Myopia, Dry Eye
Conditions
Brief summary
The purpose of this study is to evaluate two different types of contact lenses and their effect on dry eyes when compared to wearing glasses in a controlled, low humidity chamber.
Interventions
Commercially marketed, silicone hydrogel, single-vision, soft contact lenses FDA-approved for daily and extended (overnight) wear for up to 30 nights of continuous wear.
Commercially marketed, silicone hydrogel, single-vision, soft contact lenses FDA-approved for daily and extended (overnight) wear for up to 30 nights of continuous wear.
OTHERGlasses
Glasses per habitual prescription
Sponsors
CIBA VISION
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Age 18 to 70. * History of end-of-day or low-humidity dryness with contact lenses. * Healthy eyes. * Best-corrected visual acuity of 20/50 or better for each eye. * Usable pair of eye glasses. * Willing and able to attend required study visits. * Sign informed consent. * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Ocular or systemic allergies or diseases which might interfere with contact lens wear. * Clinically significant ocular findings which would contraindicate contact lens wear. * Unable to abstain from artificial tears or other ophthalmic drops for at least 7 days. * Participation in another clinical study currently or within 30 days of study entry. * Spectacle astigmatism of \>1.00 diopter. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tear Osmolarity | 90 minutes | The participant spent 90 minutes in the LHE (low humidity environment) chamber, after which tears were sampled from the lower tear meniscus (thin strip of tear fluid at the lower lid margin) and tear osmolarity was measured using a TearLab osmometer, a device that measures the osmolarity of human tears to aid in the diagnosis of dry eye disease. Tear osmolarity is the measure of solid particles (salt) in a solution (tears), and a higher number can be indicative of dry eye disease, while a lower number is generally indicative of the normal tear osmolarity. |
| Ocular Comfort | 90 minutes | Ocular comfort was assessed by the participant after 90 minutes in the LHE and quantified as a linear measure (cm) on a modified Visual Analog Scale (VAS) of 0-20 cm, with a higher number indicating greater perceived comfort. |
Countries
Canada
Participant flow
Recruitment details
Twenty-nine participants were randomized into one of three treatment sequences. The study took place at one site, which was located in Canada.
Pre-assignment details
Participants were instructed to use glasses as a washout from their habitual contact lens brand for at least seven days prior to initiating the first of three LHE (Low-Humidity Environment) chamber visits. This reporting group consists of all enrolled participants.
Participants by arm
| Arm | Count |
|---|---|
| Overall This reporting group includes all enrolled participants. | 29 |
| Total | 29 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Period 1, 90 Minutes of Wear | Other | 1 | 0 | 0 |
| Period 2, 90 Minutes of Wear | Other | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Overall |
|---|---|
| Age Continuous | 44.3 years STANDARD_DEVIATION 12.7 |
| Sex: Female, Male Female | 21 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 28 | 0 / 27 | 0 / 27 |
| serious Total, serious adverse events | 0 / 28 | 0 / 27 | 0 / 27 |
Outcome results
Primary
Ocular Comfort
Ocular comfort was assessed by the participant after 90 minutes in the LHE and quantified as a linear measure (cm) on a modified Visual Analog Scale (VAS) of 0-20 cm, with a higher number indicating greater perceived comfort.
Time frame: 90 minutes
Population: As treated.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Lotrafilcon A Contact Lenses | Ocular Comfort | 9.4 cm | Standard Deviation 3.98 |
| Comfilcon A Contact Lenses | Ocular Comfort | 8.2 cm | Standard Deviation 3.3 |
| Glasses | Ocular Comfort | 9.7 cm | Standard Deviation 3.53 |
Primary
Tear Osmolarity
The participant spent 90 minutes in the LHE (low humidity environment) chamber, after which tears were sampled from the lower tear meniscus (thin strip of tear fluid at the lower lid margin) and tear osmolarity was measured using a TearLab osmometer, a device that measures the osmolarity of human tears to aid in the diagnosis of dry eye disease. Tear osmolarity is the measure of solid particles (salt) in a solution (tears), and a higher number can be indicative of dry eye disease, while a lower number is generally indicative of the normal tear osmolarity.
Time frame: 90 minutes
Population: As treated.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lotrafilcon A Contact Lenses | Tear Osmolarity | 310 mOsms/L | Standard Deviation 11 |
| Comfilcon A Contact Lenses | Tear Osmolarity | 313 mOsms/L | Standard Deviation 9 |
| Glasses | Tear Osmolarity | 306 mOsms/L | Standard Deviation 11 |