Test and Control lens exposure will be used for the FDA 510 (k) submission.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Siehste

Kassel, Germany

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 the informed consent form
  • Aged ≥18 years old
  • Experienced wearer of rigid gas permeable contact lenses
  • Subject's habitual contact lenses must be made of Contamac's Optimum Extra (roflufocon D) material
  • 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)
  • Corneal astigmatism ≤2.00 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
  • Current wearers of multifocal contact lenses
  • Current wearers of toric contact lenses (front surface design)
  • Current wearers of astigmatic contact lenses (posterior surface design)
  • Has a reported "Strong" comfort or vision preference between each eye with their habitual RGP lenses
  • Unacceptable fit of habitual lenses
  • Pregnant women and nursing mothers
  • Best-corrected visual acuity worse than 6/9 (LogMAR: +0.20; Snellen decimal: 0.63)

Treatment and study plan

roflufocon D contact lenses

Device

HPT treated rigid contact lenses

RGP contact lenses made from roflufocon D

Device

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. conjunctival redness - ocular biomicroscopy

    Time frame: subjects will be followed-up for one month

    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. corneal staining - ocular biomicroscopy

    Time frame: subjects will be followed-up for one month

    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

Official study title

Clinical Evaluation of Hydra-PEG (Polyethylene Glycol) Treatment (HPT) Treated Rigid Contact Lenses Made From Roflufocon D

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Sep 17, 2015
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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