Evaluation of Daily Disposable Lenses With Multi-Purpose Solution (MPS)

Not Applicable

Completed

• Conditions: Myopia
• Interventions: Device: Nelfilcon A contact lens; Device: Etafilcon A contact lens; Device: FID 107027 solution

• Registration Number: NCT00733291
• Lead Sponsor: Alcon Research

Brief Summary

The purpose of this study is to evaluate daily disposable lenses inserted out of the blister package versus daily disposable lenses inserted after a pre-soak in Multi-purpose solution FID 107027.

Detailed Description

Corneal staining and subjective responses for ocular redness and comfort will be compared.

Study Timeline

• Study Start: 2008-01
• Primary Completion: 2008-02
• Study Completion: 2008-02
• Study First Submitted: 2008-08-11
• Study First Submitted QC: 2008-08-11
• Study First Posted: 2008-08-13
• Results First Submitted: 2009-04-10
• Results First Submitted QC: 2011-11-16
• Status Verified: 2011-12
• Results First Posted: 2011-12-21
• Last Update Submitted: 2011-12-21
• Last Update Posted: 2011-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• 18 years of age or older.
• Visual acuity correctable to 20/30 (Snellen) or better in each eye at distance with contact lenses.
• Successfully wearing hydrogel or silicone hydrogel contact lenses on a daily wear basis for at least two weeks prior to study.
• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria

• History of hypersensitivity to any components of the multi-purpose solution.
• Evidence or history of ocular conditions as prescribed in protocol.
• One functional eye or a monofit lens
• Any slit-lamp finding score equal to 1 at Visit 1 of each study period.
• Significant corneal staining at visit 1 of each study period as prescribed in protocol.
• Other protocol-defined exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Nelfilcon A soak / Nelfilcon A no-soak	Nelfilcon A contact lens	Nelfilcon A contact lenses inserted after being soaked overnight in a multi-purpose disinfecting solution, followed by nelfilcon A contact lenses inserted directly from the blister package. Each pair of lenses worn for 2 hours.
Nelfilcon A soak / Nelfilcon A no-soak	FID 107027 solution	Nelfilcon A contact lenses inserted after being soaked overnight in a multi-purpose disinfecting solution, followed by nelfilcon A contact lenses inserted directly from the blister package. Each pair of lenses worn for 2 hours.
Nelfilcon A no soak / nelfilcon A soak	Nelfilcon A contact lens	Nelfilcon A contact lenses inserted directly from the blister package, followed by nelfilcon A contact lenses inserted after being soaked overnight in a multi-purpose disinfecting solution. Each pair of lenses worn for 2 hours.
Nelfilcon A no soak / nelfilcon A soak	FID 107027 solution	Nelfilcon A contact lenses inserted directly from the blister package, followed by nelfilcon A contact lenses inserted after being soaked overnight in a multi-purpose disinfecting solution. Each pair of lenses worn for 2 hours.
Etafilcon A soak / etafilcon A no soak	Etafilcon A contact lens	Etafilcon A contact lenses inserted after being soaked overnight in a multi-purpose disinfecting solution, followed by etafilcon A contact lenses inserted directly from the blister package. Each pair of lenses worn for 2 hours.
Etafilcon A soak / etafilcon A no soak	FID 107027 solution	Etafilcon A contact lenses inserted after being soaked overnight in a multi-purpose disinfecting solution, followed by etafilcon A contact lenses inserted directly from the blister package. Each pair of lenses worn for 2 hours.
Etafilcon A no soak / etafilcon A soak	Etafilcon A contact lens	Etafilcon A contact lenses inserted directly from the blister package, followed by etafilcon A contact lenses inserted after being soaked overnight in a multi-purpose disinfecting solution. Each pair of lenses worn for 2 hours.
Etafilcon A no soak / etafilcon A soak	FID 107027 solution	Etafilcon A contact lenses inserted directly from the blister package, followed by etafilcon A contact lenses inserted after being soaked overnight in a multi-purpose disinfecting solution. Each pair of lenses worn for 2 hours.

Primary Outcome Measures

Name	Time	Method
Average Corneal Staining Area	After 2 hours of wear	Percentage corneal staining was assessed by the investigator for each of five regions of the cornea, i.e., four quadrants plus central. The investigator instilled fluorescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and a yellow filter. Percentage corneal staining area was recorded in increments of ten, and the percentages of the five regions were averaged together.
Total Corneal Staining Type	After 2 hours of wear	Total corneal staining type was assessed by the investigator for each of 5 regions of the cornea, i.e., four quadrants plus central. The investigator instilled fluorescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and a yellow filter. Corneal staining type was recorded on a 5-point scale for each region: 0-none; 1-micropunctate; 2-macropunctate; 3-coalesced macropunctate; 4-patch (\>/= 1mm). The five regions were summed.

Secondary Outcome Measures

Name	Time	Method
Ocular Comfort	After 2 hours of wear	Ocular comfort was recorded by the participant on a questionnaire using a 5-point scale. Participant completed the sentence, "Right now my eyes feel..." with one of the following responses: 1-very comfortable; 2-comfortable; 3-neither comfortable nor uncomfortable; 4-uncomfortable; 5-very uncomfortable.
Ocular Redness	After two hours of wear	Ocular redness was recorded by the participant on a questionnaire using a 5-point scale. Participant completed the sentence, "Right now my eyes look..." with one of the following responses: 1-very white; 2-white; 3-neither white nor red; 4-red; 5-very red.

Trial Locations

Locations (1)

Contact Alcon Call Center for Trial Locations; 🇺🇸 Fort Worth, Texas, United States