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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00708032

Enrollment

Registered

2008-07-02

Start date

2008-06-01

Completion date

2009-12-01

Last updated

2019-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myopia, Refractive Error

Brief summary

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

Interventions

DEVICEspectacles

habitual spectacles

DEVICEnarafilcon A soft contact lenses

narafilcon A daily disposable contact lenses

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 39 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

United Kingdom

Participant flow

Recruitment details

There were 74 subjects enrolled into the study, 38 into the TruEye group and 36 in the spectacle group. Forty-eight subjects completed the study.

Participants by arm

Arm	Count
Spectacles spectacles worn daily for 12 months	36
Narafilcon A Lenses narafilcon A soft contact lenses worn as daily disposable for 12 months	38
Total	74

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Adverse Event	0	2
Overall Study	Did not meet protocol criteria	1	2
Overall Study	Lost to Follow-up	1	2
Overall Study	Poor vision	0	6
Overall Study	Pregnancy	0	1
Overall Study	Protocol Violation	4	1
Overall Study	Visit out of range at month 12	4	1
Overall Study	Withdrawal by Subject	0	1

Baseline characteristics

Characteristic	Spectacles	Narafilcon A Lenses	Total
Age, Continuous	26.5 years STANDARD_DEVIATION 8.1	26.5 years STANDARD_DEVIATION 7.4	26.5 years STANDARD_DEVIATION 7.7
Region of Enrollment United Kingdom	36 Participants	38 Participants	74 Participants
Sex: Female, Male Female	16 Participants	19 Participants	35 Participants
Sex: Female, Male Male	20 Participants	19 Participants	39 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 36	0 / 38
other Total, other adverse events	5 / 36	4 / 38
serious Total, serious adverse events	0 / 36	0 / 38

Outcome results

Primary

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.

Time frame: 12 months