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

Corneal Staining Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01335750
• Other study ID #: CV-09-64, Sterling IRB 3576
• Status: Completed
• Phase: N/A
• Start date: August 2010
• Est. completion date: September 2010

Study information

• Verified date: July 2020
• Source: Coopervision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Corneal Staining

Intervention

Other:
• Multipurpose Solution #1
B&L Renu Fresh Multipurpose Solution
• Multipurpose Solution #2
Optifree Replenish Multipurpose Solution
• Mutlipurpose Solution #3
Ciba ClearCare Multipurpose Solution
• Multipurpose Solution #4
Saline Solution

Locations

Country	Name	City	State
United States	Erdey/Searcy Eye Group	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Coopervision, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Subjective Comfort	Subjective comfort ratings 0-100 (0=causes pain, 100=excellent comfort)	Visit 1: Baseline; Visit 2: 2 hours, Visit 3: 4 hours
Secondary	Subjective Dryness	Subjective dryness ratings 0-100 (0=extremely dry, 100=extremely moist)	Visit 1: Baseline; Visit 2: 2 hours, Visit 3: 4 hours

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