Plain English Summary
Background and study aims
The Ocutec family of contact lenses are designed for the correction of near and far sightedness. Hyperopia, or farsightedness, is a common vision problem, affecting about a quarter of the population. People with hyperopia can see distant objects very well, but have difficulty focusing on objects that are up close. Farsighted people sometimes have headaches or eyestrain and may squint or feel fatigued when performing work at close range. Near sightedness, or myopia, is the most common condition of the eye, and it has become more common in recent years. If you are near sighted, you typically will have difficulty reading road signs and seeing distant objects clearly, but will be able to see well for close-up tasks such as reading and computer use. Other signs and symptoms of myopia include squinting, eyestrain and headaches. Feeling fatigued when driving or playing sports also can be a symptom of uncorrected near sightedness. Ocutec’s lens is based on a new material that is designed to improve the quality of the contact lens wearing experience and provide a healthier lens. The aim of this study is to compare Ocutec’s lens with an established brand, assessing the comfort and fit of the lenses.
Who can participate?
Volunteers aged 18 or over who wear glasses or contact lenses.
What does the study involve?
Each participant wears an Ocutec lens in one eye and an established brand of lens in the other eye for a period of 8 hours and is assessed at three different times throughout the day: on inserting the lens, after 30 minutes wear and then again after 8 hours wear. All volunteers undergo the same assessments, testing the ease of handling of the lens, comfort, vision and the fit of the lens.
What are the possible benefits and risks of participating?
There may not be any direct benefits to the volunteers in this study, but the study may contribute to scientific research that could be used to develop new products. This is low risk study, based on international standards. The risk to volunteers is further reduced as the lenses are only on the eye for 8 hours and will be monitored closely by the investigator. Complications that may occur during the wear of the lens include discomfort, dryness, aching or itchy eyes, and blurred vision. There is also a small risk of infection, although contact lens related infections are very rare the possibility does still exist.
Where is the study run from?
Visioncare Research, Craven House, Surrey, UK.
When is the study starting and how long is it expected to run for?
November 2015
Who is funding the study?
Ocutec Ltd (UK)
Who is the main contact?
Dr Graeme Young
g.young@visioncare.co.uk
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2802-2803
Study information
Scientific title
Ocutec daily disposable contact lens comfort evaluation: a randomised double-masked contralateral study
Acronym
Study hypothesis
To assess the clinical performance of PEG and PEG silicone spherical soft lenses in comparison with a control soft contact lens.
Ethics approval
West of Scotland Research Ethics Service, 18/12/2015, ref: 15/WS/0244
Study design
One-day randomised double-masked contralateral study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Please see additional files
Condition
Myopia and hyperopia
Intervention
Each subject will wear a test lens in one eye and a control lens in the other for a period of 8 hours and will be assessed at three different time-points throughout the day: on insertion, after 30 minutes wear and then again at exit after 8 hours wear.
Subjective assessments: ease of handle-ability on insertion, monocular comfort on insertion.
Lens fit assessment: centration, corneal coverage, post blink movement, version lag, edge tightness, tightness on push up, diameter acceptance, overall fit acceptance, overall fit preference.
Lens surface assessment: wettability, non-invasive break-up time, pre-lens tear film quality, front surface deposits, surface preference.
Slit lamp assessment: bulbar conjunctival hyperaemia, limbal hyperaemia, tarsal hyperaemia.
Vision: monocular high and low contrast-distance visual acuity, spherical over-refraction, monocular high and low contrast VAs with over-refraction
Intervention type
Device
Phase
Drug names
Primary outcome measure
1. Overall comfort at the 8 hour visit
2. High contrast visual acuity with over-refraction at the 8 hour visit
3. Non-invasive break up time at the 8 hour visit
4. Lens wettability at the 8 hour visit
5. Overall fit acceptance at the 8 hour visit
All the outcome measure will be assesses using standard optometry equipment and metrology and patient interviews and observation.
Secondary outcome measures
1. Bulbar hyperaemia at the 8 hour visit
2. Corneal staining at the 8 hour visit
All the outcome measure will be assesses using standard optometry equipment and metrology and patient interviews and observation.
Overall trial start date
01/12/2015
Overall trial end date
07/01/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Be at least 18 years old and full legal capacity to volunteer
2. Read, understand and sign written statement of informed consent
3. Appears able and willing to follow instructions and maintain the appointment schedule
4. Existing soft contact lens wearer (at least 4 weeks daily wear prior to study)
5. Require a visual correction in both eyes (monovision allowed but no monofit)
6. Have a spherical contact lens requirement in the range of -1.00 to -4.00 DS
7. Have no greater than 1.00 DS difference in contact lens spherical requirements between eyes
8. Have astigmatism <1.25DC in both eyes
9. Monocular distance visual acuity correctable to 6/9 (20/40) or better in each eye best sphero-cylindrical refraction
10. Have normal eyes with no evidence of any ocular abnormality or disease. For the purpose of the study a normal eye is defined as having one of these:
10.1. Clear central cornea
10.2. No anterior segment disorder
10.3. No clinically significant slit lamp findings (corneal oedema, staining, central scarring, infiltrates, active neovascularisation)
10.4. No other active ocular disease or recent surgery
Participant type
Healthy volunteer
Age group
Adult
Gender
Both
Target number of participants
20-25
Participant exclusion criteria
1. Any systematic disease affecting ocular health
2. Any systemic or topical medications that will in the investigators opinion affect ocular physiology or contact lens performance
3. Have severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of the contact lenses
4. Has persistent, clinically significant corneal or conjuctival staining using fluorescein dye (> Grade 3)
5. Is aphakic
6. Has undergone corneal refractive surgery
7. Is participating in any other type of eye-related clinical or research study
8. Pregnancy, lactating or planning a pregnancy at the time of enrolment
Recruitment start date
01/12/2015
Recruitment end date
07/01/2016
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Visioncare Research
Craven House
West Street
Farnham
GU9 7EN
United Kingdom
Sponsor information
Organisation
Ocutec Ltd (UK)
Sponsor details
3 Clark Way
Bellshill
ML4 3NX
United Kingdom
Sponsor type
Research organisation
Website
Funders
Funder type
Industry
Funder name
Ocutec Ltd (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
No publications expected
Intention to publish date
Participant level data
Available on request
Basic results (scientific)
Publication list
Publication citations
Additional files
- ISRCTN25271353_PIS.docx 13/04/2016