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OpenTrials
Completed

NCT Number: NCT01309867

A Study to Evaluate the Performance of Two Designs of Soft Toric Lenses

The objective of the study is to evaluate the product performance of the Bausch + Lomb toric investigational contact lenses compared to the currently marketed PureVision toric contact lenses.

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Key information

Conditions

Myopia Eye Diseases Refractive Errors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bausch & Lomb

Rochester, New York, 14609, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Subjects must have clear central corneas and be free of any anterior segment disorders.
  • Subjects must be adapted lens wearers, wear a lens in each eye and each lens must be of the same manufacture and brand.
  • Subjects must be myopic and require lens correction
  • Subjects must be habitual wearers of toric soft contact lenses.

Exclusion criteria

  • Subjects with any systemic disease currently affecting ocular health or which in the Investigator's opinion may have an effect on ocular health during the course of the study.
  • Subjects using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
  • Subjects with an active ocular disease or who are using any ocular medication.
  • Subjects with any grade 2 or greater finding during the slit lamp examination. Subjects with corneal infiltrates, of ANY GRADE, are not eligible.
  • Subjects with any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
  • Subjects who are allergic to any component in the study care products.

Treatment and study plan

Investigational Toric Lens

Device

Bausch & Lomb investigational toric contact lens worn on a daily wear basis for 2 weeks.

PureVision Toric Lens

Device

Currently marked Bausch & Lomb PureVision Toric Lens worn on a daily wear basis for 2 weeks.

Primary outcomes

  1. Percentage of Eyes With Absolute Lens Rotation ≤ 10 Degrees.

    Time frame: 2 weeks

  2. Visual Acuity

    Time frame: 2 weeks

    Visual acuity was assessed by distance high contrast logarithm of the minimum angle of resolution (logMAR).

Secondary outcomes

  1. Symptoms and Complaints

    Time frame: 2 weeks

    Symptoms/complaints were assessed on a scale from 0 to 100, with 0 denoting unfavorable symptoms/complaints. Symptoms/complaints were recorded at each post-dispensing visit based on the subject's experience with the study lens worn prior to the visit. The symptoms/complaints parameters were: Burning/stinging upon insertion; Comfort upon insertion, Overall comfort, and Comfort at the end of the day; Ease of handling/insertion, and Ease of handling/removal; Dryness; Itchiness; Redness; Vision; Lens cleanliness; and Overall impression.

  2. Percentage of Eyes With > Grade 2 Slit Lamp Findings

    Time frame: 2 weeks

    Graded slit lamp findings for each eye, including epithelial edema, epithelial microcysts, corneal staining, limbal and bulbar injections, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates were graded for severity on a scale from 0 (No Finding) to 4 (Severe Finding). The outcome measure is any finding > grade 2, across abnormalities.

Sponsors and collaborators

Lead sponsor

Bausch & Lomb Incorporated

Industry

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Mar 7, 2011
Registry last updated
Oct 8, 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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