Condition category
Not Applicable
Date applied
21/02/2019
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
The purpose of this early feasibility study is to gain initial insights into the effects of an artificial tear drop whilst wearing contact lenses.

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

What does the study involve?
This study involves wearing soft contact lenses and using commercial rewetting drops for approximately six hours per day, five days per week for a total of four weeks. During this time you will be asked to attend 5 study visits on 4 to 5 separate days. The measurements taken throughout this study will be no different to those that should be conducted at a normal contact lens check-up visit.

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 July 2017 and is expected to run for approximately 3 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 Drive
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-17-07

Study information

Scientific title

Crossover evaluation of Clinitas Soothe eye drops in symptomatic soft contact lens wearers (Part 2)

Acronym

N/A

Study hypothesis

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

Ethics approval

Approved 07/04/2017, North West - Liverpool East Research Ethics Committee (Barlow House, 3rd Floor, 4 Minshull Street, Manchester, M1 3DZ; 02071048127), ref: 17/NW/0196.

Study design

Single site, bilateral, randomised, 2-week cross-over dispensing study
Participants will be randomised to the order of study product. Investigators and subjects will not be masked to the study product.

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

Habitual soft contact lenses will be worn and rewetting drops applied each day for a total of approximately four weeks. Two types of rewetting drops will be tested and participants will receive one of the rewetting drops to be used for the first two weeks and the other rewetting drop for the second two weeks, with a minimum of 3 days in between. Both types of rewetting drops are currently CE marked (i.e. approved for use in the European Union). All participants who agree to participate in this study will experience both types of rewetting drops, but the order in which they experience them will be decided at random (like flipping a coin).

Intervention type

Device

Phase

Drug names

Primary outcome measure

Measured at each of the 4 assessment visits:
1. Subjective comfort [1-100, in 1 unit steps] will be measured using a Visual Analog Scale.
2. Average comfortable wearing time [Hrs:Mins] will be recorded by subjects.
3. Pre-lens Non-invasive break-up time (NIBUT) [s] will be measured using a Keeler Tearscope.

Secondary outcome measures

Measured at each of the 4 assessment visits:
1. Subjective dryness [1-100, in 1 unit steps] will be measured using a Visual Analog Scale.
2. Subjective vision quality overall [1-100, in 1 unit steps] will be measured using a Visual Analog Scale.
3. Treatment preference for comfort(1ST/2ND) [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

08/03/2017

Overall trial end date

17/10/2017

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 and multifocal 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

Approximately 20-30

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 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 a concurrent clinical trial or any clinical trial (other than CDRP-402 Part 1) in the last 14 days

Recruitment start date

28/06/2017

Recruitment end date

01/08/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

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

Sponsor information

Organisation

CooperVision, Inc. (USA)

Sponsor details

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

Sponsor type

Other

Website

www.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

There is no intent to publish.

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 West - Liverpool East Research Ethics Committee.