Clinical Comparison of Two Silicone Hydrogel Toric Lenses in the US

• Sponsor: CIBA VISION (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01007812
• Collaborator: (none)
• Enrollment: 50
• Arms: 2
• Duration (Months): 1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Astigmatism	Device: Lotrafilcon B contact lens; Device: Comfilcon A contact lens	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Clinical Comparison of Two Silicone Hydrogel Toric Lenses in the US
• Study Start Date: Oct 1, 2009
• Actual Primary Completion Date: Nov 1, 2009
• Actual Study Completion Date: Nov 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Other: Lotrafilcon B / Comfilcon A Lotrafilcon B silicone hydrogel, toric, soft contact lenses worn for one week, followed by Comfilcon A silicone hydrogel, toric, soft contact lenses worn for one week.	Device: Lotrafilcon B contact lens; Silicone hydrogel, toric, soft contact lens; Device: Comfilcon A contact lens; Silicone hydrogel, toric, soft contact lens
Other: Comfilcon A / Lotrafilcon B Comfilcon A silicone hydrogel, toric, soft contact lenses worn for one week, followed by Lotrafilcon B silicone hydrogel, toric, soft contact lenses worn for one week.	Device: Lotrafilcon B contact lens; Silicone hydrogel, toric, soft contact lens; Device: Comfilcon A contact lens; Silicone hydrogel, toric, soft contact lens

Outcome Measures

Primary Outcome Measures

1. Overall Vision [After 1 week of wear]

   Overall vision, as interpreted by the subject and reported by the subject on a questionnaire as a single, retrospective evaluation of one week's wear time. Overall vision was measured 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:

• Have a current spectacle prescription, preferably within 6-9 months.

• Currently wearing toric soft contact lenses in both eyes with at least 1 month experience wearing current brand for daily wear.

• Be correctable to at least 20/40 distance visual acuity in each eye while wearing trial lenses in the parameters available for this trial.

• Have acceptable or optimal fit for each eye at the dispense of each pair of study lenses.

• Other protocol-defined inclusion/exclusion criteria may apply.

Exclusion Criteria:

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

• Currently enrolled in any Clinical Trial.

• Evidence of systemic or ocular abnormality, infection or disease which is likely to affect successful wear of contact lenses or use of their accessory solutions as determined by the investigator.

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

• Currently wearing soft toric contact lenses as extended wear.

• Currently wearing either of the products to be worn in the study.

• Other protocol-defined 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: NCT01007812
• Other Study ID Numbers: P-242-C-032
• First Posted: Nov 4, 2009
• Last Update Posted: Jun 29, 2012
• Last Verified: Jan 1, 2012

• Additional relevant MeSH terms: Astigmatism

Study Results

Participant Flow

Arm/Group Title	Lotrafilcon B / Comfilcon A	Comfilcon A / Lotrafilcon B
Arm/Group Description	Lotrafilcon B silicone hydrogel, toric, soft contact lenses worn for one week, followed by Comfilcon A silicone hydrogel, toric, soft contact lenses worn for one week. Both products worn in a daily wear modality.	Comfilcon A silicone hydrogel, toric, soft contact lenses worn for one week, followed by Lotrafilcon B silicone hydrogel, toric, soft contact lenses worn for one week. Both products worn in a daily wear modality.
Period Title: Period 1, One Week
STARTED	25	25
COMPLETED	24	24
NOT COMPLETED	1	1
Period Title: Period 1, One Week
STARTED	24	24
COMPLETED	24	24
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Overall Study
Arm/Group Description	This reporting group includes all enrolled and dispensed subjects.
Overall Participants	50
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	33.4 (11.2)
Sex: Female, Male (Count of Participants)
Female	33 66%
Male	17 34%

Outcome Measures

1. Primary Outcome

Title	Overall Vision
Description	Overall vision, as interpreted by the subject and reported by the subject on a questionnaire as a single, retrospective evaluation of one week's wear time. Overall vision was measured on a 10-point scale, with 1 being poor and 10 being excellent.
Time Frame	After 1 week of wear

Outcome Measure Data

Analysis Population Description

Per Protocol

Arm/Group Title	Lotrafilcon B Contact Lens	Comfilcon A Contact Lens
Arm/Group Description	Silicone hydrogel, toric, soft contact lens	Silicone hydrogel, toric, soft contact lens
Measure Participants	48	48
Mean (Standard Deviation) [Units on a Scale]	8.2 (1.8)	8.3 (1.8)

Adverse Events

Time Frame	Adverse events were collected for the duration of the study: 29 days.
Adverse Event Reporting Description	In this cross-over study, each participant wore the first product per the randomization, but not the second, due to discontinuation from the study.
Arm/Group Title	Lotrafilcon B Contact Lens		Comfilcon A Contact Lens
Arm/Group Description	Silicone hydrogel, toric, soft contact lens		Silicone hydrogel, toric, soft contact lens
All Cause Mortality
	Lotrafilcon B Contact Lens		Comfilcon A Contact Lens
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Lotrafilcon B Contact Lens		Comfilcon A Contact Lens
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/49 (0%)		0/49 (0%)
Other (Not Including Serious) Adverse Events
	Lotrafilcon B Contact Lens		Comfilcon A Contact Lens
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/49 (0%)		0/49 (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.