Dry eyes, tear film Eye Diseases Other disorders of lacrimal gland
Conditions
Interventions
The etiology of contact lens dry eye has been traditionally reported to be due to excessive evaporation associated with an abnormal lipid layer, however, recent work indicates that the problem is more
Sponsors
CooperVision Inc. (USA)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. At least 18 years old 2. Have read and understood the Participant Information Sheet 3. Have read, signed and dated the Informed Consent 4. Current spherical daily contact lens wearer 5. Spectacle refraction: Distance: Sphere: -6.00D to + 4.00D; Astigmatism: 0.00D to -0.75D 6. Best corrected visual acuity of at least 20/30 in each eye 7. Symptomatic wearers (test group): 7.1. At least three hours difference between daily wearing time and comfortable wearing time 7.2. Classified as symptomatic as per study criteria 8. Asymptomatic wearers (control group): 8.1. At most two hours difference between daily wearing time and comfortable wearing time 8.2. Classified as asymptomatic as per study criteria 9. Have normal eyes with the exception of the need for visual correction 10. Be willing and able to adhere to the instructions set in the clinical protocol and maintain the appointment schedule
Exclusion criteria
Exclusion criteria: 1. Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear 2. Use of systemic or ocular medications for which contact lens wear could be contraindicates as determined by the investigator 3. Monocular participants (only one eye with functional vision) or participants fit with only one lens 4. Any moderate or severe ocular condition observed during the slit-lamp examination at the enrolment visit 5. History of herpetic keratitis, ocular surgery or irregular cornea 6. Known pregnancy or lactation during the study period 7. Enrolment of the investigator or his/her staff, family members of the investigator, family members of the investigator’s staff, or individuals living in the households of these individuals 8. Participation in any clinical trial within 30 days of the enrolment visit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Subjective comfort, rated using a 100-point Visual Analog Scale (VAS) after 2, 4, 6 and 8 hours of wear 2. Tear film components, analysed from worn contact lenses at the end of the day | — |
Secondary
| Measure | Time frame |
|---|---|
| Contact lens tear film biophysical properties (pre-corneal tear film, tear prism digital video recording and tear film evaporimetry) measured at baseline visit | — |
Countries
United Kingdom
Contacts
Public ContactTrisha Patel
Outcome results
None listed