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.

Study Overview

• Status: Completed
• Conditions: Corneal Staining
• Intervention / Treatment: Other: Multipurpose Solution #1; Other: Multipurpose Solution #2; Other: Mutlipurpose Solution #3; Other: Multipurpose Solution #4

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43213
      • Erdey/Searcy Eye Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Multipurpose Solution #1; B&L Renu Fresh Multipurpose Solution	Other: Multipurpose Solution #1; B&L Renu Fresh Multipurpose Solution; Other: Multipurpose Solution #2; Optifree Replenish Multipurpose Solution; Other: Mutlipurpose Solution #3; Ciba ClearCare Multipurpose Solution; Other: Multipurpose Solution #4; Saline Solution
Experimental: Multipurpose Solution #2; OptiFree Replenish Multipurpose Solution	Other: Multipurpose Solution #1; B&L Renu Fresh Multipurpose Solution; Other: Multipurpose Solution #2; Optifree Replenish Multipurpose Solution; Other: Mutlipurpose Solution #3; Ciba ClearCare Multipurpose Solution; Other: Multipurpose Solution #4; Saline Solution
Experimental: Multipurpose Solution #3; Ciba ClearCare Multipurpose Solution	Other: Multipurpose Solution #1; B&L Renu Fresh Multipurpose Solution; Other: Multipurpose Solution #2; Optifree Replenish Multipurpose Solution; Other: Mutlipurpose Solution #3; Ciba ClearCare Multipurpose Solution; Other: Multipurpose Solution #4; Saline Solution
Active Comparator: Multipurpose Solution #4; Saline Solution	Other: Multipurpose Solution #1; B&L Renu Fresh Multipurpose Solution; Other: Multipurpose Solution #2; Optifree Replenish Multipurpose Solution; Other: Mutlipurpose Solution #3; Ciba ClearCare Multipurpose Solution; Other: Multipurpose Solution #4; Saline Solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Corneal Staining Severity	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.	Baseline, 2 Hour Period, 4 Hour Period
Corneal Staining Area	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.	Baseline, 2 Hour Period, 4 Hour Period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective Comfort	Subjective comfort ratings 0-100 (0=causes pain, 100=excellent comfort)	Visit 1: Baseline; Visit 2: 2 hours, Visit 3: 4 hours
Subjective Dryness	Subjective dryness ratings 0-100 (0=extremely dry, 100=extremely moist)	Visit 1: Baseline; Visit 2: 2 hours, Visit 3: 4 hours

Collaborators and Investigators

• Sponsor: CooperVision, Inc.
• Investigators: Principal Investigator: Gary Andrasko, OD, MS, Erdey/Searcy Eye Group

Publications and helpful links

Helpful Links

• Click here for more information about similar studies

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Actual): September 1, 2010
• Study Completion (Actual): September 1, 2010

Study Registration Dates

• First Submitted: October 7, 2010
• First Submitted That Met QC Criteria: April 13, 2011
• First Posted (Estimate): April 14, 2011

Study Record Updates

• Last Update Posted (Actual): July 28, 2020
• Last Update Submitted That Met QC Criteria: July 17, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: corneal staining
• Additional Relevant MeSH Terms: Pharmaceutical Solutions
• Other Study ID Numbers: CV-09-64, Sterling IRB 3576