Clinical Performance of a New Daily Disposable Contact Lens Worn in a Neophyte Population.

NCT00708032 | Completed Results

• 1 other identifier: CR-0806
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

This study seeks to evaluate the impact of wearing a new daily disposable soft contact lens on the neophyte population.

Conditions

Refractive Error; Myopia

Outcome Measures

Primary Outcomes (1)

• Papillary Conjunctivitis

  Papillary conjunctivitis which is collected as part of the biomicroscopy data and is identified from a slit lamp examination. Grade 0 to Grade 4 with grade 0 implying no health concerns.

  12 months

Secondary Outcomes (4)

• Biomicroscopy Findings After 12 Months of Daily Wear From Slit Lamp Analysis.

  at 12 months

• Visual Acuity After 12 Months of Wear

  at 12 months

• Subjective Overall Comfort After 12 Months of Daily Wear

  at 12 months

• Subjective Overall Vision After 12 Months of Daily Wear

  at 12 months

Study Arms (2)

spectacles

OTHER

habitual spectacles worn daily for 12 months

Device: spectacles

narafilcon A soft contact lenses

EXPERIMENTAL

narafilcon A soft contact lenses worn as daily disposable for 12 months

Device: narafilcon A soft contact lenses

Interventions

spectacles DEVICE

habitual spectacles

spectacles

narafilcon A soft contact lenses DEVICE

narafilcon A daily disposable contact lenses

narafilcon A soft contact lenses

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• They are of legal age (18 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)

Eurolens Research, The University of Manchester

Manchester, Greater Manchester, M60 1QD, United Kingdom

Location

MeSH Terms

Conditions

Refractive Errors; Myopia

Interventions

Eyeglasses

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Lenses; Optical Devices; Equipment and Supplies

Results Point of Contact

• Title: Kathy Osborn, OD
• Organization: Johnson & Johnson Vision Care, Inc.

clinicalstudies@its.jnj.com

+1 904 443-1032

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• 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: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: December 10, 2019
• Results First Posted: December 8, 2011

Record last verified: 2019-11

Locations

GB (1)