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

NCT00708643 | Completed Results

• 1 other identifier: CR-0803
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Refractive Error; Myopia

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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.

Secondary Outcomes (3)

• Tarsal Roughness

  At 2 weeks and 4 weeks

• Tarsal Hyperemia

  At 2 weeks and 4 weeks.

• Corneal Staining

  At 2 weeks and 4 weeks.

Study Arms (2)

Habitual silicone hydrogel

ACTIVE COMPARATOR

Habitual contact lens wear.

Device: Habitual Silicone Hydrogel Contact Lens

narafilcon A

EXPERIMENTAL

Silicone hydrogel daily disposable contact lens

Device: narafilcon A

Interventions

Habitual Silicone Hydrogel Contact Lens DEVICE

contact lens

Habitual silicone hydrogel

narafilcon A DEVICE

contact lens

narafilcon A

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• They are of legal age (17 years) and capacity to volunteer.
• They understand their rights as a research subject and are willing to sign a Statement of Informed Consent.
• They are willing and able to follow the protocol.
• They would be expected to attain at least 6/9 (20/30) in each eye with the study lenses.
• They are able to wear contact lenses with a back vertex power of -1.00 to -6.00DS.
• They have a maximum of 1.00D of refractive astigmatism (i.e. ≤ 1.00 DC).
• They have successfully worn contact lenses within six months of starting the study.

You may not qualify if:

• They have an ocular disorder which would normally contra-indicate contact lens wear.
• They have a systemic disorder which would normally contra-indicate contact lens wear.
• They are using any topical medication such as eye drops or ointment.
• They are aphakic.
• They have had corneal refractive surgery.
• They have any corneal distortion resulting from previous hard or rigid lens wear or has keratoconus.
• They are pregnant or lactating.
• 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.
• They have any infectious disease (e.g. hepatitis) or any immunosuppressive disease (e.g. HIV).
• They have diabetes.
• They have taken part in any other clinical trial or research, within two weeks prior to starting this study.

Sponsors & Collaborators

• Johnson & Johnson Vision Care, Inc.: lead
• University of Manchester: collaborator

Study Sites (1)

Centre for Contact Lens Research

Waterloo, Ontario, N2L 3G1, Canada

Location

MeSH Terms

Conditions

Refractive Errors; Myopia

Condition Hierarchy (Ancestors)

Eye Diseases

Results Point of Contact

• Title: Kurt Moody, O.D. FAOO
• Organization: Vistakon

904-443-3088

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2008
• First Posted: July 2, 2008
• Study Start: June 1, 2008
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: May 21, 2015
• Results First Posted: December 1, 2010

Record last verified: 2015-05

Locations

CA (1)