Phase I trial: Ocular Technology Group International
| ISRCTN | ISRCTN90702227 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN90702227 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 326886 |
| Protocol serial number | IRAS 326886, ID23-11A CV23-07 |
| Sponsor | CooperVision International Limited |
| Funder | Cooper Vision International Ltd |
- Submission date
- 07/08/2023
- Registration date
- 15/08/2023
- Last edited
- 15/08/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Deferred
- Condition category
- Other
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
Principal investigator
66 Buckingham Gate
London
SW1E 6AU
United Kingdom
| Phone | +44 (0)20-7222-4224 |
|---|---|
| MGuillon@otg.co.uk |
Public
66 Buckingham Gate
London
SW1E 6AU
United Kingdom
| Phone | +44 (0)20-7222-4224 |
|---|---|
| DMoore@otg.co.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Non dispensing prospective, contralateral study design in 20 participants |
| Secondary study design | Randomised cross over trial |
| Study type | Participant information sheet |
| 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 22/05/2023, South East Scotland Research Ethics Committee 02 (2nd Floor, Waverley Gate 2-4 Waterloo Place., Edinburgh, EH1 3EG, United Kingdom; 01315369000; ruth.fraser4@nhslothian.scot.nhs.uk), ref: 23/SS/0051 |
| 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) |
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) |
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. |
| Completion date | 31/12/2023 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Mixed |
| Lower age limit | 40 Years |
| Upper age limit | 90 Years |
| Sex | All |
| Target sample size at registration | 20 |
| 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 | 30/06/2023 |
| Date of final enrolment | 01/09/2023 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
London
SW1E 6AU
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan | The 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
11/08/2023: Trial's existence confirmed by Lothian NHS Board (UK).
