Clinical trial NCT01335750: A Clinical Comparison of Marketed Lens Care Solutions With Avaira Lens Brand
Official title: A Clinical Comparison of Marketed Lens Care Solutions With Avaira Lens Brand
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Corneal Staining
Keywords: corneal staining
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2011-04-14
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Corneal Staining Severity
timeFrame: Baseline, 2 Hour Period, 4 Hour Period
measure: Corneal Staining Area
timeFrame: Baseline, 2 Hour Period, 4 Hour Period
Secondary outcomes:
measure: Subjective Comfort
timeFrame: Visit 1: Baseline; Visit 2: 2 hours, Visit 3: 4 hours
measure: Subjective Dryness
timeFrame: Visit 1: Baseline; Visit 2: 2 hours, Visit 3: 4 hours
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Erdey/Searcy Eye Group
state: Ohio
Study officials:
affiliation: Erdey/Searcy Eye Group
name: Gary Andrasko, OD, MS
role: PRINCIPAL_INVESTIGATOR
References: