Phase I trial: Ocular Technology Group International CV23-08

ISRCTN ISRCTN66819383
DOI https://doi.org/10.1186/ISRCTN66819383
IRAS number 327300
Secondary identifying numbers CV23-08, IRAS 327300
Submission date
25/01/2024
Registration date
26/01/2024
Last edited
26/01/2024
Recruitment status
No longer recruiting
Overall study status
Deferred
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

The Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended.

Contact information

Dr Michel Guillon
Scientific, Principal Investigator

66 Buckingham Gate
London
SW1E 6AU
United Kingdom

Phone +44 (0)207 222 4224
Email mguillon@otg.co.uk
Miss Deborah Moore
Public

66 Buckingham Gate
London
SW1E 6AU
United Kingdom

Phone +44 (0)207 222 4224
Email dmoore@otg.co.uk

Study information

Study designNon-dispensing prospective single-arm study
Primary study designInterventional
Secondary study designNon randomised study
Study setting(s)Other
Study typeOther
Participant information sheet Not available in web format
Scientific titlePhase I trial: Ocular Technology Group International CV23-08 [The full scientific title will be published within 30 months after the end of the trial]
Study objectivesThe Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trail has ended.
Ethics approval(s)

Approved 22/05/2023, South East Scotland Research Ethics Committee 2 (2nd Floor, Waverley Gate, 2-4 Waterloo Place, Edinburgh, EH1 3EG, United Kingdom; +44 (0)131 536 9000; ruth.fraser4@nhslothian.sct.nhs.uk), ref: 23/SS/0052

Health condition(s) or problem(s) studiedThe Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended.
InterventionThe Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended.
Intervention typeDevice
Pharmaceutical study type(s)Not Applicable
PhasePhase I
Drug / device / biological / vaccine name(s)The Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended.
Primary outcome measureThe Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended.
Secondary outcome measuresThe Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended.
Overall study start date01/02/2023
Completion date01/02/2025

Eligibility

Participant type(s)Healthy volunteer
Age groupAdult
Lower age limit40 Years
Upper age limit90 Years
SexBoth
Target number of participants40
Key inclusion criteriaThe Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended.
Key exclusion criteriaThe Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended.
Date of first enrolment01/02/2024
Date of final enrolment01/02/2025

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Ocular Technology Group International
66 Buckingham Gate
London
SW1E 6AU
United Kingdom

Sponsor information

CooperVision International Ltd
Industry

Delta Park
Concorde Way
Segensworth North
Fareham
PO15 5RL
England
United Kingdom

Phone +1 (0)925 251 6682
Email plazon@coopervision.com

Funders

Funder type

Industry

CooperVision
Government organisation / For-profit companies (industry)
Alternative name(s)
CooperVision, Inc., CooperVision Inc, CooperVision Inc., CooperVision, Inc
Location
United States of America

Results and Publications

Intention to publish date01/02/2027
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot expected to be made available
Publication and dissemination planFull trial details will be published up to 30 months after the end of the trial. Publication of some trial details is deferred because of the high commercial sensitivity of this phase I study and the negligible benefit to the public of phase I information. Results will be posted on or after the date of publication of full trial details.
IPD sharing planThe datasets generated and/or analysed during the current study are not expected to be made available because of their high commercial sensitivity and the negligible benefit to the public of publication of results of non-therapeutic clinical trials.

Editorial Notes

25/01/2024: Study's existence confirmed by the HRA.