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OpenTrials
Completed

NCT Number: NCT00658996

Product Performance of a Toric Contact Lens

Product performance of a Bausch & Lomb Toric Contact Lens compared to Ciba Vision Focus Daily Toric Contact Lens

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Key information

Conditions

Myopia Astigmatism Eye Diseases Refractive Errors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Laser Focus Sdn Bhd, Vision Correction Centre

Johor Bahru, 80400, Malaysia

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subject is an adapted soft contact lens wearer with astigmatism of 0.50 Diopter or greater
  • Visual acuity (VA) correctable to 0.3 logMar or better (driving vision)
  • Clear central cornea

Exclusion criteria

  • Systemic disease affecting ocular health
  • Using systemic or topical medications
  • Wears monovision or multifocal contact lenses
  • Any grade 2 or greater slit lamp findings
  • Adapted wearer of Ciba Focus Dailies Toric lens upon study entry

Treatment and study plan

SofLens DD Toric

Device

daily disposable wear contact lens for 2 weeks

Ciba Vision Focus Dailies Toric Contact Lens

Device

daily disposable wear contact lens for 2 weeks

Primary outcomes

  1. Symptoms and Complaints

    Time frame: Over-all follow-up visits for 2 week period

    1-100 Scale for each eye. Zero represented the least favorable rating and 100 represented the most favorable.

  2. Contact Lens High Contrast Visual Acuity

    Time frame: Over-all follow-up visits, 2 weeks

    VA measures at each scheduled visit were averaged to obtain an overall measure for each eye. A non-inferiority upper bound of 0.06 (3 letters) were used to assess the difference (Test - Control) in overall logMAR VA.

Secondary outcomes

  1. Slit Lamp Findings

    Time frame: Over-all follow-up visits, 2 weeks

    Graded 0-4 where 0=none and 4=severe on measure of epithelial edema, epithelial microcysts, corneal staining, limbal injection, bulbar injection, superior tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates

Sponsors and collaborators

Lead sponsor

Bausch & Lomb Incorporated

Industry

Registry information

Official study title

A Study to Evaluate the Product Performance of a Prism-Ballasted Toric Contact Lens When Worn by Currently Adapted Soft Contact Lens Wearers.

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Apr 16, 2008
Registry last updated
Dec 12, 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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