Corneal Staining
Conditions
Keywords
corneal staining
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.
Interventions
OTHERMultipurpose Solution #1
B&L Renu Fresh Multipurpose Solution
OTHERMultipurpose Solution #2
Optifree Replenish Multipurpose Solution
OTHERMutlipurpose Solution #3
Ciba ClearCare Multipurpose Solution
OTHERMultipurpose Solution #4
Saline Solution
Sponsors
CooperVision, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Corneal Staining Severity | 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. |
| Corneal Staining Area | 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
| Measure | Time frame | Description |
|---|---|---|
| Subjective Comfort | Visit 1: Baseline; Visit 2: 2 hours, Visit 3: 4 hours | Subjective comfort ratings 0-100 (0=causes pain, 100=excellent comfort) |
| Subjective Dryness | Visit 1: Baseline; Visit 2: 2 hours, Visit 3: 4 hours | Subjective dryness ratings 0-100 (0=extremely dry, 100=extremely moist) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Multipurpose Solution To obtain results of a clinical comparison of several multipurpose contact lens solutions among adapted hydrogel lens users wearing Avaira contact lenses | 32 |
| Total | 32 |
Baseline characteristics
| Characteristic | Multipurpose Solution |
|---|---|
| Age, Continuous | 32 Years |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 32 |
| serious Total, serious adverse events | 0 / 32 |
Outcome results
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.
Time frame: Baseline, 2 Hour Period, 4 Hour Period
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Multipurpose Solution #1 | Corneal Staining Area | 2 Hour Period | 1.2 units on a scale | Standard Deviation 2.1 |
| Multipurpose Solution #1 | Corneal Staining Area | 3 Hour Period | 0.9 units on a scale | Standard Deviation 1.6 |
| Multipurpose Solution #1 | Corneal Staining Area | Baseline | 0.1 units on a scale | Standard Deviation 0 |
| Multipurpose Solution #2 | Corneal Staining Area | Baseline | 0.1 units on a scale | Standard Deviation 0 |
| Multipurpose Solution #2 | Corneal Staining Area | 3 Hour Period | 10.3 units on a scale | Standard Deviation 11.4 |
| Multipurpose Solution #2 | Corneal Staining Area | 2 Hour Period | 17.1 units on a scale | Standard Deviation 13.2 |
| Multipurpose Solution #3 | Corneal Staining Area | 2 Hour Period | 0.6 units on a scale | Standard Deviation 1.3 |
| Multipurpose Solution #3 | Corneal Staining Area | Baseline | 0.2 units on a scale | Standard Deviation 0 |
| Multipurpose Solution #3 | Corneal Staining Area | 3 Hour Period | 0.8 units on a scale | Standard Deviation 1.4 |
| Multipurpose Solution #4 | Corneal Staining Area | Baseline | 0.1 units on a scale | Standard Deviation 0 |
| Multipurpose Solution #4 | Corneal Staining Area | 3 Hour Period | 0.8 units on a scale | Standard Deviation 1.7 |
| Multipurpose Solution #4 | Corneal Staining Area | 2 Hour Period | 0.7 units on a scale | Standard Deviation 1.3 |
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.
Time frame: Baseline, 2 Hour Period, 4 Hour Period
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Multipurpose Solution #1 | Corneal Staining Severity | Baseline | 0.01 units on a scale |
| Multipurpose Solution #1 | Corneal Staining Severity | 3 Hour Period | 0.06 units on a scale |
| Multipurpose Solution #1 | Corneal Staining Severity | 2 Hour Period | 0.10 units on a scale |
| Multipurpose Solution #2 | Corneal Staining Severity | Baseline | 0.01 units on a scale |
| Multipurpose Solution #2 | Corneal Staining Severity | 3 Hour Period | 0.59 units on a scale |
| Multipurpose Solution #2 | Corneal Staining Severity | 2 Hour Period | 0.76 units on a scale |
| Multipurpose Solution #3 | Corneal Staining Severity | 2 Hour Period | 0.05 units on a scale |
| Multipurpose Solution #3 | Corneal Staining Severity | Baseline | 0.02 units on a scale |
| Multipurpose Solution #3 | Corneal Staining Severity | 3 Hour Period | 0.06 units on a scale |
| Multipurpose Solution #4 | Corneal Staining Severity | Baseline | 0.01 units on a scale |
| Multipurpose Solution #4 | Corneal Staining Severity | 3 Hour Period | 0.06 units on a scale |
| Multipurpose Solution #4 | Corneal Staining Severity | 2 Hour Period | 0.06 units on a scale |
Secondary
Subjective Comfort
Subjective comfort ratings 0-100 (0=causes pain, 100=excellent comfort)
Time frame: Visit 1: Baseline; Visit 2: 2 hours, Visit 3: 4 hours
Population: Subjective comfort ratings 0-100 (0=causes pain, 100=excellent comfort)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Multipurpose Solution #1 | Subjective Comfort | Baseline | 82.9 units on a scale | Standard Deviation 15 |
| Multipurpose Solution #1 | Subjective Comfort | 4 Hour Period | 80.5 units on a scale | Standard Deviation 14.7 |
| Multipurpose Solution #1 | Subjective Comfort | 2 Hour Period | 83.2 units on a scale | Standard Deviation 13.9 |
| Multipurpose Solution #2 | Subjective Comfort | Baseline | 80.3 units on a scale | Standard Deviation 14.6 |
| Multipurpose Solution #2 | Subjective Comfort | 4 Hour Period | 78.0 units on a scale | Standard Deviation 18.7 |
| Multipurpose Solution #2 | Subjective Comfort | 2 Hour Period | 81.6 units on a scale | Standard Deviation 15.8 |
| Multipurpose Solution #3 | Subjective Comfort | 2 Hour Period | 85.6 units on a scale | Standard Deviation 13.9 |
| Multipurpose Solution #3 | Subjective Comfort | Baseline | 84.8 units on a scale | Standard Deviation 13.4 |
| Multipurpose Solution #3 | Subjective Comfort | 4 Hour Period | 83.4 units on a scale | Standard Deviation 16.3 |
| Multipurpose Solution #4 | Subjective Comfort | Baseline | 84.7 units on a scale | Standard Deviation 14 |
| Multipurpose Solution #4 | Subjective Comfort | 4 Hour Period | 85.3 units on a scale | Standard Deviation 14.5 |
| Multipurpose Solution #4 | Subjective Comfort | 2 Hour Period | 83.7 units on a scale | Standard Deviation 14.5 |
Secondary
Subjective Dryness
Subjective dryness ratings 0-100 (0=extremely dry, 100=extremely moist)
Time frame: Visit 1: Baseline; Visit 2: 2 hours, Visit 3: 4 hours
Population: Subjective dryness ratings 0-100 (0=extremely dry, 100=extremely moist)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Multipurpose Solution #1 | Subjective Dryness | 4 Hour Period | 81.4 units on a scale | Standard Deviation 15.3 |
| Multipurpose Solution #1 | Subjective Dryness | Baseline | 84.9 units on a scale | Standard Deviation 14 |
| Multipurpose Solution #1 | Subjective Dryness | 2 Hour Period | 82.8 units on a scale | Standard Deviation 13.2 |
| Multipurpose Solution #2 | Subjective Dryness | 2 Hour Period | 76.9 units on a scale | Standard Deviation 19.4 |
| Multipurpose Solution #2 | Subjective Dryness | Baseline | 81.1 units on a scale | Standard Deviation 15.3 |
| Multipurpose Solution #2 | Subjective Dryness | 4 Hour Period | 76.2 units on a scale | Standard Deviation 20.1 |
| Multipurpose Solution #3 | Subjective Dryness | 4 Hour Period | 81.9 units on a scale | Standard Deviation 16.8 |
| Multipurpose Solution #3 | Subjective Dryness | Baseline | 85.0 units on a scale | Standard Deviation 14.4 |
| Multipurpose Solution #3 | Subjective Dryness | 2 Hour Period | 83.0 units on a scale | Standard Deviation 15.3 |
| Multipurpose Solution #4 | Subjective Dryness | 2 Hour Period | 81.7 units on a scale | Standard Deviation 16.6 |
| Multipurpose Solution #4 | Subjective Dryness | Baseline | 85.1 units on a scale | Standard Deviation 13.1 |
| Multipurpose Solution #4 | Subjective Dryness | 4 Hour Period | 83.1 units on a scale | Standard Deviation 17.4 |