Clinical Comparison of Two Silicone Hydrogel Toric Lenses in the US

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Alcon Research ( CIBA VISION )

ClinicalTrials.gov Identifier:

NCT01007812

First received: November 2, 2009

Last updated: June 26, 2012

Last verified: January 2012

Purpose

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

Condition	Intervention
Astigmatism	Device: Lotrafilcon B contact lens Device: Comfilcon A contact lens

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	Clinical Comparison of Two Silicone Hydrogel Toric Lenses in the US

Resource links provided by NLM:

MedlinePlus related topics: Eye Wear

U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:

Overall Vision [ Time Frame: After 1 week of wear ] [ Designated as safety issue: No ]
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.

Enrollment:	50
Study Start Date:	October 2009
Study Completion Date:	November 2009
Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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
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

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier:	NCT01007812 History of Changes
Other Study ID Numbers:	P-242-C-032
Study First Received:	November 2, 2009
Results First Received:	September 29, 2010
Last Updated:	June 26, 2012
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Astigmatism
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on June 13, 2013