Clinical Comparison of Two Daily Disposable Lenses Among Daily Disposable Lens Wearers

Myopia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01134211
• Other study ID #: P-337-C-033
• Status: Completed
• Phase: N/A
• First received: May 27, 2010
• Last updated: November 17, 2016
• Start date: May 2010
• Est. completion date: July 2010

Study information

• Verified date: October 2011
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

The primary objective of this trial is to evaluate the subjective performance of two different daily disposable contact lenses in a population of daily disposable lens wearers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 316
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Currently wearing any spherical daily disposable lens in daily wear, daily disposable modality for at least 3 months prior to enrollment with the exception of the 2 study products

• Currently Wearing lenses at least 8 hrs/day and 5 days/week.

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Eye injury or surgery within twelve weeks immediately prior to enrollment for this trial.

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

• 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.

• Prior history of corneal or refractive surgery.

• Requires monovision correction.

• Other protocol-defined exclusion criteria may apply.

Study Design

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

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• nelfilcon A
Commercially marketed, single-vision, soft contact lens for daily disposable wear
• filcon II 3
Commercially marketed, single-vision, soft contact lens for daily disposable wear

Locations

Country	Name	City	State
Germany	W.Hartwig - Qualität in jeder Hinsicht	Heikendorf

Sponsors (1)

Lead Sponsor	Collaborator
CIBA VISION

Country where clinical trial is conducted

Germany, 

References & Publications (1)

OVS, Marx et al. Subjective Performance of hydrogel and silicone hydrogel daily disposable contact lenses). AAO poster presentation 2014.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	subjective ratings and preferences		2 weeks	No