The Effect of Masking on Subjective Results During Daily Disposable Contact Lens Studies

Myopia Clinical Trial

— ARGON  

Official title:

The Effect of Masking on Subjective Results During Daily Disposable Contact Lens Studies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01155726
• Other study ID #: P-371-C-101
• Status: Completed
• Phase: N/A
• First received: June 30, 2010
• Last updated: June 26, 2012
• Start date: May 2010
• Est. completion date: February 2011

Study information

• Verified date: April 2012
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to explore the effect of masking on subjective ratings for two daily disposable contact lenses.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 17 Years and older

Eligibility

Inclusion Criteria:

• 17 years of age or older.

• Ocular exam within 2 years.

• Currently wearing soft contact lenses on a daily wear basis.

• Contact lens prescription between +6.00D and -10.00D.

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Any ocular disease.

• Use of systemic or ocular medications that may affect ocular health.

• Unable to achieve an acceptable fit with the study lenses.

• Anisometropia >1.00D or astigmatism >0.75D.

• Other protocol-defined exclusion criteria may apply.

Study Design

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

Related Conditions & MeSH terms

• Hyperopia
• Myopia

Intervention

Device:
• Nelfilcon A contact lens
Commercially marketed, soft, hydrogel contact lens for daily wear, daily disposable use. Blister pack label and lens packaging visible to participant. Lenses inserted and removed by participant.
• Nelfilcon A contact lens with comfort additive (DACP), unmasked
Commercially marketed, soft, hydrogel contact lens with comfort additive for daily wear, daily disposable use. Blister pack label and lens packaging visible to participant. Lenses and removed inserted by participant.
• Nelfilcon A contact lens with comfort additive (DACP), masked
Commercially marketed, soft, hydrogel contact lens for daily wear, daily disposable use. Blister pack label and packaging not visible to participant. Lenses inserted and removed by the investigator.
• Nelfilcon A contact lens with comfort additive (DACP), partially masked
Commercially marketed, soft, hydrogel contact lens for daily wear, daily disposable use. Lens name and manufacturer on blister pack label concealed from participant. Lenses inserted and removed by the participant.
• Etafilcon A contact lens
Commercially marketed, soft, hydrogel contact lens for daily wear, daily disposable use. Blister pack label and lens packaging visible to participant. Lenses inserted and removed by participant.
• Etafilcon A contact lens with comfort additive (1DAVM), unmasked
Commercially marketed, soft, hydrogel contact lens with comfort additive for daily wear, daily disposable use. Blister pack label and lens packaging visible to participant. Lenses inserted and removed by participant.
• Etafilcon A contact lens with comfort additive (1DAVM), masked
Commercially marketed, soft, hydrogel contact lens for daily wear, daily disposable use. Blister pack label and packaging not visible to participant. Lenses inserted and removed by the investigator.
• Etafilcon A contact lens with comfort additive (1DAVM), partially masked
Commercially marketed, soft, hydrogel contact lens for daily wear, daily disposable use. Lens name and manufacturer on blister pack label concealed from participant. Lenses inserted and removed by the participant.

Locations

Country	Name	City	State
Canada	Centre for Contact Lens Research: University of Waterloo	Waterloo	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
CIBA VISION

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average Subjective Comfort	Participants were asked, "How would you rate your comfort with your study lenses?" and indicated their response by marking a continuum line ranging from 0=very poor comfort to 100=excellent comfort. Subjective comfort was collected at three time points (insertion, 4 hours, 8 hours) for 3 days, and the comfort ratings were averaged together.	Insertion, 4 hours, 8 hours each: Day 1, Day 2, and Day 3	No