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

• ClinicalTrials.gov Identifier: NCT00708643
• Recruitment Status: Completed
• First Posted: July 2, 2008
• Results First Posted: December 1, 2010
• Last Update Posted: May 21, 2015
• Sponsor: Johnson & Johnson Vision Care, Inc.
• Collaborator: University of Manchester
• Information provided by (Responsible Party): Johnson & Johnson Vision Care, Inc.

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Refractive Error; Myopia	Device: Habitual Silicone Hydrogel Contact Lens; Device: narafilcon A	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Study Start Date: June 2008
• Actual Primary Completion Date: September 2008
• Actual Study Completion Date: September 2008

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Habitual silicone hydrogel; Habitual contact lens wear.	Device: Habitual Silicone Hydrogel Contact Lens; contact lens
Experimental: narafilcon A; Silicone hydrogel daily disposable contact lens	Device: narafilcon A; contact lens

Outcome Measures

Primary Outcome Measures :

1. Limbal Hyperemia [ Time Frame: At 2 weeks and 4 weeks ]
   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.
2. Lens Comfort [ Time Frame: At 3,7,10,13,17,21,24, and 27 days ]

   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.

3. Upper Lid Margin Staining [ Time Frame: At 2 weeks and 4 weeks. ]
   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.

Secondary Outcome Measures :

1. Tarsal Roughness [ Time Frame: At 2 weeks and 4 weeks ]
   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.
2. Tarsal Hyperemia [ Time Frame: At 2 weeks and 4 weeks. ]
   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.
3. Corneal Staining [ Time Frame: At 2 weeks and 4 weeks. ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 17 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

Canada, Ontario

Centre for Contact Lens Research

Waterloo, Ontario, Canada, N2L 3G1

Sponsors and Collaborators

Johnson & Johnson Vision Care, Inc.

University of Manchester

More Information

• Responsible Party: Johnson & Johnson Vision Care, Inc.
• ClinicalTrials.gov Identifier: NCT00708643
• Other Study ID Numbers: CR-0803
• First Posted: July 2, 2008
• Results First Posted: December 1, 2010
• Last Update Posted: May 21, 2015
• Last Verified: May 2015

Additional relevant MeSH terms:

Refractive Errors; Eye Diseases