Evaluation of Two Daily Disposable Contact Lenses for Wearers With Astigmatism

Myopia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01207466
• Other study ID #: P-415-C-001 sub 2
• Status: Completed
• Phase: N/A
• First received: September 21, 2010
• Last updated: June 27, 2012
• Start date: September 2010
• Est. completion date: October 2010

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 contact lenses for contact lens wearers with astigmatism.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Astigmatism
• Myopia

Intervention

Device:
• Nelfilcon A investigational contact lens
Investigational, soft contact lens for astigmatism worn on a daily disposable basis.
• Nelfilcon A commercial contact lens
Commercially marketed, soft contact lens for astigmatism worn on a daily disposable basis.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
CIBA VISION

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of Vision (Crisp and Clear)	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.	1 week of wear	No