Management of soft contact lens wearing symptoms Eye Diseases
Conditions
Interventions
The participants were refitted with a daily disposable contact lens, half in the control group were managed as per conventional routine practice and the other half in the test group received enhanced
Sponsors
CooperVision (United States)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 18 to 40 years 2. Current daily wear soft contact lens wearer who have worn contact lenses for at least six months in total 3. CLDEQ-8 =14 and/or comfortable wearing time = 9hrs; with selfreported end of day dryness or discomfort 4. Spectacle refraction: Sphere: -6.00D to + 4.00D Astigmatism: 0.00D to -0.75 5. Best corrected visual acuity of at least 20/30 in each eye 6. No significant ocular signs that would prohibit contact lens wear including: 6.1. Blepharitis score <3 (0 to 4-point scale) 6.2. Meibomian gland score <3 (0 to 4-point scale) 6.3. Corneal staining score <7 (0 to 10-point scale) 6.4. Conjunctival staining score <3 on (0 to 4-point scale) 6.5. TPH without contact lenses =0.125 mm 6.6. OSDI score without contact lenses <13 7. Have read and understood the Participant Information Sheet in English 8. Have read, signed and dated the Informed Consent 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. Monocular participants (only one eye with functional vision) or participants fit with only one lens 3. Any moderate or severe ocular condition observed during the slit-lamp examination at the enrolment visit 4. History of herpetic keratitis, ocular surgery or irregular cornea 5. Known pregnancy or lactation during the study period as determined by self-report 6. 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 7. Individuals who are unable to read or understand the Participant Information Sheet in English
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Contact lens overall comfort measured using the CLDEQ8 questionnaire overall score at 1, 3, 6 and 12 months 2. Contact lens wearing time (hours) measured using self report at 1, 3, 6 and 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Contact lens comfort at different times of the day measured using 100 point Visual Analogue scale at 1, 3, 6 and 12 months | — |
Countries
United Kingdom
Contacts
Public ContactDeborah Moore
Outcome results
None listed