A Lifestyle Investigation With Spectacles and Daily Disposable Contact Lenses in Young Patients

• Sponsor: CIBA VISION (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01445652
• Collaborator: University of Manchester (Other)
• Enrollment: 113
• Location: 1
• Arms: 2
• Duration (Months): 9
• Patients Per Site Per Month: 12.6

Study Details

Study Description

Brief Summary

The purpose of this study was to evaluate the relative benefits of daily disposable contact lenses versus spectacles in young adults.

Condition or Disease	Intervention/Treatment	Phase
Myopia	Device: nelfilcon A contact lens; Other: Spectacles	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 113 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Lifestyle Investigation With Spectacles and Daily Disposable Contact Lenses in Young Patients
• Study Start Date: Sep 1, 2011
• Actual Primary Completion Date: Jun 1, 2012
• Actual Study Completion Date: Jun 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: nelfilcon A Nelfilcon A contact lenses worn in both eyes on a daily disposable basis a minimum of five days per week, eight hours per day, for six months	Device: nelfilcon A contact lens; Commercially marketed, single vision, soft contact lens for daily disposable wear; Other Names: DAILIES AQUACOMFORT PLUS
Active Comparator: Spectacles Spectacles per current prescription worn a minimum of five days per week, eight hours per day, for six months	Other: Spectacles; Spectacles per current prescription

Outcome Measures

Primary Outcome Measures

1. Subjective Happiness With Correction Type [Month 6]

   Participant responded to an SMS message: "Please rate your happiness (H) and vision (V) with your [contact lenses/spectacles]: 1=very poor; 2=poor; 3=neither; 4=good; and 5=very good. eg H2V4. Please send N if in you are not wearing [contact lenses/spectacles]."

2. Subjective Vision With Correction Type [Month 6]

   Participant responded to an SMS message: "Please rate your happiness (H) and vision (V) with your [contact lenses/spectacles]: 1=very poor; 2=poor; 3=neither; 4=good; and 5=very good. eg H2V4. Please send N if in you are not wearing [contact lenses/spectacles]."

Eligibility Criteria

Criteria

• Ages Eligible for Study: 13 Years to 19 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Understands rights as a research subject and willing and able to sign a Statement of Informed Consent, or if under 18, parent or guardian understands rights and is willing and able to sign a Statement of Informed Consent.

• Willing and able to follow the protocol.

• Currently wearing spectacles full-time (at least five days per week, eight hours per day).

• Has never worn contact lenses (more than one day) before.

• Agrees to not participate in other clinical research for the duration of this study.

• Can attain at least 6/9 in each eye with the study optical correction.

• Can be fitted with study lenses in the available power range (contact lens group) or can select a satisfactory spectacle lens frame and lenses (spectacle group).

• Willing and able to wear the study lenses or spectacles for a minimum of five days per week, eight hours per day.

• Owns or has regular access to a mobile phone and is familiar with SMS text messaging.

• Has an up-to-date and functional pair of spectacles at time of enrollment.

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Has an ocular or systemic disorder that would normally contraindicate contact lens wear.

• Is using any topical medication such as eye drops or ointment.

• Has had corneal refractive surgery.

• Has had cataract surgery.

• Has diabetes.

• Has taken part in other clinical research within two weeks of starting the study.

• Other protocol-defined exclusion criteria may apply.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Eurolens Research	Manchester		United Kingdom	M13 9PT

Sponsors and Collaborators

• CIBA VISION
• University of Manchester

Investigators

• Principal Investigator: Philip Morgan, PhD MCOptom FAAO FBCLA, University of Manchester

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: CIBA VISION
• ClinicalTrials.gov Identifier: NCT01445652
• Other Study ID Numbers: P-370-C-091 / CB11-500
• First Posted: Oct 4, 2011
• Last Update Posted: Sep 19, 2013
• Last Verified: Sep 1, 2013

• Additional relevant MeSH terms: Myopia

Study Results

Participant Flow

Recruitment Details	Participants were enrolled from one study center in the United Kingdom.
Pre-assignment Detail	Of the 113 participants enrolled, 3 were exited as screen failures prior to randomization. This reporting group includes all enrolled and randomized participants (110).

Arm/Group Title	Nelfilcon A	Spectacles
Arm/Group Description	Nelfilcon A contact lenses worn in both eyes on a daily disposable basis a minimum of five days per week, eight hours per day, for six months	Spectacles per current prescription worn a minimum of five days per week, eight hours per day, for six months
Period Title: Overall Study
STARTED	57	53
COMPLETED	47	50
NOT COMPLETED	10	3

Baseline Characteristics

Arm/Group Title	Nelfilcon A	Spectacles	Total
Arm/Group Description	Nelfilcon A contact lenses worn in both eyes on a daily disposable basis a minimum of five days per week, eight hours per day, for six months	Spectacles per current prescription worn a minimum of five days per week, eight hours per day, for six months	Total of all reporting groups
Overall Participants	57	53	110
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	16.2 (1.8)	16.3 (2.0)	16.2 (1.9)
Sex: Female, Male (Count of Participants)
Female	32 56.1%	31 58.5%	63 57.3%
Male	25 43.9%	22 41.5%	47 42.7%
Region of Enrollment (participants) [Number]
United Kingdom	57 100%	53 100%	110 100%

Outcome Measures

1. Primary Outcome

Title	Subjective Happiness With Correction Type
Description	Participant responded to an SMS message: "Please rate your happiness (H) and vision (V) with your [contact lenses/spectacles]: 1=very poor; 2=poor; 3=neither; 4=good; and 5=very good. eg H2V4. Please send N if in you are not wearing [contact lenses/spectacles]."
Time Frame	Month 6

Outcome Measure Data

Analysis Population Description

This reporting group includes all participants who sent in an SMS response.

Arm/Group Title	Nelfilcon A	Spectacles
Arm/Group Description	Nelfilcon A contact lenses worn in both eyes on a daily disposable basis a minimum of five days per week, eight hours per day, for six months	Spectacles per current prescription worn a minimum of five days per week, eight hours per day, for six months
Measure Participants	14	21
Mean (Standard Deviation) [Units on a Scale]	4.92 (0.3)	4.50 (0.9)

2. Primary Outcome

Title	Subjective Vision With Correction Type
Description	Participant responded to an SMS message: "Please rate your happiness (H) and vision (V) with your [contact lenses/spectacles]: 1=very poor; 2=poor; 3=neither; 4=good; and 5=very good. eg H2V4. Please send N if in you are not wearing [contact lenses/spectacles]."
Time Frame	Month 6

Outcome Measure Data

Analysis Population Description

This reporting group includes all participants who sent in an SMS response.

Arm/Group Title	Nelfilcon A	Spectacles
Arm/Group Description	Nelfilcon A contact lenses worn in both eyes on a daily disposable basis a minimum of five days per week, eight hours per day, for six months	Spectacles per current prescription worn a minimum of five days per week, eight hours per day, for six months
Measure Participants	14	21
Mean (Standard Deviation) [Units on a scale]	4.5 (0.7)	4.5 (0.8)

Adverse Events

Time Frame	Adverse events were collected for the duration of the study (9 months). An adverse event was defined as any unfavourable or unintended sign or symptom associated with the use of a contact lens, but not necessarily caused by the contact lens.
Adverse Event Reporting Description	This reporting group includes all enrolled and randomized participants.
Arm/Group Title	Nelfilcon A		Spectacles
Arm/Group Description	Nelfilcon A contact lenses worn in both eyes on a daily disposable basis a minimum of five days per week, eight hours per day, for six months		Spectacles per current prescription worn a minimum of five days per week, eight hours per day, for six months
All Cause Mortality
	Nelfilcon A		Spectacles
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Nelfilcon A		Spectacles
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/57 (0%)		0/53 (0%)
Other (Not Including Serious) Adverse Events
	Nelfilcon A		Spectacles
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/57 (7%)		0/53 (0%)
Eye disorders
Corneal inflammatory event	4/57 (7%)		0/53 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

Sponsor reserves the right of prior review of any publication or presentation of information related to the study.