Daily Disposable Toric Comparative Trial in Europe

Myopia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01070381
• Other study ID #: P-346-C-008
• Status: Completed
• Phase: N/A
• First received: February 16, 2010
• Last updated: November 19, 2013
• Start date: January 2010
• Est. completion date: March 2010

Study information

• Verified date: January 2012
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate the subjective and objective performance of two daily disposable lenses for wearers with astigmatism.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Current soft contact lens wearers able to be fit with soft toric lenses in the protocol-specified parameters.

• Achieve 0.5 or better distance visual acuity in each eye at time of dispense.

• Achieve acceptable or optimal fit in each eye at time of dispense.

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Habitual daily disposable contact lens wearer.

• Sleeps in contact lenses overnight.

• Currently enrolled in an ophthalmic clinical trial.

• Other protocol-defined exclusion criteria may apply.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Astigmatism
• Myopia

Intervention

Device:
• nelfilcon A contact lens
Commercially marketed, toric, soft contact lens for daily disposable wear
• ocufilcon D contact lens
Commercially marketed, toric, soft contact lens for daily disposable wear

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
CIBA VISION

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Comfort	Overall Comfort, as interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 1-week's wear time. Overall comfort is measured on a 10-point scale, with 1 being poor and 10 being excellent.	1 week of wear	No