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

Not Applicable

Completed

• Conditions: Refractive Error; Myopia
• Interventions: Device: spectacles; Device: narafilcon A soft contact lenses

• Registration Number: NCT00708032
• Lead Sponsor: Johnson & Johnson Vision Care, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06-01
• Study First Submitted: 2008-06-27
• Study First Submitted QC: 2008-06-27
• Study First Posted: 2008-07-02
• Primary Completion: 2009-12-01
• Study Completion: 2009-12-01
• Results First Submitted: 2011-11-03
• Results First Submitted QC: 2011-11-03
• Results First Posted: 2011-12-08
• Status Verified: 2019-11
• Last Update Submitted: 2019-12-03
• Last Update Posted: 2019-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
spectacles	spectacles	habitual spectacles worn daily for 12 months
narafilcon A soft contact lenses	narafilcon A soft contact lenses	narafilcon A soft contact lenses worn as daily disposable for 12 months

Primary Outcome Measures

Name	Time	Method
Papillary Conjunctivitis	12 months	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.

Secondary Outcome Measures

Name	Time	Method
Biomicroscopy Findings After 12 Months of Daily Wear From Slit Lamp Analysis.	at 12 months	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.
Visual Acuity After 12 Months of Wear	at 12 months	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.
Subjective Overall Comfort After 12 Months of Daily Wear	at 12 months	subject response using a scale of 0 to 100, where 0 = poor comfort, 100 = excellent comfort
Subjective Overall Vision After 12 Months of Daily Wear	at 12 months	subject response using a scale of 0 to 100, where 0 = poor vision, 100 = excellent vision

Trial Locations

Locations (1)

Eurolens Research, The University of Manchester; 🇬🇧 Manchester, Greater Manchester, United Kingdom