Subclinical inflammation of the ocular surface Eye Diseases
Conditions
Interventions
Twenty soft contact lens wearers were recruited and instructed to wear three different types of soft contact lens (for one week each) in random sequence, with a one week washout period in between each
Sponsors
The University of Manchester
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Legal age (18) and capacity to volunteer. 2. Understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent. 3. Willing and able to follow the protocol. 4. Agree not to participate in other clinical research for the duration of this study. 5. Current soft contact lens wearers i.e. they have worn soft contact lenses within the past six months. 6. Can be satisfactorily fitted with the study lens types. 7. Willing to comply with the wear schedule (at least six days per week and for at least eight hours per day). 8. Own a wearable pair of spectacles which, in the opinion of the investigator, provide adequate vision in each eye over the study contact lens.
Exclusion criteria
Exclusion criteria: 1. Ocular disorder which would normally contra-indicate contact lens wear. 2. Systemic disorder which would normally contra-indicate contact lens wear. 3. Topical medication such as eye drops or ointment. 4. Had cataract surgery. 5. Had corneal refractive surgery. 6. Any corneal distortion or have keratoconus. 7. Pregnant or lactating. 8. Currently on immunosuppressive medication 9. Any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear. 10. Any infectious disease which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or they have any immunosuppressive disease (e.g. HIV), or a history of anaphylaxis or severe allergic reaction. 11. Taken part in any other contact lens or care solution clinical trial or research within two weeks prior to starting this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) In vivo confocal microscopy: The density of presumed dendritic cells in the cornea, bulbar and upper and lower eyelid margin of the conjunctiva were calculated using a semi-automated software (CCMetrics, M.A.Dabbah, ISBE, The University of Manchester, UK). Additionally, the presence of white spots (presumably leukocytes) in the upper and lower eyelid margin areas was also quantified using the same software. 2) Tear film: Each tear sample was analysed for 13 different types of inflammatory cytokines (Human Inflammation Panel 13-plex, BioLegend®, UK) using a cytometric bead array technique. 3) Impression cytology: Each impression sample were stained with CD45 marker (leukocyte common antigen) (BioLegend, UK) and analysed using flow cytometry. Tests carried out at baseline and after one week (7 days) of wearing each of the study lens-solution combination. | — |
Secondary
| Measure | Time frame |
|---|---|
| Association between the subclinical inflammation parameters with ocular comfort all visits (dispensing and follow-up) was statistically analysed. | — |
Countries
United Kingdom
Contacts
Public ContactNoor Haziq Saliman
Outcome results
None listed