Extrait

Background and study aims Some people find wearing contact lenses can be uncomfortable, especially at the end of the day. At present, we do not know whether changes to the eye or to the contact lens are the most important factors in governing this discomfort. This project aims to improve our understanding in this area by assessing the effect of lens replacement and lens manipulation on the comfort of contact lenses. Who can participate? Adults who currently use daily disposable soft contact lenses and have used them for at least six months and have symptoms of discomfort at the end of the day What does the study involve? Volunteers will attend a clinic for six visits over four days. They will wear their habitual contact lenses during the course of the study. On day 1, volunteers will attend the clinic for an initial visit in which the investigator will confirm that they match the inclusion and exclusion criteria and will do an examination of the front surface of the eye. On days 2 and 3, volunteers will attend the clinic in the morning and 5 hours later. The investigator will randomly assign an intervention to each eye. In the morning, comfort scores will be collected before and after lens application. Volunteers will then leave the clinic and will be asked to wear their contact lenses in the normal way for at least 12 hours during which time they will provide comfort scores via SMS. Volunteers will return to the clinic 5 hours after lens application and the investigator will either replace the lens or manipulated the lens on-eye. The contact lens will not be manipulated in any way in the control group. Comfort scores will be collected at this time. Volunteers will then be asked to continue wearing their lenses and to provide comfort scores via SMS until they remove their lenses. On day 4, volunteers will attend the clinic for an exit visit in which they will receive an examination of the front surface of the eye and will then leave the study. What are the possible benefits and risks of participating? Benefits may include a thorough anterior eye examination and advice on contact lenses. All lens care products have the potential of causing serious injury to the eye. Due to the nature and duration of the study, the risks are judged to be similar to those of normal contact lens wear since subjects. It is possible that the following may occur with the use of contact lens products: pain, abrasion of the eyes, sensations of itching, burning or stinging, excessive tear production, unusual secretions, redness, reduced sharpness of vision, blurred vision, sensitivity to light or dry eyes. In rare instances, corneal ulcers, scarring, the growth of blood vessels into the cornea, temporary or permanent decreased vision, iritis and infections of the eye requiring treatment might occur. Major side effects from the use of diagnostic dye sodium fluorescein are very rare, but there are three reports of anaphylaxis following topical instillation of fluorescein. Anaphylaxis can result in death but none of the reported cases to date has been fatal. Other rare side effects from the topical use of sodium fluorescein can include slight stinging on instillation and temporary blurred vision. Where is the study run from? Eurolens Research at the University of Manchester (UK) When is the study starting and how long is it expected to run for? From February 2013 to March 2014 Who is funding the study? Investigator initiated and funded Who is the main contact? Miss Maria Navascues-Cornago

Critère d'inclusion

• Contact lens comfort

Liens

• ictrp
• isrctn