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OpenTrials
Completed

NCT Number: NCT00636363

Safety and Efficacy of a Bausch & Lomb Multipurpose Solution When Compared to Ciba Vision Aquify Multipurpose Solution

To the safety and efficacy of a Bausch & Lomb Multipurpose Solution when compared to Ciba vision Aquify Multipurpose solution

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Key information

Conditions

Contact Lens Solutions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Place Eye Care

Le Roy, New York, 14482, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • subject is a habitual wearer of a silicone hydrogel or group IV contact lens
  • VA correctable to 0.3 LogMar or better (driving vision)
  • Clear central cornea
  • Subject uses a lens care system on a regular basis

Exclusion criteria

  • Systemic disease affecting ocular health
  • Using systemic or topical medications
  • wear monovision, multifocal or toric contact lenses
  • Any grade 2 or greater slit lamp findings

Treatment and study plan

Bausch & Lomb Multipurpose Solution - Rub Care

Device

Daily care for contact lenses - rub care regimen

Bausch & Lomb Multipurpose Solution - No Rub Care

Device

Daily care for contact lenses - no rub care regimen

Ciba Vision Aquify Multipurpose Solution

Device

daily care for contact lenses

Primary outcomes

  1. Slit-lamp Findings > Grade 2

    Time frame: Over 4 visits for 3 month period

    eyes with any slit lamp findings greater than Grade 2 at any visit. Slit lamp findings for each eye will be graded for severity on a scale from 0 (No Finding) to 4 (Severe Finding). Epithelial edema, epithelial microcysts, corneal staining, limbal injection, bulbar injection, superior tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates will be assessed.

  2. Subjective Responses to Comfort Related Symptoms/Complaints

    Time frame: Over 4 visits for the 3 month period

    Subject symptoms/complaints will be assessed on a scale from 0 to 100, with 0 denoting unfavorable symptoms/complaints.

  3. Contact Lens Deposits

    Time frame: At each visit for 3 months

    Lens deposits assessed at each follow-up visit. Degree of deposits assessed as none, light, medium, or heavy.

Sponsors and collaborators

Lead sponsor

Bausch & Lomb Incorporated

Industry

Registry information

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Mar 14, 2008
Registry last updated
Mar 24, 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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