An investigation of the inflammatory response in soft contact lens wear

Not Applicable

Completed

• Conditions: Eye Diseases; Subclinical inflammation of the ocular surface

• Registration Number: ISRCTN55788739
• Lead Sponsor: The University of Manchester

Brief Summary

2020 results in https://pubmed.ncbi.nlm.nih.gov/31725697/ (added 29/03/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2017-06-30
• Study Start: 2019-03-21
• Last Update Posted: 12 April 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified