ISRCTN - ISRCTN16230269: Evaluation of two different eye drops in symptomatic soft contact lens wearers

Plain English Summary

Background and study aims
The aim of this study is to compare the performance of two artificial tear drops whilst wearing contact lenses. Both types of drop have been CE marked which means they are approved for use in the UK and are commercially available.

Who can participate?
People who currently wear contact lens correction and who are aged 18 years or older

What does the study involve?
The study comprises five scheduled visits across four to five separate days, covering a total duration of about one month. Participants wear their normal brand and prescription of contact lenses during the study. These are supplied free of charge for the month in which they are participating in the study. Participants also test two types of artificial tears, receiving one of the artificial tears for the first two weeks and the other artificial tears for the second two weeks. Both types of artificial tears are currently CE marked (i.e. approved for use in the European Union) and are tested to see how the artificial tears perform in comparison to each other across two weeks of use. All participants use both types of artificial tears, but the order in which they experience them is decided at random (like flipping a coin). Participants who normally use rewetting drops when wearing contact lenses need to stop using them for the duration of the days of the study.

What are the possible benefits and risks of participating?
The artificial tears are designed to make wearing contact lenses more comfortable, but there is no guarantee that this study will help. The artificial tears might not improve your comfort or your comfort might get worse. Information from this study may help researchers come up with new treatments to help others in the future. As the artificial tears are CE-marked, the risks from participating in this study are very low. All contact lens wear or lens care products, however, can carry a risk of serious injury to the eye. Participants should take particular care to follow the instructions from the investigator, especially if the study involves a different lens care regime to their normal one.

Where is the study run from?
VisionCare Research (UK)

When is the study starting and how long is it expected to run for?
May 2018 to April 2019

Who is funding the study?
CooperVision, Inc. (USA)

Who is the main contact?
Dr Nancy Keir
nkeir@coopervision.com

Trial website

Contact information

Type

Scientific

Primary contact

Dr Nancy Keir

ORCID ID

Contact details

5870 Stoneridge Dr.
Suite 1
Pleasanton
94588
United States of America
+1 (0)925 730 6768
nkeir@coopervision.com

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

CV-18-28

Study information

Scientific title

Crossover evaluation of two different eye drops in symptomatic soft contact lens wearers

Acronym

Study hypothesis

The test eye drops will provide non-inferior subjective comfort and tear film stability compared to the control eye drops.

Ethics approval

Health Research Authority, North East - Newcastle & North Tyneside 1 Research Ethics Committee (NHSBT Newcastle Blood Donor Centre, Holland Drive, Newcastle upon Tyne, NE2 4NQ; Tel: +44(0)207 1048084; Email: nrescommittee.northeast-newcastleandnorthtyneside1@nhs.net), REC ref: 18/NE/0351

Study design

Early feasibility randomised bilateral 4-week (2 x 2-week) cross over dispensing study

Primary study design

Interventional

Secondary study design

Randomised cross over trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

Contact lens discomfort

Intervention

Symptomatic contact lens wearers will attend a screening, baseline visit then lens fit and follow-up visits for each 2 week part and there will be a minimum of 3 days between parts. In each part the subject will be fitted and issued with new (habitual brand) contact lenses in conjunction with either test or control drops before returning at 2 weeks for assessment. Subjects will be asked to respond to text questions at intervals for the duration of the study. Subjects will be randomised to the order of treatment (T/C or C/T). A random number generator (Microsoft Excel) will determine the randomisation of treatments to subjects, which is then incorporated into the Randomisation Log. To facilitate masking, the test products will be over-labelled and coded ‘A’ or ‘B’. Investigators will be masked to treatment product codes but not to the identity of the treatment products. Subjects will be masked to treatment product codes and the identity of the treatment products. The test eye drop is Clinitas Soothe Multi (Altacor) and the control eye drop is VisuXL (VISUfarma). Subjects will be requested to wear their contact lenses for at least 6 hours per day 5 days per week.
One drop from the over-labelled Test or Control product is to be applied to each eye according to the following insertion schedule.
Application 1: To the contact lens back surface upon removal from the storage case and just prior to insertion
Application 2: One drop to the lower fornix of each eye after 3 hours wear
Application 3: One drop to the lower fornix of each eye after 6 hours wear
Application 4: One drop to the lower fornix of each eye just after contact lens removal

Intervention type

Other

Phase

Drug names

Primary outcome measure

Measured at baseline and after 2 weeks for each cross-over phase:
1. Binocular subjective comfort measured using a visual analogue scale, 1-100, in 1 unit steps
2. Treatment preference for comfort (1st/2nd) measured using Likert scale, 1-5
3. Pre-lens non-invasive break-up time (NIBUT) measured using a tearscope in seconds

Secondary outcome measures

Measured at baseline and after 2 weeks for each cross-over phase:
1. Average and comfortable wearing time, measured using verbal report (Hrs Mins)
2. Subjective dryness measured using visual analogue scale, 1-100, in 1 unit steps
3. Subjective vision quality overall measured using visual analogue scale, 1-100, in 1 unit steps
4. Limbal and bulbar hyperaemia (graded 0-4) measured using slit lamp biomicroscopy
5. Corneal staining by quadrant for type (graded 0-4 scale); area (0-10) measured using slit lamp biomicroscopy

Overall trial start date

29/05/2018

Overall trial end date

16/04/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Subjects will be defined as symptomatic contact lens wearers if they present with at least one of the following two criteria at baseline:
1. Difference in reported wearing time and comfortable wearing time >2 hours
2. Score ≥14 by CLDEQ-8

All subjects must satisfy the following conditions prior to enrolling in the study:
1. Be ≥18 years of age
2. Able to read, comprehend and sign an informed consent
3. Willing to comply with the wear and study assessment schedule
4. Adapted and current symptomatic soft CL wearers (i.e. >1 month of wear)
5. Spherical spectacle prescription between +6.00 and -10.00D (inclusive)
6. Correctable to 6/12 (20/40) or better in each eye
7. Require visual correction in both eyes (monovision and multifocal allowed but no monofit)
8. 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:
8.1. Clear central corneas
8.2. No anterior segment disorder
8.3. No amblyopia
8.4. No strabismus
8.5. No evidence of lid abnormality or infection
8.6. No conjunctival abnormality or infection that would contraindicate contact lens wear
8.7. No clinically significant slit lamp findings (i.e. corneal oedema, staining, central scarring, infiltrates, active neovascularisation)
8.8. No other active ocular disease or recent surgery

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

Approximately 20 (maximum 30)

Participant exclusion criteria

1. Previously shown sensitivity to any of the study solutions’ components
2. Any systemic or ocular disease or allergies affecting ocular health
3. Using systemic or topical medications that will, in the investigator’s opinion, affect ocular physiology or lens performance
4. Clinically significant (>Grade 3) corneal stromal oedema, corneal vascularisation, tarsal abnormalities, bulbar hyperaemia, limbal hyperaemia, or any other abnormality of the cornea that would contraindicate contact lens wear
5. Any corneal infiltrates or any corneal scarring or neovascularization within the central 5mm of the cornea
6. Keratoconus or other corneal irregularity
7. Aphakia or amblyopia
8. Diabetes
9. Known/reported infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV)
10. History of chronic eye disease (e.g. Glaucoma or ARMD)
11. Pregnant or lactating or planning a pregnancy at the time of enrolment
12. Participation in any concurrent clinical trial or any clinical trial in the last 14 days

Recruitment start date

09/11/2018

Recruitment end date

01/03/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

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

Sponsor information

Organisation

CooperVision, Inc.

Sponsor details