Investigation of eye response to two different contact lens solutions

Not Applicable

Completed

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

• Registration Number: ISRCTN17082971
• Lead Sponsor: The University of Manchester

Brief Summary

2020 results in https://pubmed.ncbi.nlm.nih.gov/31725697/ (added 21/05/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2018-01-31
• Study Start: 2019-03-21
• Last Update Posted: 7 June 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. 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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified