Dry Eye
Conditions
Brief summary
to evaluate tears between habitual contact lens wearers and non contact lens wearers
Detailed description
The objective of this study is to evaluate tears between habitual contact lens wearers and non contact lens wearers using a Schirmer Strip for tear collection.
Interventions
DEVICEContact Lens Wear
Senofilcon A lenses will be rubbed and rinsed with Bausch + Lomb Sensitive Eyes Saline. The lenses will then be placed into Biotrue multi-purpose solution and soaked for at least 10 hours but no more than 24 hours prior to lens insertion into one eye.
OTHERNon-Contact Lens Wear
No intervention
Sponsors
Bausch & Lomb Incorporated
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Have no allergic conjunctivitis. * Not be using any topical ocular medications.
Exclusion criteria
* Considered by the Investigator to not be a suitable candidate for participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hyaluronan Levels | 7 days following lens insertion | Tear samples collected using a Schirmer tear strip and analyzed for hyaluronan (HA) levels, a lubricant found throughout the body, including tears. Levels will be compared between the lens wearers and non-lens wearers. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Contact Lens Wear Senofilcon A Lenses, using Sensitive Eyes Saline Solution and/or Biotrue Multipurpose Solution
Contact Lens Wear: Senofilcon A lenses will be rubbed and rinsed with Bausch + Lomb Sensitive Eyes Saline. The lenses will then be placed into Biotrue multi-purpose solution and soaked for at least 10 hours but no more than 24 hours prior to lens insertion into one eye.
Contact Lens Wear: Senofilcon A lenses will be rubbed and rinsed each side with Bausch + Lomb Sensitive Eyes Saline just prior to lens insertion into fellow eye. | 12 |
| Non-Contact Lens Wear Non-Contact Lens Wear: No intervention | 13 |
| Total | 25 |
Baseline characteristics
| Characteristic | Contact Lens Wear | Non-Contact Lens Wear | Total |
|---|---|---|---|
| Age, Continuous | 41 years | 41 years | 41 years |
| Sex: Female, Male Female | 6 Participants | 6 Participants | 12 Participants |
| Sex: Female, Male Male | 6 Participants | 7 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 12 | 0 / 13 |
| serious Total, serious adverse events | 0 / 12 | 0 / 13 |
Outcome results
Primary
Hyaluronan Levels
Tear samples collected using a Schirmer tear strip and analyzed for hyaluronan (HA) levels, a lubricant found throughout the body, including tears. Levels will be compared between the lens wearers and non-lens wearers.
Time frame: 7 days following lens insertion
Population: DUE TO THE CANCELLATION OF THIS PROJECT, NO STATISTICAL OR CLINICALLY MEANINGFUL CONCLUSIONS RELATED TO THE STUDY ENDPOINTS WERE MADE.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Contact Lens Wear | Hyaluronan Levels | 4.52 ng/mL | Standard Error 0.232 |
| Non-Contact Lens Wear | Hyaluronan Levels | 4.07 ng/mL | Standard Error 0.183 |