A Study to Evaluate the Feasibility of a High Add Multi Focal Contact Lens

Presbyopia Clinical Trial

Official title:

A Study to Evaluate the Feasibility of a High Add Multi Focal Contact Lens

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01518868
• Other study ID #: 743E
• Status: Completed
• Phase: N/A
• Start date: January 2012
• Est. completion date: February 2012

Study information

• Verified date: September 2020
• Source: Bausch & Lomb Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to evaluate the product performance of the investigational multifocal high add soft contact lens compared with PureVision Multi-focal contact lens on a daily wear basis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Have physiologically normal anterior segments

• Be adapted wearers of soft contact lenses and wear a lens in each eye.

• Be presbyopic and require near add correction in each eye.

• Be an adapted monovision or multifocal contact lens wearer or be an adapted spherical lens wearer who also uses spectacles for near vision correction.

• Have no active ocular disease or allergic conjunctivitis.

• Must not be using any topical ocular medications.

• Must habitually use a lens care product for lens cleaning, disinfecting, and storage.

Exclusion Criteria:

• Any Grade 2 or greater finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.

• Any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.

• Anisometropia (spherical equivalent) of greater than 2.00 D.

• Any systemic disease affecting ocular health.

• Using any systemic or topical medications that will affect ocular physiology or lens performance.

• Allergic to any component in the study products.

• Ocular astigmatism of greater than 1.00 D in either eye.

• Have had any corneal surgery (ie, refractive surgery).

• Uses AMO Ultra Care as their habitual lens care regimen.

• Is a toric contact lens wearer.

• Have worn gas permeable (GP) contact lenses within last 30 days or PMMA lenses within last 3 months.

• An active ocular disease (for example but not limited to papillary conjunctivitis, any conjunctivitis: viral, bacterial, allergic), any corneal infiltrative response or are using any ocular medications.

Related Conditions & MeSH terms

• Presbyopia

Intervention

Device:
• Investigational contact lens
Worn on a daily wear basis for one week.
• PureVision contact lens
Worn on a daily wear basis for one week

Locations

Country	Name	City	State
United States	Bausch & Lomb, Incorporated	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
Bausch & Lomb Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Acuity	Visual acuity was assessed by distance high contrast logarithm of the minimum angle of resolution (logMAR).	At 2 weeks follow up
Secondary	Symptoms/Complaints	Symptoms/complaints were assessed on a scale from 0 to 100, with 0 denoting unfavorable symptoms/complaints.	At 2 weeks follow up