Clinical Performance of a New Daily Disposable Contact Lens Worn in an Established Contact Lens Wearing Population

Myopia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00708643
• Other study ID #: CR-0803
• Status: Completed
• Phase: N/A
• First received: June 27, 2008
• Last updated: May 5, 2015
• Start date: June 2008
• Est. completion date: September 2008

Study information

• Verified date: May 2015
• Source: Johnson & Johnson Vision Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

This study seeks to evaluate the clinical and subjective performance of a new daily disposable soft contact lens.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 17 Years and older

Eligibility

Inclusion Criteria:

1. They are of legal age (17 years) and capacity to volunteer.

2. They understand their rights as a research subject and are willing to sign a Statement of Informed Consent.

3. They are willing and able to follow the protocol.

4. They would be expected to attain at least 6/9 (20/30) in each eye with the study lenses.

5. They are able to wear contact lenses with a back vertex power of -1.00 to -6.00DS.

6. They have a maximum of 1.00D of refractive astigmatism (i.e. = 1.00 DC).

7. They have successfully worn contact lenses within six months of starting the study.

Exclusion Criteria:

1. They have an ocular disorder which would normally contra-indicate contact lens wear.

2. They have a systemic disorder which would normally contra-indicate contact lens wear.

3. They are using any topical medication such as eye drops or ointment.

4. They are aphakic.

5. They have had corneal refractive surgery.

6. They have any corneal distortion resulting from previous hard or rigid lens wear or has keratoconus.

7. They are pregnant or lactating.

8. They have grade 2 or greater of any of the following ocular surface signs: corneal oedema, corneal vascularisation, corneal staining, tarsal conjunctival changes or any other abnormality which would normally contraindicate contact lens wear.

9. They have any infectious disease (e.g. hepatitis) or any immunosuppressive disease (e.g. HIV).

10. They have diabetes.

11. They have taken part in any other clinical trial or research, within two weeks prior to starting this study.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Myopia
• Refractive Error
• Refractive Errors

Intervention

Device:
• Habitual Silicone Hydrogel Contact Lens
contact lens
• narafilcon A
contact lens

Locations

Country	Name	City	State
Canada	Centre for Contact Lens Research	Waterloo	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Johnson & Johnson Vision Care, Inc.	University of Manchester

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Limbal Hyperemia	Measures the redness of the limbal region of the eye on a scale of 0 to 100 grade with 0=none and 100=severe. The analysis is the average grade over all time frames.	At 2 weeks and 4 weeks	No
Primary	Lens Comfort	Rating of lens comfort by rating agreement to the following statement: "The lenses I am wearing are comfortable."; Rating using the following scale: 1=strongly agree, 2=agree, 3=neutral, 4=disagree, 5=strongly disagree. The rating is averaged over all time frames.	At 3,7,10,13,17,21,24, and 27 days	No
Primary	Upper Lid Margin Staining	Measures the trauma to tissue that lines the margin of the inside of the upper eyelid on a 0 to 3 scale, with 0=none to 3=severe. The analysis is the average grade over all time frames.	At 2 weeks and 4 weeks.	No
Secondary	Tarsal Roughness	Measures the amount of roughness to the tissue of the inside upper and lower eyelid on a scale of 0 to 100 with 0=none and 100=severe. The analysis is the average grade over all time frames.	At 2 weeks and 4 weeks	No
Secondary	Tarsal Hyperemia	Measures the amount of redness to the tissue of the inside upper and lower eyelid using a 0 to 100 scale with 0=none and 100=severe.	At 2 weeks and 4 weeks.	No
Secondary	Corneal Staining	A measure of corneal abrasion using a 0 to 100 scale with 0=none, 25=micropunctate, 50=macropunctate, 75=coalescence, 100=patch. The analysis is the average grade over all time frames.	At 2 weeks and 4 weeks.	No