Comparative Clinical Evaluation of Daily Disposable Lenses in Symptomatic Lens Wearers

• Sponsor: CIBA VISION (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00953407
• Collaborator: (none)
• Enrollment: 128
• Arms: 5
• Duration (Months): 2

Study Details

Study Description

Brief Summary

The purpose of this trial is to evaluate the extent to which symptoms improve in symptomatic contact lens wearers when fit with one of 5 different daily disposable contact lenses.

Condition or Disease	Intervention/Treatment	Phase
Myopia	Device: Nelfilcon A contact lens; Device: Narafilcon A contact lens; Device: Etafilcon A contact lens; Device: Omafilcon A contact lens; Device: Hilafilcon B contact lens	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 128 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: Jul 1, 2009
• Actual Primary Completion Date: Sep 1, 2009
• Actual Study Completion Date: Sep 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Nelfilcon A Nelfilcon A contact lens	Device: Nelfilcon A contact lens; Daily disposable contact lens worn in a daily wear, daily disposable mode
Active Comparator: Narafilcon A Narafilcon A contact lens	Device: Narafilcon A contact lens; Daily disposable contact lens worn in a daily wear, daily disposable mode
Active Comparator: Etafilcon A Etafilcon A contact lens	Device: Etafilcon A contact lens; Daily disposable contact lens worn in a daily wear, daily disposable mode
Active Comparator: Omafilcon A Omafilcon A contact lens	Device: Omafilcon A contact lens; Daily disposable contact lens worn in a daily wear, daily disposable mode
Active Comparator: Hilafilcon B Hilafilcon B contact lens	Device: Hilafilcon B contact lens; Daily disposable contact lens worn in a daily wear, daily disposable mode

Outcome Measures

Primary Outcome Measures

1. Lens Awareness [4 weeks of wear]

   Lens awareness, as interpreted by the subject, was reported by the subject as a single, retrospective evaluation of 4 week's wear time. Frequency of lens awareness was measured on a 4-point scale, with 1 being never and 4 being all the time. Four-week ratings were compared to baseline ratings, and a negative difference (4-week minus baseline) represented an improvement.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Currently wear spherical, soft contact lenses replaced at intervals of 2 weeks or monthly.

• Habitually wear lenses for at least 8 hours per day, 4 days per week, for at least the past 6 months.

• Report 2 or more qualifying symptoms with current contact lenses with a frequency of "frequently" or "all the time"

• Able to achieve VA of at least 20/40 in each eye with habitual correction and with study lenses at dispense.

• Other protocol inclusion/exclusion criteria may apply.

Exclusion Criteria:

• Eye injury or surgery within twelve weeks immediately prior to enrollment.

• Currently enrolled in any clinical trial.

• Any use of medications for which contact lens wear could be contraindicated as determined by the investigator.

• History of corneal refractive surgery.

• Cylinder correction greater than 1.00 D.

• Current monovision contact lens wearers.

• Other protocol inclusion/exclusion criteria may apply.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• CIBA VISION

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: CIBA VISION
• ClinicalTrials.gov Identifier: NCT00953407
• Other Study ID Numbers: P-337-C-027
• First Posted: Aug 6, 2009
• Last Update Posted: Jul 10, 2012
• Last Verified: Jan 1, 2012

• Additional relevant MeSH terms: Myopia

Study Results

Participant Flow

Pre-assignment Detail	Two participants were enrolled but not dispensed due to failing inclusion/exclusion criteria. These participants were included in the Actual Enrollment calculation, but not Participant Flow or Baseline Characteristics calculations.

Arm/Group Title	Nelfilcon A	Narafilcon A	Etafilcon A	Omafilcon A	Hilafilcon B
Arm/Group Description	Nelfilcon A contact lens	Narafilcon A contact lens	Etafilcon A contact lens	Omafilcon A contact lens	Hilafilcon B contact lens
Period Title: Overall Study
STARTED	26	25	26	25	24
COMPLETED	25	24	25	23	23
NOT COMPLETED	1	1	1	2	1

Baseline Characteristics

Arm/Group Title	Nelfilcon A	Narafilcon A	Etafilcon A	Omafilcon A	Hilafilcon B	Total
Arm/Group Description	Nelfilcon A spherical contact lens worn on a daily wear, daily disposable basis	Narafilcon A spherical contact lens worn on a daily wear, daily disposable basis	Etafilcon A spherical contact lens worn on a daily wear, daily disposable basis	Omafilcon A spherical contact lens worn on a daily wear, daily disposable basis	Hilafilcon B spherical contact lens worn on a daily wear, daily disposable basis	Total of all reporting groups
Overall Participants	26	25	26	25	24	126
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	29.5 (7.0)	31.5 (11.9)	29.9 (10.1)	28.3 (7.7)	30.5 (9.6)	29.9 (9.3)
Sex: Female, Male (Count of Participants)
Female	18 69.2%	15 60%	20 76.9%	19 76%	17 70.8%	89 70.6%
Male	8 30.8%	10 40%	6 23.1%	6 24%	7 29.2%	37 29.4%

Outcome Measures

1. Primary Outcome

Title	Lens Awareness
Description	Lens awareness, as interpreted by the subject, was reported by the subject as a single, retrospective evaluation of 4 week's wear time. Frequency of lens awareness was measured on a 4-point scale, with 1 being never and 4 being all the time. Four-week ratings were compared to baseline ratings, and a negative difference (4-week minus baseline) represented an improvement.
Time Frame	4 weeks of wear

Outcome Measure Data

Analysis Population Description

Per protocol. Analysis excluded major protocol deviations as determined by masked review.

Arm/Group Title	Nelfilcon A	Narafilcon A	Etafilcon A	Omafilcon A	Hilafilcon B
Arm/Group Description	Nelfilcon A contact lens	Narafilcon A contact lens	Etafilcon A contact lens	Omafilcon A contact lens	Hilafilcon B contact lens
Measure Participants	25	24	24	23	23
Number [Participants]	16 (2.3) 61.5%	12 (2.8) 48%	11 (3.1) 42.3%	9 (2.5) 36%	13 (3.1) 54.2%

Adverse Events

Time Frame	8-1/2 weeks, duration of the study
Arm/Group Title	Nelfilcon A		Narafilcon A		Etafilcon A		Omafilcon A		Hilafilcon B
Arm/Group Description	Nelfilcon A contact lens		Narafilcon A contact lens		Etafilcon A contact lens		Omafilcon A contact lens		Hilafilcon B contact lens
All Cause Mortality
	Nelfilcon A		Narafilcon A		Etafilcon A		Omafilcon A		Hilafilcon B
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Nelfilcon A		Narafilcon A		Etafilcon A		Omafilcon A		Hilafilcon B
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/26 (0%)		0/25 (0%)		0/26 (0%)		0/25 (0%)		0/24 (0%)
Other (Not Including Serious) Adverse Events
	Nelfilcon A		Narafilcon A		Etafilcon A		Omafilcon A		Hilafilcon B
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/26 (0%)		0/25 (0%)		0/26 (0%)		0/25 (0%)		0/24 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

For a period of 10 years, the clinical investigator must hold all trial-related information and documents confidential and must agree to obtain sponsor's written consent before discussing, presenting, publicizing, or otherwise disclosing any preclinical and/or clinical data or impressions from this trial.