Evaluation of Two Daily Disposable Contact Lenses for Wearers With Astigmatism

• Sponsor: CIBA VISION (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01207466
• Collaborator: (none)
• Enrollment: 95
• Arms: 2
• Duration (Days): 30

Study Details

Study Description

Brief Summary

The purpose of this trial is to compare the performance of two contact lenses for contact lens wearers with astigmatism.

Condition or Disease	Intervention/Treatment	Phase
Astigmatism; Myopia	Device: Nelfilcon A investigational contact lens; Device: Nelfilcon A commercial contact lens	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 95 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Study Start Date: Sep 1, 2010
• Actual Primary Completion Date: Oct 1, 2010
• Actual Study Completion Date: Oct 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Other: Nelfilcon A invest'l / nelfilconA comm'l Nelfilcon A investigational toric contact lenses worn first, with nelfilcon A commercial toric contact lenses worn second. Each product worn bilaterally on a daily disposable basis for one week.	Device: Nelfilcon A investigational contact lens; Investigational, soft contact lens for astigmatism worn on a daily disposable basis.; Device: Nelfilcon A commercial contact lens; Commercially marketed, soft contact lens for astigmatism worn on a daily disposable basis.; Other Names: Focus DAILIES Toric
Other: Nelfilcon A comm'l / nelfilconA invest'l Nelfilcon A commercial toric contact lenses worn first, with nelfilcon A investigational toric contact lenses worn second. Each product worn bilaterally on a daily disposable basis for one week.	Device: Nelfilcon A investigational contact lens; Investigational, soft contact lens for astigmatism worn on a daily disposable basis.; Device: Nelfilcon A commercial contact lens; Commercially marketed, soft contact lens for astigmatism worn on a daily disposable basis.; Other Names: Focus DAILIES Toric

Outcome Measures

Primary Outcome Measures

1. Quality of Vision (Crisp and Clear) [1 week of wear]

   Quality of vision (crisp and clear), as interpreted and reported by the participant by eye on a questionnaire as a single, retrospective evaluation of one week's wear time. Quality of vision was assessed on a 10-point scale, with 1 being poor and 10 being excellent.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Currently wearing soft contact lenses with astigmatism correction

• Other protocol inclusion criteria may apply

Exclusion Criteria:

• Eye injury or surgery within twelve weeks prior to enrollment

• Currently enrolled in an ophthalmic clinical trial

• Strabismus

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

• Other protocol 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: NCT01207466
• Other Study ID Numbers: P-415-C-001 sub 2
• First Posted: Sep 23, 2010
• Last Update Posted: Jul 10, 2012
• Last Verified: Jan 1, 2012

• Additional relevant MeSH terms: Astigmatism

Study Results

Participant Flow

Pre-assignment Detail	This reporting group includes all enrolled and dispensed participants. One participant was enrolled but not dispensed due to unacceptable fit. This participant is included in the Actual Enrollment calculation, but not Participant Flow or Baseline Characteristics calculations.

Arm/Group Title	Nelfilcon A Invest'l / nelfilconA Comm'l	Nelfilcon A Comm'l / nelfilconA Invest'l
Arm/Group Description	Nelfilcon A investigational toric contact lenses worn first, with nelfilcon A commercial toric contact lenses worn second. Each product worn bilaterally on a daily disposable basis for one week.	Nelfilcon A commercial toric contact lenses worn first, with nelfilcon A investigational toric contact lenses worn second. Each product worn bilaterally on a daily disposable basis for one week.
Period Title: Period 1, One Week of Wear
STARTED	46	48
COMPLETED	46	48
NOT COMPLETED	0	0
Period Title: Period 1, One Week of Wear
STARTED	45	48
COMPLETED	45	48
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Overall
Arm/Group Description	This reporting group includes all enrolled and dispensed subjects.
Overall Participants	94
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	35.8 (12.2)
Sex: Female, Male (Count of Participants)
Female	56 59.6%
Male	38 40.4%

Outcome Measures

1. Primary Outcome

Title	Quality of Vision (Crisp and Clear)
Description	Quality of vision (crisp and clear), as interpreted and reported by the participant by eye on a questionnaire as a single, retrospective evaluation of one week's wear time. Quality of vision was assessed on a 10-point scale, with 1 being poor and 10 being excellent.
Time Frame	1 week of wear

Outcome Measure Data

Analysis Population Description

Analysis conducted per protocol, with exclusions due to reasons such as: major protocol deviations as determined by masked review; discontinuations; and/or missing responses.

Arm/Group Title	Nelfilcon A Investigational	Nelfilcon A Commercial
Arm/Group Description	Investigational, soft contact lenses for astigmatism worn bilaterally on a daily disposable basis for one week.	Commercially marketed, soft contact lenses for astigmatism worn bilaterally on a daily disposable basis for one week.
Measure Participants	92	91
Measure eyes	184	182
Mean (Standard Deviation) [units on a scale]	8.8 (1.3)	8.6 (1.5)

Adverse Events

Time Frame	Adverse event data were collected for the duration of the trial: 45 days.
Adverse Event Reporting Description	This reporting group includes all enrolled and exposed participants.
Arm/Group Title	Nelfilcon A Investigational		Nelfilcon A Commercial
Arm/Group Description	Investigational, soft contact lenses for astigmatism worn bilaterally on a daily disposable basis for one week.		Commercially marketed, soft contact lenses for astigmatism worn bilaterally on a daily disposable basis for one week.
All Cause Mortality
	Nelfilcon A Investigational		Nelfilcon A Commercial
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Nelfilcon A Investigational		Nelfilcon A Commercial
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/95 (0%)		0/93 (0%)
Other (Not Including Serious) Adverse Events
	Nelfilcon A Investigational		Nelfilcon A Commercial
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/95 (0%)		0/93 (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.