The Clinical and Subjective Performance of Three Different MPDS With Silicon Hydrogel Lenses

Adverse Reaction to Contact Lens Solution Clinical Trial

Official title:

The Evaluation of the Clinical and Subjective Performance of Three Different Contact Lens Care Solutions With Silicon Hydrogel Lenses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01665612
• Other study ID #: FI-2012
• Status: Completed
• Phase: N/A
• First received: August 8, 2012
• Last updated: March 5, 2015
• Start date: August 2012

Study information

• Verified date: March 2015
• Source: Finnsusp Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: National supervisory authority for wellfare and health
• Study type: Interventional

Clinical Trial Summary

The purpose of the clinical investigation is to assess the clinical and subjective performance of three novel multipurpose disinfecting solutions (MPDS) in daily wear with two silicone hydrogel contact lenses (Lotrafilcon B and Comfilcon A).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• age above 18

• experienced contact lens user

• good health (self-reported)

Exclusion Criteria:

• eye disease or eye operations

• pregnancy

• medication that can affect sight

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)

Related Conditions & MeSH terms

• Adverse Reaction to Contact Lens Solution

Intervention

Device:
• Contact lens care solution
Comparison of clinical and subjective performation of the contact lens care solutions used with two types of contact lenses

Locations

Country	Name	City	State
Finland	Raision Näkökulma	Raisio

Sponsors (1)

Lead Sponsor	Collaborator
Finnsusp Ltd.

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical performance	TBUT, conjunctival and limbal hyperemia, corneal vascularization, epithelial and stromal oedema, corneal infiltrates, endothelial regularity, corneal staining and papillar conjunctivitis	1 month	No
Secondary	Subjective performance	E.g. Comfort	1 month	No