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

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

Study Overview

• Status: Completed
• Conditions: Refractive Error; Myopia
• Intervention / Treatment: Device: spectacles; Device: narafilcon A soft contact lenses

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Greater Manchester
    • Manchester, Greater Manchester, United Kingdom, M60 1QD
      • Eurolens Research, The University of Manchester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 39 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. They are of legal age (18 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: spectacles; habitual spectacles worn daily for 12 months	Device: spectacles; habitual spectacles
Experimental: narafilcon A soft contact lenses; narafilcon A soft contact lenses worn as daily disposable for 12 months	Device: narafilcon A soft contact lenses; narafilcon A daily disposable contact lenses

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biomicroscopy Findings After 12 Months of Daily Wear From Slit Lamp Analysis.	Comprised of 8 categories (conjunctival hyperemia, limbal hyperemia, corneal vascularization, microcysts, Oedema, corneal staining, conjunctival staining and papillary conjunctivitis) each scored on a scale of 0 to 4 where 0=none, and 4=maximum score for each category.	at 12 months
Visual Acuity After 12 Months of Wear	Visual acuity is measured at high and low contrasts, via the Snellen scale which is then mathematically converted to logMar units. High contrast refers to a darker print on the Snellen chart and is an easier testing environment compared to the low contrast which has a grayer print.	at 12 months
Subjective Overall Comfort After 12 Months of Daily Wear	subject response using a scale of 0 to 100, where 0 = poor comfort, 100 = excellent comfort	at 12 months
Subjective Overall Vision After 12 Months of Daily Wear	subject response using a scale of 0 to 100, where 0 = poor vision, 100 = excellent vision	at 12 months

Collaborators and Investigators

• Sponsor: Johnson & Johnson Vision Care, Inc.
• Collaborators: University of Manchester

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2008
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: June 27, 2008
• First Submitted That Met QC Criteria: June 27, 2008
• First Posted (Estimate): July 2, 2008

Study Record Updates

• Last Update Posted (Actual): December 10, 2019
• Last Update Submitted That Met QC Criteria: December 3, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors
• Other Study ID Numbers: CR-0806