Clinical Comparison of Two Daily Disposable Toric Lenses

Myopia Clinical Trial

Official title:

Clinical Comparison of Two Daily Disposable Toric Lenses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01362894
• Other study ID #: P-346-C-013
• Status: Completed
• Phase: N/A
• First received: May 27, 2011
• Last updated: July 3, 2012
• Start date: May 2011
• Est. completion date: August 2011

Study information

• Verified date: July 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 trial was to compare the performance of two contact lenses commercially available for people with astigmatism.

Description:

This trial compared the performance of two commercialized daily disposable contact lenses in Germany.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Sign written informed consent.

• Germany: Be of legal age.

• Current monthly or weekly toric soft lens wearer able to be fit in both eyes with soft toric lenses in the study parameters.

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Eye injury or surgery within twelve weeks.

• Pre-existing ocular irritation that would preclude contact lens fitting.

• Currently enrolled in an ophthalmic clinical trial.

• Wears contact lenses overnight while sleeping.

• Habitual daily disposable contact lens wearer.

• Monovision correction during the study.

• 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, nelfilcon A, toric, soft contact lens for daily disposable wear.
• etafilcon A contact lens
Commercially marketed, etafilcon A, 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 Vision	As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall vision was rated on a 10-point scale, with 1 being poor and 10 being excellent.	1 week, replacing lenses daily	No
Primary	Overall Comfort	As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall comfort was rated on a 10-point scale, with 1 being poor and 10 being excellent.	1 week, replacing lenses daily	No
Primary	Overall Handling	As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall handling was rated on a 10-point scale, with 1 being difficult and 10 being easy.	1 week, replacing lenses daily	No
Primary	Overall Satisfaction	As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall vision was rated on a 10-point scale, with 1 being poor and 10 being excellent.	1 week, replacing lenses daily	No
Secondary	Ease of Selecting Final Lens Power	As interpreted by the investigator at time of lens fitting and recorded on a questionnaire. Ease of selecting final lens power was rated on a 10-point scale, with 1 being difficult and 10 being easy.	Day 0	No