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OpenTrials
Completed

NCT Number: NCT00349843

Investigation of Multi-Purpose Solution-Based Corneal Staining and Ocular Comfort

The primary objective of this study is to compare subjective ocular symptoms and corneal staining over time in a group of individuals who wear soft contact lenses on a daily wear basis, whilst they sequentially use two different contact lens care regimens.

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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Centre for Contact Lens Research, University of Waterloo

Waterloo, Ontario, N2L 3G1, Canada

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Agrees to wear the study lenses on a daily wear basis without the use of ocular lubricants.
  • Has an up to date pair of glasses and is willing to wear these glasses at different times during the study.
  • Is correctable to a visual acuity of 6/6 or better with their habitual correction.
  • Is willing and able to follow product usage instructions and maintain the visit schedule.
  • Is at least 18 years of age and has full legal capacity to volunteer.
  • Can be successfully fitted with study lens type.
  • Has read, understood and signed an Information Consent Letter.
  • Has a distance contact lens prescription is between -0.50 D and -9.00 D
  • Has astigmatism of ≤ 1.00 D Cyl
  • Has normal binocular vision, i.e. no strabismus, no amblyopia, and anisometropia of ≤ 1.00D
  • Has no systemic disease affecting ocular health.
  • Is not using any systemic or topical medications that will affect ocular health, accommodative function, or the ocular physiological response to the contact lenses.
  • Has clear corneas and no active ocular disease.
  • Has no known ocular or systemic allergies, which could interfere with contact lens wear.
  • Has no lid or conjunctival abnormalities, neovascularization, limbal injection, bulbar injection or corneal staining, which in the investigator's opinion is clinically significant.
  • Has not worn rigid contact lenses in the last 30 days or has corneal distortion resulting from rigid lens wear.
  • Has not worn extended wear contact lenses in the last 30 days.
  • Has had an oculo-visual examination in the last two years

Exclusion criteria

  • Has any active ocular disease.
  • Has any lid or conjunctival abnormalities that may, in the opinion of the investigator, interfere with the wear of contact lenses.
  • Has edema, staining, clinically significant corneal opacity, dystrophy, vascularization or iritis as viewed by slit lamp. (Trace or grade 1 equivalent limbal and bulbar injection or corneal staining is permissible at the discretion of the investigator.)
  • Is using ocular lubricants or contact lens rewetting drops on a regular basis (at least once per day)
  • Is using topical ocular prescription or any topical over-the-counter medication.
  • Is actively involved in any other research/clinical study.
  • Has worn rigid lenses or soft lenses on an extended wear basis within the last 30 days.
  • Has had corneal refractive surgery.
  • Has known sensitivity to any of the study solutions.

Treatment and study plan

Soft contact lens

Device

Marketed soft lens multipurpose disinfection regimen

Drug

Primary outcomes

  1. The primary objective of this study is to compare corneal staining over time in

  2. a group of individuals who wear soft contact lenses on a daily wear basis,

  3. whilst they sequentially use two different contact lens care regimens.

Secondary outcomes

  1. The secondary objective of this study is to compare subjective ocular symptoms

  2. over time in a group of individuals who wear soft contact lenses on a daily wear

  3. basis, whilst they sequentially use two different contact lens care regimens.

Sponsors and collaborators

Lead sponsor

University of Waterloo

Other

Collaborators

  • Alcon Research

Registry information

Official study title

Investigation of Multi-Purpose Solution-Based Corneal Staining and Ocular Comfort With Daily Wear FDA Group IV Hydrogel Lenses

Important dates

Study start
2005
First posted
Jul 10, 2006
Registry last updated
Dec 16, 2015

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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