Clinical Comparison of Two Silicone Hydrogel Toric Lenses in the US

Astigmatism Clinical Trial

Official title:

Clinical Comparison of Two Silicone Hydrogel Toric Lenses in the US

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01007812
• Other study ID #: P-242-C-032
• Status: Completed
• Phase: N/A
• First received: November 2, 2009
• Last updated: June 26, 2012
• Start date: October 2009
• Est. completion date: November 2009

Study information

• Verified date: January 2012
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Astigmatism

Intervention

Device:
• Lotrafilcon B contact lens
Silicone hydrogel, toric, soft contact lens
• Comfilcon A contact lens
Silicone hydrogel, toric, soft contact lens

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
CIBA VISION

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Vision	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.	After 1 week of wear	No