Prospective Study of Lens Performance of a Monthly Replacement Lens at Two Weeks and Four Weeks

Myopia Clinical Trial

Official title:

Prospective Study of Lens Performance of a Monthly Replacement Lens at Two Weeks and Four Weeks

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01293240
• Other study ID #: P-368-C-400
• Status: Completed
• Phase: N/A
• First received: February 9, 2011
• Last updated: June 26, 2012
• Start date: December 2010
• Est. completion date: April 2011

Study information

• Verified date: May 2012
• 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 compare the overall performance of a monthly replacement contact lens when worn for one month and when worn for two weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Habitual and successful wearers of contact lenses made of lotrafilcon B material for at least 4 weeks prior to enrollment.

• Good general health.

• Sphere requirement in the range +6.00 to -10.00 with astigmatism or multifocal correction or no astigmatism or multifocal correction.

• Ability to comply with all protocol-mandated procedures and to attend all scheduled office visits.

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Anterior segment abnormalities (i.e., cataracts, opacities, etc.) or active anterior segment disease.

• Administration of any investigational drug or device within 14 days of study initiation.

• Use of any eye drops with a pharmacological effect within 7 days of Visit 1.

• Known local or systemic hypersensitivity to contact lens cleaning and disinfecting solutions.

• Post-refractive surgery.

• Currently pregnant or lactating by case history.

• Other protocol-defined exclusion criteria may apply.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Astigmatism
• Myopia
• Presbyopia

Intervention

Device:
• lotrafilcon B contact lens
Commercially marketed, silicone hydrogel contact lens worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
CIBA VISION

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Comfort	Overall comfort was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 2 weeks of wear. Overall comfort was measured on a 10-point scale, with 1 being poor and 10 being excellent.	2 weeks	No
Primary	Overall Comfort	Overall comfort was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Overall comfort was measured on a 10-point scale, with 1 being poor and 10 being excellent.	4 weeks	No
Primary	End of Day Dryness	End of day dryness was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 2 weeks of wear. End of day dryness was measured on a 10-point scale, with 1 being very dry and 10 being not dry.	2 weeks	No
Primary	End of Day Dryness	End of day dryness was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. End of day dryness was measured on a 10-point scale, with 1 being very dry and 10 being not dry.	4 weeks	No
Primary	Ocular Redness	Ocular redness was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 2 weeks of wear. Ocular redness was measured on a 10-point scale, with 1 being very red and 10 being not red.	2 weeks	No
Primary	Ocular Redness	Ocular redness was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Ocular redness was measured on a 10-point scale, with 1 being very red and 10 being not red.	4 weeks	No
Primary	Visual Clarity	Visual clarity was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 2 weeks of wear. Visual clarity was measured on a 10-point scale, with 1 being poor and 10 being excellent.	2 weeks	No
Primary	Visual Clarity	Visual clarity was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Visual clarity was measured on a 10-point scale, with 1 being poor and 10 being excellent.	4 weeks	No
Primary	Lens Deposits	Protein and lipid deposits on the contact lens surface were assessed for each eye by the investigator using a biomicroscope, which magnifies the appearance of the contact lens on the wearer's eye. Deposits were graded on a scale of 0 to 4, with 0 being none and 4 being severe.	2 weeks	No
Primary	Lens Deposits	Protein and lipid deposits on the contact lens surface were assessed for each eye by the investigator using a biomicroscope, which magnifies the appearance of the contact lens on the wearer's eye. Deposits were graded on a scale of 0 to 4, with 0 being none and 4 being severe.	4 weeks	No
Primary	Corrected Visual Acuity	Each eye was tested individually while the participant read distant charts in normal lighting. Corrected visual acuity was measured using a Snellen chart, which was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equates to a logMAR acuity of 0.0 and is considered normal distance eyesight. Positive logMAR values indicate poorer vision, and negative values denote better visual acuity.	2 weeks	No
Primary	Corrected Visual Acuity	Each eye was tested individually while the participant read distant charts in normal lighting. Corrected visual acuity was measured using a Snellen chart, which was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equates to a logMAR acuity of 0.0 and is considered normal distance eyesight. Positive logMAR values indicate poorer vision, and negative values denote better visual acuity.	4 weeks	No