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Completed

NCT Number: NCT01335750

A Clinical Comparison of Marketed Lens Care Solutions With Avaira Lens Brand

This study is a clinical comparison of the biocompatibility of several multipurpose solutions, Renu Fresh, Optifree Replenish, and ClearCare, and saline as a control solution among adapted hydrogel contact lens wearers wearing Avaira (enfilcon A) contact lenses at one research site.

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Key information

Conditions

Corneal Staining

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Erdey/Searcy Eye Group

Columbus, Ohio, 43213, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Informed Consent and HIPAA document read, signed, and dated.
  • Visual acuity correctable to 20/30 (Snellen) or better in each eye at distance with hydrogel or silicone hydrogel contact lenses.
  • Successfully wearing hydrogel or silicone hydrogel contact lenses on a daily wear basis for at least two weeks prior to the study.

Exclusion criteria

  • History of hypersensitivity
  • Evidence or history of epithelial herpes simplex keratitis (dendritic keratitis; vaccinia, active or recent varicella, viral disease of the cornea and/or conjunctiva and/or eyelids; bacterial infection of the eye; and/or fungal disease of the eye
  • One functional eye or a monofit eye
  • Ocular conditions such as active acute blepharitis, conjunctival infections, and iritis
  • Type 2 (macropunctate) or greater corneal staining in any region in either eye as observed by slit-lamp at Visit 1 of each study period
  • Sum of the type of corneal staining greater than or equal to 4 across entire cornea in either eye as observed by slit-lamp at Visit 1 of each study period
  • Conjunctival staining covering greater than or equal to 20% in 2 or more corneal regions in either eye as observed by slit-lamp at Visit 1 of each study period
  • Conjunctival injection greater than Grade 2 (moderate-diffuse redness) in either eye as observed by slit-lamp at Visit 1 of each study period
  • Abnormal lenticular opacity in the visual axis of the lens in either eye
  • Use of concomitant topical Rx or over-the-counter (OTC) ocular medications
  • History of seasonal allergies with significant ocular side effects which may have an adverse impact on contact lens wear
  • Pregnant or lactating females

Treatment and study plan

Multipurpose Solution #1

Other

B&L Renu Fresh Multipurpose Solution

Multipurpose Solution #2

Other

Optifree Replenish Multipurpose Solution

Mutlipurpose Solution #3

Other

Ciba ClearCare Multipurpose Solution

Multipurpose Solution #4

Other

Saline Solution

Primary outcomes

  1. Corneal Staining Severity

    Time frame: Baseline, 2 Hour Period, 4 Hour Period

    Severity of staining was recorded for each region using a scale of 0-none to 4-patch >/=1mm. Analysis of staining was performed by averaging the scores from the five regions for each eye, then identifying the subject's worse eye at each visit. Mean total severity was calcuated from all identified eyes for each visit.

  2. Corneal Staining Area

    Time frame: Baseline, 2 Hour Period, 4 Hour Period

    Analysis of staining area was performed by averaging the values from the five regions for each eye and then identifying the subject's worse eye at each visit. Mean total area was calculated from all identified eyes for each visit.

Secondary outcomes

  1. Subjective Comfort

    Time frame: Visit 1: Baseline; Visit 2: 2 hours, Visit 3: 4 hours

    Subjective comfort ratings 0-100 (0=causes pain, 100=excellent comfort)

  2. Subjective Dryness

    Time frame: Visit 1: Baseline; Visit 2: 2 hours, Visit 3: 4 hours

    Subjective dryness ratings 0-100 (0=extremely dry, 100=extremely moist)

Sponsors and collaborators

Lead sponsor

CooperVision, Inc.

Industry

Registry information

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Apr 14, 2011
Registry last updated
Jul 28, 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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