Phase I trial: Ocular Technology Group International

ISRCTN	ISRCTN31669765
DOI	https://doi.org/10.1186/ISRCTN31669765
Integrated Research Application System (IRAS)	363818
Sponsor	CooperVision International Limited
Funder	CooperVision

Submission date: 16/03/2026
Registration date: 18/03/2026
Last edited: 18/03/2026

Recruitment status: No longer recruiting
Overall study status: Deferred
Condition category: Eye Diseases

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

Prof Michel Guillon
Principal investigator

66 Buckingham Gate
London
SW1E 6AU
United Kingdom

Phone	+44 (0)2072224224
Email	mguillon@otg.co.uk

Ms Deborah Moore
Public

66 Buckingham Gate
London
SW1E 6AU
United Kingdom

Phone	+44 (0)7015665390
Email	dmoore@otg.co.uk

Prof Michel Guillon
Scientific

OTG LTD
66 Buckingham Gate
London
SW1E 6AU
United Kingdom

Phone	+44 (0)2072224224
Email	mguillon@otg.co.uk

Study information

Primary study design	Interventional
Allocation	Randomized controlled trial
Masking	Open (masking not used)
Control	Active
Assignment	Crossover
Purpose	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.
Scientific title	Phase I trial: Ocular Technology Group International [The full scientific title will be published within 30 months after the end of the trial]
Study objectives	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.
Ethics approval(s)	Approved 21/11/2025, North Scotland Research Ethics Committee 01 (Summerfield House, 2 Eday Road, Aberdeen, AB15 6RE, United Kingdom; Not available; gram.nosres@nhs.scot), ref: 25/NS/0122
Health condition(s) or problem(s) studied	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.
Intervention	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.
Intervention type	Device
Phase	Phase 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 measure(s)	[Outcome name] measured using [Metric or method of measurement] at [Timepoint(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.
Key secondary outcome measure(s)
Completion date	30/09/2026

Eligibility

Participant type(s)
Age group	Mixed
Lower age limit	40 Years
Upper age limit	80 Years
Sex	All
Target sample size at registration	25
Key inclusion criteria	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.
Key exclusion criteria	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.
Date of first enrolment	20/03/2026
Date of final enrolment	31/07/2026

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Ocular Technology Group International

66 Buckingham Gate
London
SW1E 6AU
England

Results and Publications

Individual participant data (IPD) Intention to share	No

Editorial Notes

16/03/2026: Study's existence confirmed by North Scotland Research Ethics Committee 01.