Condition category
Not Applicable
Date applied
20/02/2019
Date assigned
01/03/2019
Last edited
08/03/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
This is an early feasibility study to gain preliminary insights into the retention time of a commercial eyedrop in contact lens wearers.

Who can participate?
Healthy, adapted contact lens wearers 18 years of age and older are eligible to participate.

What does the study involve?
Following a screening appointment to confirm eligibility, all eligible study participants will be asked to instill two different commercial eye drops with their contact lenses using three different regimens (i.e. one to four times per day at different time points during the day), on three different days. Each study day will be separated by a minimum of 1 day and a maximum of 10 days.

What are the possible benefits and risks of participating?
There might not be direct benefits to the participants in this study. However, participation may contribute to scientific research information that may be used in the development of new contact lens products. The risks to participants in this study are similar to those associated with normal daily wear of soft contact lenses.

Where is the study run from?
This study will be run at one site: Visioncare Research Clinic in Farnham, United Kingdom.

When is the study starting and how long is it expected to run for?
The study is planned to start in June 2017 and is expected to run for approximately 2 months.

Who is funding the study?
The study is funded by CooperVision, Inc.

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

Trial website

N/A

Contact information

Type

Scientific

Primary contact

Dr Nancy Keir

ORCID ID

Contact details

5870 Stoneridge Dr
Suite 1
Pleasanton
94588
United States of America
925-730-6768
nkeir@coopervision.com

Additional identifiers

EudraCT number

N/A

ClinicalTrials.gov number

N/A

Protocol/serial number

CV-16-58

Study information

Scientific title

Crossover evaluation of Clinitas Soothe® eye drops in symptomatic
soft contact lens wearers (part 1)

Acronym

N/A

Study hypothesis

The test product will provide non-inferior subjective comfort and pre-lens tear stability compared to the control product.

Ethics approval

Approved 12/06/2017, North East - Newcastle & North Tyneside 1 Research Ethics Committee (Jarrow Business Centre, Rolling Mill Road, Jarrow, NE32 3DT; 0207 104 8117), ref: 17/NE/0094.

Study design

Single site, 3-day, contralateral, randomised, single-masked, early feasibility study.
The order of the study products will be determined randomly.

Primary study design

Interventional

Secondary study design

Randomised cross over trial

Trial setting

Other

Trial type

Other

Patient information sheet

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

Condition

N/A

Intervention

This was a feasibility study to evaluate the retention time of a polymer on the eye in order to provide insights into new product development programs. Each commercial eyedrop was used by all subjects according to three different regimens/schedules. The regimens/schedules were assigned randomly over three study days. Each study day was separated by a minimum of 1 day and a maximum of 10 days.

Intervention type

Device

Phase

Drug names

Primary outcome measure

Measured on each study day:
1. Monocular comfort [1-100, in 1 unit steps] will be measured using a Visual Analog Scale.
2. Pre-lens Non-invasive break-up time (NIBUT) [s] will be measured using a Keeler Tearscope.

Secondary outcome measures

Measured on each study day:
1. Subjective dryness [1-100, in 1 unit steps] will be measured using a Visual Analog Scale.
2. Subjective vision quality [1-100, in 1 unit steps] will be measured using a Visual Analog Scale.
3. Lens preference for comfort [R/L, Likert 1-5] will be measured using a Likert Scale.
4. Ocular health (limbal hyperaemia and corneal staining) will be measured using a slit lamp microscope.

Overall trial start date

15/02/2017

Overall trial end date

07/08/2017

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. ≥18 years of age
2. Adapted and current symptomatic soft CL wearers (i.e. >1 month of wear)
3. Spherical spectacle prescription between +6.00 and -10.00D (inclusive)
4. Correctable to 6/12 (20/40) or better in each eye
5. Require visual correction in both eyes (monovision allowed but no monofit)
6. Have normal eyes with no evidence of any ocular abnormality or disease.

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

10-15

Total final enrolment

15

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 edema, corneal vascularisation, tarsal abnormalities, bulbar hyperemia, limbal hyperemia, 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. Has 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 in last 14 days.

Recruitment start date

16/06/2017

Recruitment end date

01/07/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Visioncare
Craven House, Arundell Place, West Street
Farnham
GU9 7EN
United Kingdom

Sponsor information

Organisation

CooperVision Inc. (USA)

Sponsor details

5870 Stoneridge Drive
Pleasanton
94588
United States of America
925-730-6768
nkeir@coopervision.com

Sponsor type

Other

Website

http://coopervision.com

Funders

Funder type

Industry

Funder name

CooperVision, Inc.

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

No publication is intended for this early feasibility trial.

IPD sharing statement: there are no plans for publication or to make the dataset available.

Intention to publish date

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

08/03/2019: Internal review. 01/03/2019: Trial's existence confirmed by the North East - Newcastle & North Tyneside 1 Research Ethics Committee.