Clinical Evaluation of DP037, for contact lens users
| ISRCTN | ISRCTN28788224 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN28788224 |
| Secondary identifying numbers | MENP-2901 |
- Submission date
- 04/07/2012
- Registration date
- 13/07/2012
- Last edited
- 12/01/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Plain English summary of protocol
Background and study aims
The standard method of cleaning rigid gas permeable (RGP) contact lenses is to soak the lenses in a solution containing chemical disinfectant. Some disinfectants are highly effective against microorganisms but users are required to neutralize the solutions before wearing the lenses. However, disinfectant that is too strong may be toxic to the eye. The contact lens care product DP037 (Menicon) is a multi-purpose solution applicable to all RGP contact lenses and is intended for washing, disinfection, rinsing and storage of contact lenses. The purpose of this study is to compare DP037 (test solution) with another solution on the market (control solution).
Who can participate?
The participants involved in this study will be at least 18 years of age and selected on the basis of having healthy eyes, except for the need for vision correction. The participants need to have worn RGP contact lenses for at least 3 months prior to the study.
What does the study involve?
Participants randomly assigned to use either the test or the control solution for 3 months and given a new set of RGP contact lenses during the study. The participants will be required to attend for a maximum of five study visits. During those visits their eyes will be examined and asked to complete questionnaires.
What are the possible benefits and risks of participating?
The participants could potentially experience side effects or sensitivity to the ingredients in the lens care solution. Adverse reactions associated with RGP lenses and their care products include: eyes stinging, burning or itching (irritation), excessive watering (tearing) of the eyes, unusual eye secretions, redness of the eyes, reduced sharpness of vision (visual acuity), blurred vision, rainbows or halos around objects, sensitivity to light (photophobia), dry eyes. As with any new product, problems may occur which are currently unforeseeable.
Where is the study run from?
The study will be carried out in five sites in the UK.
When is study starting and how long is it expected to run for?
February 2012 to April 2013.
Who is funding the study?
Menicon Co., Ltd (Japan).
Who is the main contact?
Mr Hideto Ogawa
h-ogawa@menicon-net.co.jp
Contact information
Scientific
Menicon Co. Ltd
3-21-19
Aoi, Naka-ku
Nagoya
460-0006
Japan
Study information
| Study design | Three-month double-masked bilateral randomised comparative study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Three-month clinical evaluation of DP037, a multipurpose solution for Rigid Gas Permeable (RGP) lenses |
| Study objectives | The DP037 RGP multipurpose solution is substantially equivalent to the another RGP solution when used with a rub and rinse regimen. |
| Ethics approval(s) | 1. UK: NRES committee South East Coast - Brighton and Sussex, 27/07/2012, ref: 12/LO/1035 2. UK: MHRA, 09/08/2012, ref: CI/2012/0027. Amendments approved on 23/08/2012. |
| Health condition(s) or problem(s) studied | Contact lens wear |
| Intervention | Subjects will be randomly assigned to use either the test or the control solution and clinically evaluated at the initial baseline visit (Visit 1), then after 1 week, 1 month, and 3 months of lens wear. |
| Intervention type | Other |
| Primary outcome measure | 1. Comfort 2. Comfortable wearing time 3. Lens surface 4. Slit lamp findings for 3 months |
| Secondary outcome measures | No secondary outcome measures |
| Overall study start date | 18/02/2012 |
| Completion date | 09/04/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Approximately 60 subjects (approximately 40 subjects will be assigned to use the test solution and 20 subjects to use the control solution). |
| Key inclusion criteria | 1. Be a currently adapted RGP contact lens wearer (>3 months of lens wear) 2. Wearing their habitual RGP contact lenses to baseline visit 3. Be at least 18 years of age 4. Have corneal astigmatism less than or equal to 3.00D 5. Have clear corneas and be free of any anterior segment disorders 6. Be correctable through spherocylindrical refraction to 6/12 (20/40) or better in each eye 7. Spherical spectacle prescriptions between +6.00D and -10.00D (inclusive) 8. Require visual correction in both eyes (monovision allowed, but not monofit) 9. Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having: 9.1. No amblyopia 9.2. No strabismus 9.3. No evidence of lid abnormality or infection 9.4. No conjunctival abnormality or infection that would contraindicate contact lens wear 9.5. No clinically significant slit lamp findings (i.e. corneal staining, stromal oedema, staining, scarring, vascularisation, infiltrates or abnormal opacities) 9.6. No other active ocular disease |
| Key exclusion criteria | 1. Under 18 years of age 2. Wear toric or multifocal RGP designs 3. Previously shown a sensitivity to any of the study solutions components 4. Any systemic or ocular disease or allergies affecting ocular health 5. Using systemic or topical medications that will in the investigator's opinion affect ocular physiology or lens performance 6. Clinically significant (no less than Grade 3) corneal staining, corneal stromal oedema, corneal vascularisation, tarsal abnormalities, bulbar hyperaemia, limbal hyperaemia, or any other abnormality of the cornea that would contraindicate contact lens wear 7. Any corneal infiltrates or any corneal scarring or neovascularisation within the central 5mm of the cornea 8. Keratoconus or other corneal irregularity 9. Aphakia or amblyopia 10. Subjects who have undergone corneal refractive surgery or any anterior segment surgery 11. Abnormal lacrimal secretions 12. Has diabetes 13. Known/reported infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease [e.g. Human immunodeficiency virus (HIV)] 14. History of chronic eye disease [e.g. glaucoma or Age-related macular degeneration (ARMD)] 15. Pregnant or lactating or planning a pregnancy at the time of enrolment 16. Participation in any concurrent clinical trial or in last 30 days |
| Date of first enrolment | 25/08/2012 |
| Date of final enrolment | 27/11/2012 |
Locations
Countries of recruitment
- Japan
- United Kingdom
Study participating centre
460-0006
Japan
Sponsor information
Industry
3-21-19
Aoi, Naka-ku
Nagoya
460-0006
Japan
| Website | http://www.menicon.com/ |
|---|---|
"ROR" |
https://ror.org/032a2g603 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | There are no specific plans for publication or dissemination of the study results. |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date. |
Editorial Notes
12/01/2018: The overall trial dates have been updated from 01/08/2012-31/12/2012 to 18/02/2012-09/04/2013. The recruitment dates have been updated from 01/08/2012-31/12/2012 to 25/08/2012-27/11/2012. The publication and dissemination plans have been updated. The participant level data sharing statement has been added.
07/12/2017: No publications found in PubMed, verifying study status with principal investigator.
