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Effect of contact lens replacement and manipulation on comfort

Effect of three interventions on contact lens comfort in symptomatic wearers: a randomised single-blind study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN10419752
Enrollment
30
Registered
2015-02-16
Start date
2013-08-21
Completion date
Unknown
Last updated
2023-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contact lens comfort Eye Diseases Contact lens comfort

Interventions

Subjects will attend the clinic on two study days. On each day, subjects attended the clinic in the morning without any lenses in situ (and not having worn lenses beforehand on the day). A new pair of
subjects will then be asked to fully blink five times, and then the lens will be slid back onto the cornea 4. No action (control): the contact lens will not be manipulated in any way

Sponsors

University of Manchester
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. At least 18 years old and capacity to volunteer 2. Understand rights as a research subject 3. Willing and able to ?sign a statement of informed consent 4. Willing and able to follow the protocol 5. Agree not to participate in other clinical research for the duration of this study 6. Wear daily disposable soft contact lenses and have worn them for at least 6 months 7. Symptomatic according to method by Young et al (Characterizing contact lens-related dryness symptoms in a cross-section of UK soft lens wearers. Contact Lens and Anterior Eye 2011; 34: 64–70) 8. Willing to wear contact lenses for at least 12 hours a day 9. Having a mobile phone

Exclusion criteria

Exclusion criteria: 1. Systemic or ocular disorder that might affect ocular health 2. Grade 2 or greater of any anterior ocular clinical signs 3. Use of any topical medication, such as eye drops or ointment 4. Previous cataract or corneal refractive surgery 5. Corneal distortion resulting from previous hard or rigid lens wear or keratoconus 6. Pregnant or lactating 7. Diabetes 8. Infectious disease (e.g., hepatitis) 9. Immunosuppressive disease (e.g., HIV) 10. History of severe allergic reaction or anaphylaxis (a serious form of hypersensitivity that can, in rare cases, result in death) 11. Unacceptable lens fit (grade –2 or +2 on a –2 to +2 grading scale) 12. Participation in other clinical trial or research within 2 weeks before starting this study

Design outcomes

Primary

MeasureTime frame
1. Contact lens comfort score will be measured with an annotated vertical analogue comfort scale of 0 (causes pain, cannot be tolerated) and 100 (excellent, cannot be felt) and recorded on paper before lens application, 5 hours post-application, and 6 minutes post-intervention 2. Comfort scores at 6 minutes post-application and at every hour following lens application will be collected through SMS messaging using the same scale; only SMS comfort scores received within 30 minutes from the target time will be included in the analysis

Countries

England, United Kingdom

Contacts

Public ContactMaria Navascues-Cornago

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 4, 2026