ISRCTN - ISRCTN14481675: Clinical evaluation of Ocutec daily disposable contact lenses

Plain English Summary

Background and study aims
There are different kinds of vision problems that are difficult to correct by wearing glasses or contact lenses. Hyperopia, or farsightedness, is a common vision problem affecting about a quarter of the population. People who are farsighted can see far away objects well but have difficulty focusing on objects up close. This can cause headaches or eyestrain. Near sightedness, or myopia, is the most common condition of the eye. Near sighted people have difficulty reading road signs and seeing far away objects clearly, but are able to see well for close up tasks such as reading and computer use. This can cause squinting, eyestrain and headaches and fatigue while driving or playing sports. The Ocutec family of contact lenses are designed to fix both near and far sightedness. Ocutec’s new contact lens, the Ocutec PEG lens, is based on a new material that is made to improve the quality of the contact lens wearing experience, provide a healthier lens and improve eyesight. The aim of this study is to compare Ocutec’s lens with an established brand, assessing the comfort, vision and fit of the lenses.

Who can participate?
Adults contact lens wearers who require visual correction in both eyes

What does the study involve?
Participants are given two different types of contact lenses to wear in their eyes for 8 hours, either Ocutec’s PEG or an existing contact lens (Acuvue OASYS ®). Participants are randomly allocated to see which of their eyes wear each type of contact lens. Participants are assessed twice during the study duration. The first follow-up visit measures how well the contact lenses are working, feeling and fitting after 30 minutes and the second follow-up visit measures how well the contact lenses are working, feeling and fitting after 8 hours of wear. Participants receive standard contact lens care before they put the contact lens in and during their follow-up assessments.

What are the possible benefits and risks of participating?
There are no direct benefits to participants. There are general risks of wearing daily contact lenses however as they are worn for a short amount of time in this study the risks are not significant.

Where is the study run from?
Visioncare Research Clinic (UK)

When is the study starting and how long is it expected to run for?
January 2017 to May 2017

Who is funding the study?
Ocutec Ltd (UK)

Who is the main contact?
Mr Graeme Beaton
graeme.beaton@ocutec.com

Trial website

Contact information

Type

Public

Primary contact

Mr Graeme Beaton

ORCID ID

Contact details

3 Clark Way
Bellshill
ML4 3NX
United Kingdom
+44 (0)1698 849876
graeme.beaton@ocutec.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PEGA-2804

Study information

Scientific title

One-day clinical evaluation of a PEG cast-moulded soft contact lens

Acronym

Study hypothesis

The aim of this study is to assess the clinical performance of PEG spherical soft lenses in comparison with a control soft contact lens.

Ethics approval

London – Hampstead Research Ethics Committee, 08/03/2017, REC ref: 17/LO/0400, protocol number: PEGA 2804, IRAS Project No. 222858

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

Condition

Myopia and hyperopia

Intervention

Participants are given contact lenses to wear contralaterally for 8 hours. Participants are instructed to wear either a Ocutec PEG spherical soft lenses in one eye and a control soft contact lens Acuvue OASYS® in the other eye. The eye to which each lens is worn is assigned randomly. A random number generator (Microsoft Excel) determines the randomisation of lenses to subjects, which is then incorporated into the Randomisation Log. ID numbers (a six-digit code, made up of the study identifier (PG), the two-digit subject enrolment number and the initial letters of their first and last names) is assigned consecutively to maintain randomisation.

Visit 1: Participants are assessed at baseline and receive standard contact lens care (eye examination and measurements). Participants are then given the contact lens to wear and they insert them in their eyes. Lenses are allowed to settle for a minimum of 10 minutes prior for initial assessment of fit, comfort and for vision. Participants have two follow up visits during the study. After the lens fit the subjects remain in the clinic until the 30 minutes post insertion for their first follow up. After 30 minutes of wear, participants are assessed for comfort, lens preference, vision, lens surface and lens fit. Participants must show acceptable lens fit with both lenses and must be corrected to 0.20 logMAR (6/9) or better for binocular distance VA (over-spectacle correction may be used if required). If the lenses do not display suitable fitting, or the subject is unable to achieve 0.20 logMAR or better distance VA then they are discontinued from the study and an Exit form is completed. The Participant Instruction Guide is provided to all subjects which contains instructions regarding lens wear. The Investigator or a clinical assistant reviews instructions and warnings for lens wear and other important issues with the participant. Participants who appear unable or unwilling to follow instructions to a degree that, in the Investigator’s opinion, jeopardises the participant’s wellbeing or the validity of the study, are discontinued.

Visit 2: The 8-hour follow-up visit is scheduled 8 hours (±60 minutes) from the initial lens insertion time. The participants attend this visit having worn the study lenses continuously since Visit 1. If the participant has removed the lenses for any reason then the participant is exited from the study and the reason(s) are documented on the Exit Visit CRF. Participants are assessed for comfort, lens preference, vision, lens surface and lens fit as well as handle-ability upon removal of the lenses. Following this assessment, worn lenses are discarded on-site.

Participants are given a study exit form for when the study has finished. This includes the patients permanent record and the details of the study. Post-study follow-up visits are scheduled if the investigator judges they are necessary and therefore the exit forms are not given to those participants until after their extra follow up visits.

Intervention type

Device

Phase

Drug names

Primary outcome measure

1. Comfort is assessed by the subject is assessed by the subject at 30 minutes and 8 hours
2. High contrast VA is measured using computer-generated logMAR charts at 30 minutes and 8 hours
3. Non-invasive break-up time is measured using the Keeler Tearscope® and grid at 30 minutes and 8 hours
4. Pre-lens tear film quality is measured by slit lamp examination at 30 minutes and 8 hours
5. Overall lens fit is measured by slit lamp examination after at 30 minutes and 8 hours

Secondary outcome measures

1. Bulbar hyperaemia (0-4) is measured by Slit Lamp examination at 30 minutes and 8 hours or at another time if the subject is discontinued from the study early
2. Corneal staining (0-4) is measured by Slit Lamp examination at 8 hours or at another time if the subject is discontinued from the study early

Overall trial start date

20/01/2017

Overall trial end date

31/05/2017

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Be 18 years old and older and has 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. Willing to wear supplied over-spectacle correction if required
5. Be existing soft contact lens wearers (at least 4 weeks daily wear prior to study)
6. Require a visual correction in both eyes (monovision allowed but no monofit)
7. Have a spherical contact lens requirement in the range of -1.00D to -4.00D
8. Have no greater than 1.00D difference in contact lens spherical requirement between eyes
9. Have astigmatism <1.25D in both eyes
10. Monocular distance visual acuity correctable to 6/9 (20/30) or better in each eye with best sphero-cylindrical refraction
11. Have normal eyes with no evidence of any ocular abnormality or disease. For the purposes of this study a normal eye is defined as one having clear central corneas, no anterior segment disorder, no clinically significant slit lamp findings (i.e. corneal oedema, staining, central scarring, infiltrates, active neovascularisation) and no other active ocular disease or recent surgery.

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

Approximately 10-30 existing soft contact lens wearers with no evidence of ocular abnormality or disease contra-indicating contact lens wear will be dispensed lenses on this study.

Participant exclusion criteria

1. Any systemic disease affecting ocular health
2. Any systemic or topical medications that will in the investigator’s opinion affect ocular physiology or contact lens performance
3. Severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses
4. Persistent, clinically significant corneal or conjunctival staining using fluorescein dye (≥ Grade 3)
5. Aphakic
6. Undergone corneal refractive surgery
7. Participating in any other type of eye related clinical or research study
8. Pregnancy, lactating or planning a pregnancy at the time of enrollment
9. Participation in any trial within the last 14 days

Recruitment start date

14/02/2017

Recruitment end date

31/05/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Visioncare Research Clinic
Craven House West Street
Farnham
GU9 7EN
United Kingdom

Sponsor information

Organisation

Ocutec Ltd

Sponsor details

3 Clark way
Bellshill
ML4 3NX
United Kingdom
+44 (0)1698 849876
graeme.beaton@ocutec.com

Sponsor type

Industry

Website

Funders

Funder type