Phase I trial: Ocular Technology Group International CV23-38
| ISRCTN | ISRCTN48624267 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN48624267 |
| IRAS number | 342156 |
| Secondary identifying numbers | ID23-37 CV23-38 |
- Submission date
- 20/11/2024
- Registration date
- 26/11/2024
- Last edited
- 26/11/2024
- 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
Scientific, Principal Investigator
Scientific, Principal Investigator
66 Buckingham Gate
LONDON
SW1E 6AU
United Kingdom
| Phone | +44 2072224224 |
|---|---|
| MGuillon@otg.co.uk |
Miss Deborah Moore
Public
Public
66 Buckingham Gate
LONDON
SW1E 6AU
United Kingdom
| Phone | +44 2072224224 |
|---|---|
| dmoore@otg.co.uk |
Study information
| Study design | Non dispensing bilateral randomized study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | Other |
| Study type | Other |
| Participant information sheet | No participant information sheet available |
| Scientific title | Phase I trial: Ocular Technology Group International CV23-38 [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 13/06/2024, South East Scotland Research Ethics Committee 02 (2nd Floor, Waverley Gate 2-4 Waterloo Place, Edinburgh, EH1 3EG, United Kingdom; +44 131 5369000; ruth.fraser4@nhslothian.scot.nhs.uk), ref: 24/SS/0049 |
| 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 |
| Pharmaceutical study type(s) | Not Applicable |
| 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 | 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. |
| Secondary outcome measures | 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. |
| Overall study start date | 13/06/2024 |
| Completion date | 29/10/2024 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 40 Years |
| Upper age limit | 90 Years |
| Sex | Both |
| Target number of participants | Up to 20 |
| Total final enrolment | 11 |
| 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 | 01/08/2024 |
| Date of final enrolment | 25/10/2024 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Ocular Technology Group International
66 Buckingham Gate
LONDON
SW1E 6AU
United Kingdom
LONDON
SW1E 6AU
United Kingdom
Sponsor information
CooperVision International Limited
Industry
Industry
5870 Stoneridge Dr.
Pleasanton
CA 94588
United States of America
| Phone | +1-925-251-6682 |
|---|---|
| PLazon@coopervision.com |
Funders
Funder type
Industry
CooperVision International Ltd.
No information available
Results and Publications
| Intention to publish date | 31/12/2030 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Full 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 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. |
Editorial Notes
26/11/2024: Trial's existence confirmed by NHS HRA.
