Proactive management to understand contact lens wearers success

Not Applicable

Completed

• Conditions: Management of soft contact lens wearing symptoms; Eye Diseases

• Registration Number: ISRCTN11525595
• Lead Sponsor: CooperVision (United States)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-28
• Study Completion: 2021-05-01
• Last Update Posted: 2 August 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 81

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified