A Comparison of Two Daily Disposable Contact Lenses

The Comparative Clinical Performance of Narafilcon A and the FOCUS DAILIES AquaComfort Plus Lens

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00634101

Enrollment

129

Registered

2008-03-12

Start date

2008-01-01

Completion date

2008-03-01

Last updated

2021-01-06

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

Conditions

Refractive Error, Myopia

Brief summary

This study seeks to evaluate the clinical performance of a new CE marked daily disposable contact lens that contains a wetting agent to a recently improved daily disposable contact lens.

Interventions

DEVICEnelfilcon A

contact lens

DEVICEnarafilcon A

contact lens

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 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
Dryness at the End of the Day	1-Week Follow-up	Dryness at the end of the day was assessed by the individual questionnaire item How dry did your eyes feel at the end of the day when wearing the contact lenses you were provided with the response cateogries 1=Extremely Dry, 2=Very Dry, 3=Moderately Dry, 4=Slightly Dry and 5=Not Dry at All. The number of participants that responsed in each cateogry was reported.
Comfort at the End of the Day	1-Week Follow-up	Comfort at the end of the day was assessed by the individual questionnaire item Comfort at the end of the day with the response cateogries 1=Poor, 2=Fair, 3=Good, 4=Very good and 5=Excellent. EOD Comfort was also assessed by the individual item How comfortable did your eyes feel at the end of the day when wearing the contact lenses you were provided? with the respopnse categories of 1=Extremely Uncomfortable, 2=Very Uncomfortable, 3=Slightly Uncomfortable, 4=Comfortable and 5= Very Comfortable. The number of participants that responsed in each cateogry for each item was reported.
Limbal Hyperaemia	1-Week Follow-up	Limbal Hyperaemia was measured using Efron Grading Scale ranges from 0 to 4 with 0.5 units increments (0 = Normal, 1 = Trace, 2 = Mild, 3 = Moderate, 4 = Severe).
Comfort Immediately When You First Put Them on	1-Week Follow-up	Comfort immediately when you first put them on was assessed by the individual questionnaire item Comfort immediately when you first put them on with the response cateogries 1=Poor, 2=Fair, 3=Good, 4=Very good and 5=Excellent. The number of participants that responsed in each cateogry was reported.
Comfort Throughout the Day	1-Week Follow-up	Comfort throughout the day was assessed by the individual questionnaire item Comfort throughout the day with the response cateogries 1=Poor, 2=Fair, 3=Good, 4=Very good and 5=Excellent. The number of participants that responsed in each cateogry was reported.
Lack of Dryness at the End of the Day	1-Week Follow-up	Lack of dryness at the end of the day was assessed by the individual questionnaire item Not making your eyes feel dry even at the end of the day with the response cateogries 1=Poor, 2=Fair, 3=Good, 4=Very good and 5=Excellent. The number of participants that responsed in each cateogry was reported.
Overall Opinion	1-Week Follow-up	Overall opinion was assessed by the individual questionnaire item Considering your experience with the contact lenses you were provided, which statement best describes your overall opinion of these contact lenses? with the response cateogries 1=Poor, 2=Fair, 3=Good, 4=Very good and 5=Excellent. The number of participants that responsed in each cateogry was reported.
Overall Comfort	1-Week Follow-up	Overall comfort was assessed by the individual questionnaire item Overall Comfort with the response cateogries 1=Poor, 2=Fair, 3=Good, 4=Very good and 5=Excellent. The number of participants that responsed in each cateogry was reported.
My Lenses Stayed Moist	1-Week Follow-up	My Lenses Stayed Moist was assessed by the individual questionnaire item They stayed moist and smooth, even after long hours at the computer with the response cateogries 1=Disagree Strongly, 2=Disagree Somewhat, 3=Neither Agree Nor Disagree, 4=Very Somewhat and 5=Agree Strongly. The number of participants that responsed in each cateogry was reported.
I Forgot i Was Wearing Lenses Was	1-Week Follow-up	I forgot i was wearing lenses was assessed by the individual questionnaire item They made me forget that I was wearing contact lenses with the response cateogries 1=Disagree Strongly, 2=Disagree Somewhat, 3=Neither Agree Nor Disagree, 4=Very Somewhat and 5=Agree Strongly. The number of participants that responsed in each cateogry was reported.
Mainted Natural Moisture	1-Week Follow-up	Mainted natural moisture was assessed by the individual questionnaire item They maintained my eyes' own natural moisture with the response cateogries 1=Disagree Strongly, 2=Disagree Somewhat, 3=Neither Agree Nor Disagree, 4=Very Somewhat and 5=Agree Strongly. The number of participants that responsed in each cateogry was reported.
Comfort While Wearing Lenses in Heat/Air Conditioned Environments	1-Week Follow-up	Comfort while wearing lenses in heat/air conditioned environments was assessed by the individual questionnaire item How often are you comfortable while sitting under or near an air conditioning vent or heating vent with the response cateogries 0=Not Applicable, 1=Always, 2=Frequently, 3=Occasionally, 4=Rarely and 5=never. The number of participants that responsed in each cateogry was reported.

Secondary

Measure	Time frame	Description
Overall Handling	1-Week Follow-up	Handling was assessed through opinion of handling in the final questionnaire. There were 5 categories Excellent (5), Very Good (4), Good (3), Fair (2) and Poor (1).

Countries

United Kingdom

Participant flow

Recruitment details

A total of 129 subject were enrolled into this study. Of those enrolled, all were assigned to a study lens, however, only 125 eligble to be dispensed. Of those dispensed, 117 subjects completed the study. However, this study was utlimately terminated.

Participants by arm

Arm	Count
Test (Narafilcon A) Subjects randomized to receive the Test lens throughout the study	67
Control (Nelfilcon A) Subjects randomized to receive the Control lens throughout the study	62
Total	129

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Lost to Follow-up	2	0
Overall Study	Study Terminated	3	3

Baseline characteristics

Characteristic	Test (Narafilcon A)	Control (Nelfilcon A)	Total
Age, Continuous	34.5 Years STANDARD_DEVIATION 10.4	33.9 Years STANDARD_DEVIATION 9.8	34.2 Years STANDARD_DEVIATION 10.1
Region of Enrollment United Kingdom	67 Participants	62 Participants	129 Participants
Sex: Female, Male Female	41 Participants	48 Participants	89 Participants
Sex: Female, Male Male	26 Participants	14 Participants	40 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 66	0 / 59
other Total, other adverse events	0 / 66	0 / 59
serious Total, serious adverse events	0 / 66	0 / 59

Outcome results

Primary

Comfort at the End of the Day

Comfort at the end of the day was assessed by the individual questionnaire item Comfort at the end of the day with the response cateogries 1=Poor, 2=Fair, 3=Good, 4=Very good and 5=Excellent. EOD Comfort was also assessed by the individual item How comfortable did your eyes feel at the end of the day when wearing the contact lenses you were provided? with the respopnse categories of 1=Extremely Uncomfortable, 2=Very Uncomfortable, 3=Slightly Uncomfortable, 4=Comfortable and 5= Very Comfortable. The number of participants that responsed in each cateogry for each item was reported.

Time frame: 1-Week Follow-up