Condition category
Eye Diseases
Date applied
04/07/2012
Date assigned
13/07/2012
Last edited
27/08/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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?
August to December 2012.

Who is funding the study?
Menicon Co., Ltd (Japan).

Who is the main contact?
Mr Hideto Ogawa
h-ogawa@menicon-net.co.jp

Trial website

Contact information

Type

Scientific

Primary contact

Mr Hideto Ogawa

ORCID ID

Contact details

Menicon Co. Ltd
3-21-19
Aoi
Naka-ku
Nagoya
460-0006
Japan

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

MENP-2901

Study information

Scientific title

Three-month clinical evaluation of DP037, a multipurpose solution for Rigid Gas Permeable (RGP) lenses

Acronym

Study hypothesis

The DP037 RGP multipurpose solution is substantially equivalent to the another RGP solution when used with a rub and rinse regimen.

Ethics approval

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.

Study design

Three-month double-masked bilateral randomised comparative study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

1. Comfort
2. Comfortable wearing time
3. Lens surface
4. Slit lamp findings for 3 months

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/08/2012

Overall trial end date

31/12/2012

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

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).

Participant 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

Recruitment start date

01/08/2012

Recruitment end date

31/12/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Menicon Co. Ltd
Nagoya
460-0006
Japan

Sponsor information

Organisation

Menicon Co. Ltd (Japan)

Sponsor details

3-21-19
Aoi
Naka-ku
Nagoya
460-0006
Japan

Sponsor type

Industry

Website

http://www.menicon.com/

Funders

Funder type

Industry

Funder name

Menicon Co. Ltd (Japan)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes