Astigmatism, Hyperopia, Myopia
Conditions
Brief summary
A new multi-purpose solution (MPS)was clinically evaluated against Opti-Free RepleniSH MPS at specific time points over the course of four days. The study was conducted with PureVision lenses.
Interventions
DEVICERevitaLens OcuTec MPS (Investigational MPS) and Opti-Free RepleniSH MPS (control)
multi-purpose lens care solution
Sponsors
Abbott Medical Optics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
* were at least 18 years old; * were experienced contact lens wearers; * were correctable to at least 20/40 or better in both eyes with contact lenses; * were in good general health, with healthy eyes (other than requiring vision correction); * had not worn lenses for at least 12 hours before each baseline visit; * had a corneal staining score no greater than Grade 1 in either eye at time of enrollment; * had previously used an MPS or hydrogen peroxide solution successfully.
Exclusion criteria
* had a confirmed diagnosis of Sjögren's syndrome or other condition that results in a chronic and/or pathologic dry eye condition; * required concurrent ocular medication or have used ocular medication within 24 hours of entering the study; * had a known sensitivity or intolerance to any MPS, study products or ingredient(s); * were currently participating in any other clinical study; * had a condition or are in a situation that, in the investigator's opinion, may put them at significant risk, confound the study results, or interfere significantly with their participation in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Eyes With No Change in Corneal Staining | Change from baseline after 1, 2, 4 and 6+ hours of wear | Subjects examined after corneal staining (a method used to assess the condition of the cornea) using a slit lamp to determine change from baseline and rated based on the following scale: 0=no change from baseline, 1=trace, 2=mild, 3=moderate, 4=severe. |
Countries
United States
Participant flow
Recruitment details
Recruitment of employees occurred 7/8/2010 - 10/1/2010 thru employee bulletin for study taking place at in-house optometric clinic.
Pre-assignment details
Prior to baseline visit subjects were instructed to undergo a washout period where no contacts were worn for 12 hours. Slit lamp exam was conducted prior to randomized group assignment. Eyes were thoroughly rinsed with unit-dose aline before pre-soaked study lenses were inserted.
Participants by arm
| Arm | Count |
|---|---|
| RevitaLens and OptiFree 30 subjects, one eye received RevitaLens MPS (investigational), one eye received Opti-Free RepleniSH MPS(control). | 30 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Inclusion/exclusion criteria | 1 |
Baseline characteristics
| Characteristic | RevitaLens and OptiFree |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants |
| Region of Enrollment United States | 30 participants |
| Sex/Gender, Customized Unknown | 30 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
Primary
Number of Eyes With No Change in Corneal Staining
Subjects examined after corneal staining (a method used to assess the condition of the cornea) using a slit lamp to determine change from baseline and rated based on the following scale: 0=no change from baseline, 1=trace, 2=mild, 3=moderate, 4=severe.
Time frame: Change from baseline after 1, 2, 4 and 6+ hours of wear
Population: per protocol
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RevitaLens | Number of Eyes With No Change in Corneal Staining | 4 Hours - No Change | 21 eyes |
| RevitaLens | Number of Eyes With No Change in Corneal Staining | 2 Hours - No Change | 19 eyes |
| RevitaLens | Number of Eyes With No Change in Corneal Staining | End of Day (>6 hrs) - No Change | 19 eyes |
| RevitaLens | Number of Eyes With No Change in Corneal Staining | 1 Hour - No Change | 16 eyes |
| OptiFree | Number of Eyes With No Change in Corneal Staining | 2 Hours - No Change | 14 eyes |
| OptiFree | Number of Eyes With No Change in Corneal Staining | 1 Hour - No Change | 17 eyes |
| OptiFree | Number of Eyes With No Change in Corneal Staining | End of Day (>6 hrs) - No Change | 20 eyes |
| OptiFree | Number of Eyes With No Change in Corneal Staining | 4 Hours - No Change | 21 eyes |