Subclinical inflammation of the ocular surface Eye Diseases
Conditions
Interventions
Fifteen soft contact lens wearers were recruited and instructed to wear two different types of soft contact lens and no lens wear (control) for one week, 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. Understand the use of the care solutions and willing to comply with the instruction given in this study. 9. Own a wearable pair of spectacles which, in the opinion of the investigator, provide adequate vision in each eye.
Exclusion criteria
Exclusion criteria: 1. Ocular disorder which would normally contra-indicate contact lens wear or the care solutions used in the study. 2. Systemic disorder which would normally contra-indicate contact lens wear or the care solutions used in the study. 3. Topical medication such as eye drops or ointment. 4. Cataract surgery. 5. Corneal refractive surgery. 6. Corneal distortion or have keratoconus. 7. Pregnant or lactating. 8. Currently on immunosuppressive medication. 9. Ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear. 10. 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. Impression cytology: Each impression sample were stained with antibody markers, CD45 (leukocyte common antigen), CD3 (T cells) and CD11c (dendritic cells) (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 and ocular comfort at each follow-up visit was statistically analysed. | — |
Countries
United Kingdom
Contacts
Public ContactNoor Haziq Saliman
Outcome results
None listed