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OpenTrials
Completed

NCT Number: NCT00371787

Evaluation of the Performance of Non-molded Soft Contact Lenses

To evaluate the performance of the study soft lens for vision, comfort, physiology and lens surface properties.

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Key information

Conditions

Ametropia Eye Diseases Refractive Errors

Age range

17 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Centre for Contact Lens Research, University of Waterloo,

Waterloo, Ontario, N2L 3G1, Canada

About this study

To evaluate the performance of the study soft lens for vision, comfort, physiology and lens surface properties in a group of participants who present with lens related changes.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Male or female, good health, age >17yrs, able to wear contact lenses as primary vision correction, able to see well and achieve good fit with study lens, has understood & signed consent form.

Exclusion criteria

  • Has active ocular disease, uses topical eye medication, wears gas permeable/silicone hydrogel /overnight wear contact lenses, is a participant in another clinical study, is deemed unsuitable for soft contact lens wear.

Treatment and study plan

Soft contact lens

Device

Soft contact lens

Other names: Custom O2Optix

Primary outcomes

  1. Visual Acuity

    Time frame: baseline

    level of vision measured using high contrast acuity chart, higher (more positive)logMAR indicates worse vision.

  2. Visual Acuity

    Time frame: 9 month

    level of vision measured using high contrast acuity chart, higher (more positive)logMAR indicates worse vision.

  3. Neovascularisation

    Time frame: baseline

    length of the blood vessels entering the superior cornea, higher number means longer blood vessel penetration.

  4. Neovascularization

    Time frame: 9 month

    length of the blood vessels entering the superior cornea, higher number means longer blood vessel penetration.

Sponsors and collaborators

Lead sponsor

University of Waterloo

Other

Collaborators

  • CIBA VISION

Registry information

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Sep 4, 2006
Registry last updated
Jan 10, 2011

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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