Clinical Evaluation of DP037, for contact lens users

Not Applicable

Completed

• Conditions: Contact lens wear; Eye Diseases

• Registration Number: ISRCTN28788224
• Lead Sponsor: Menicon Co. Ltd (Japan)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-07-13
• Study Completion: 2013-04-09
• Last Update Posted: 12 February 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

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; 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

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; 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified