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

Myopia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00733291
• Other study ID #: MS-008
• Status: Completed
• Phase: N/A
• First received: August 11, 2008
• Last updated: December 21, 2011
• Start date: January 2008
• Est. completion date: February 2008

Study information

• Verified date: December 2011
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• Nelfilcon A contact lens
Commercially marketed, single vision, soft contact lens for daily disposable wear
• Etafilcon A contact lens
Commercially marketed, single vision, soft contact lens for daily disposable wear
• FID 107027 solution
Commercially marketed solution for contact lens disinfection

Locations

Country	Name	City	State
United States	Contact Alcon Call Center for Trial Locations	Fort Worth	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average Corneal Staining Area	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.	After 2 hours of wear	No
Primary	Total Corneal Staining Type	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.	After 2 hours of wear	No
Secondary	Ocular Comfort	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.	After 2 hours of wear	No
Secondary	Ocular Redness	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.	After two hours of wear	No