Short-term evaluation of a commercial eyedrop in contact lens wearers

ISRCTN ISRCTN11194798
DOI https://doi.org/10.1186/ISRCTN11194798
EudraCT/CTIS number N/A
ClinicalTrials.gov number N/A
Secondary identifying numbers CV-16-58
Submission date
20/02/2019
Registration date
01/03/2019
Last edited
08/03/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

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

Study website

Contact information

Dr Nancy Keir
Scientific

5870 Stoneridge Dr, Suite 1
Pleasanton
94588
United States of America

Phone 925-730-6768
Email nkeir@coopervision.com

Study information

Study designSingle site, 3-day, contralateral, randomised, single-masked, early feasibility study. The order of the study products will be determined randomly.
Primary study designInterventional
Secondary study designRandomised cross over trial
Study setting(s)Other
Study typeOther
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titleCrossover evaluation of Clinitas Soothe® eye drops in symptomatic soft contact lens wearers (part 1)
Study acronymN/A
Study objectivesThe test product will provide non-inferior subjective comfort and pre-lens tear stability compared to the control product.
Ethics approval(s)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.
Health condition(s) or problem(s) studiedN/A
InterventionThis 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 typeDevice
Pharmaceutical study type(s)
Phase
Drug / device / biological / vaccine name(s)
Primary outcome measureMeasured 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 measuresMeasured 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 study start date15/02/2017
Completion date07/08/2017

Eligibility

Participant type(s)Healthy volunteer
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants10-15
Total final enrolment15
Key inclusion criteria1. ≥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.
Key exclusion criteria1. 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.
Date of first enrolment16/06/2017
Date of final enrolment01/07/2017

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

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

Sponsor information

CooperVision Inc. (USA)
Other

5870 Stoneridge Drive
Pleasanton
94588
United States of America

Phone 925-730-6768
Email nkeir@coopervision.com
Website http://coopervision.com

Funders

Funder type

Industry

CooperVision, Inc.

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot expected to be made available
Publication and dissemination planNo publication is intended for this early feasibility trial.
IPD sharing planThere are no plans for publication or to make the dataset available.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
HRA research summary 28/06/2023 No No

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.