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

• Sponsor: Johnson & Johnson Vision Care, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00708032
• Collaborator: University of Manchester (Other)
• Enrollment: 74
• Location: 1
• Arms: 2
• Actual Duration (Months): 18
• Patients Per Site Per Month: 4.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Refractive Error; Myopia	Device: spectacles; Device: narafilcon A soft contact lenses	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 74 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Clinical Performance of a New Daily Disposable Contact Lens Worn in a Neophyte Population.
• Actual Study Start Date: Jun 1, 2008
• Actual Primary Completion Date: Dec 1, 2009
• Actual Study Completion Date: Dec 1, 2009

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

2. 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.

3. 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

4. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 39 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Eurolens Research, The University of Manchester	Manchester	Greater Manchester	United Kingdom	M60 1QD

Sponsors and Collaborators

• Johnson & Johnson Vision Care, Inc.
• University of Manchester

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Johnson & Johnson Vision Care, Inc.
• ClinicalTrials.gov Identifier: NCT00708032
• Other Study ID Numbers: CR-0806
• First Posted: Jul 2, 2008
• Last Update Posted: Dec 10, 2019
• Last Verified: Nov 1, 2019

• Additional relevant MeSH terms: Refractive Errors

Study Results

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.

Arm/Group Title	Spectacles	Narafilcon A Lenses
Arm/Group Description	spectacles worn daily for 12 months	narafilcon A soft contact lenses worn as daily disposable for 12 months
Period Title: Overall Study
STARTED	36	38
COMPLETED	26	22
NOT COMPLETED	10	16

Baseline Characteristics

Arm/Group Title	Spectacles	Narafilcon A Lenses	Total
Arm/Group Description	spectacles worn daily for 12 months	narafilcon A soft contact lenses worn as daily disposable for 12 months	Total of all reporting groups
Overall Participants	36	38	74
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	26.5 (8.1)	26.5 (7.4)	26.5 (7.7)
Sex: Female, Male (Count of Participants)
Female	16 44.4%	19 50%	35 47.3%
Male	20 55.6%	19 50%	39 52.7%
Region of Enrollment (Count of Participants)
United Kingdom	36 100%	38 100%	74 100%

Outcome Measures

1. Secondary Outcome

Title	Biomicroscopy Findings After 12 Months of Daily Wear From Slit Lamp Analysis.
Description	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.
Time Frame	at 12 months

Outcome Measure Data

Analysis Population Description

Subjects analyzed were those who were enrolled, randomized to a study arm, and completed the study.

Arm/Group Title	Narafilcon A Lenses	Spectacles
Arm/Group Description	narafilcon A soft contact lenses worn as daily disposable for 12 months	habitual spectacles worn daily for 12 months
Measure Participants	22	26
Conjunctival Hyperemia	1.09 (0.22)	1.00 (0.22)
Limbal Hyperemia	0.89 (0.25)	0.80 (0.24)
Corneal Vascularization	0.00 (0.00)	0.00 (0.00)
Microcysts	0.00 (0.00)	0.00 (0.00)
Oedema	0.00 (0.00)	0.00 (0.00)
Corneal Staining	0.33 (0.32)	0.25 (0.27)
Conjunctival Staining	0.83 (0.40)	0.22 (0.15)

2. Secondary Outcome

Title	Visual Acuity After 12 Months of Wear
Description	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.
Time Frame	at 12 months

Outcome Measure Data

Analysis Population Description

Subjects analyzed were those who were enrolled, randomized to a study arm, and completed the study.

Arm/Group Title	Narafilcon A Lenses	Spectacles
Arm/Group Description	narafilcon A soft contact lenses worn as daily disposable for 12 months	habitual spectacles worn daily for 12 months
Measure Participants	22	26
High Contrast	-0.05 (0.08)	-0.11 (0.06)
Low Contrast	0.29 (0.11)	0.18 (0.07)

3. Secondary Outcome

Title	Subjective Overall Comfort After 12 Months of Daily Wear
Description	subject response using a scale of 0 to 100, where 0 = poor comfort, 100 = excellent comfort
Time Frame	at 12 months

Outcome Measure Data

Analysis Population Description

Subjects analyzed were those who were enrolled, randomized to a study arm, and completed the study.

Arm/Group Title	Narafilcon A Lenses	Spectacles
Arm/Group Description	narafilcon A soft contact lenses worn as daily disposable for 12 months	habitual spectacles worn daily for 12 months
Measure Participants	22	26
Mean (Standard Deviation) [units on a scale]	87.8 (10.0)	82.2 (15.1)

4. Secondary Outcome

Title	Subjective Overall Vision After 12 Months of Daily Wear
Description	subject response using a scale of 0 to 100, where 0 = poor vision, 100 = excellent vision
Time Frame	at 12 months

Outcome Measure Data

Analysis Population Description

Subjects analyzed were those who were enrolled, randomized to a study arm, and completed the study.

Arm/Group Title	Narafilcon A Lenses	Spectacles
Arm/Group Description	narafilcon A soft contact lenses worn as daily disposable for 12 months	habitual spectacles worn daily for 12 months
Measure Participants	22	26
Mean (Standard Deviation) [units on a scale]	88.7 (11.5)	82.5 (15.1)

5. Primary Outcome

Title	Papillary Conjunctivitis
Description	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

Outcome Measure Data

Analysis Population Description

Subjects analyzed were those who were enrolled, randomized to a study arm, and completed the study.

Arm/Group Title	Narafilcon A Lenses	Spectacles
Arm/Group Description	narafilcon A soft contact lenses worn as daily disposable for 12 months	habitual spectacles worn daily for 12 months
Measure Participants	22	26
Mean (Standard Deviation) [units on a scale]	1.22 (0.21)	1.04 (0.26)

Adverse Events

Time Frame	Throughout the entire duration of the sutdy. Approximately 12 month.
Arm/Group Title	Spectacles		Narafilcon A Lenses
Arm/Group Description	spectacles worn daily for 12 months		narafilcon A soft contact lenses worn as daily disposable for 12 months
All Cause Mortality
	Spectacles		Narafilcon A Lenses
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/36 (0%)		0/38 (0%)
Serious Adverse Events
	Spectacles		Narafilcon A Lenses
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/36 (0%)		0/38 (0%)
Other (Not Including Serious) Adverse Events
	Spectacles		Narafilcon A Lenses
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/36 (13.9%)		4/38 (10.5%)
Eye disorders
Non-signficant Corneal Event	5/36 (13.9%)	27	4/38 (10.5%)	7

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Publication requires agreement and written consent from the Sponsor.