A Study to Evaluate the Performance of Two Designs of Soft Toric Lenses

Myopia Clinical Trial

Official title:

A Study to Evaluate the Performance of Two Designs of Soft Toric Lenses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01309867
• Other study ID #: 680
• Status: Completed
• Phase: N/A
• Start date: December 2010
• Est. completion date: April 2011

Study information

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

Clinical Trial Summary

The objective of the study is to evaluate the product performance of the Bausch + Lomb toric investigational contact lenses compared to the currently marketed PureVision toric contact lenses.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 302
• Est. completion date: April 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects must have clear central corneas and be free of any anterior segment disorders.

• Subjects must be adapted lens wearers, wear a lens in each eye and each lens must be of the same manufacture and brand.

• Subjects must be myopic and require lens correction

• Subjects must be habitual wearers of toric soft contact lenses.

Exclusion Criteria:

• Subjects with any systemic disease currently affecting ocular health or which in the Investigator's opinion may have an effect on ocular health during the course of the study.

• Subjects using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.

• Subjects with an active ocular disease or who are using any ocular medication.

• Subjects with any grade 2 or greater finding during the slit lamp examination. Subjects with corneal infiltrates, of ANY GRADE, are not eligible.

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

• Subjects who are allergic to any component in the study care products.

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• Investigational Toric Lens
Bausch & Lomb investigational toric contact lens worn on a daily wear basis for 2 weeks.
• PureVision Toric Lens
Currently marked Bausch & Lomb PureVision Toric Lens worn on a daily wear basis for 2 weeks.

Locations

Country	Name	City	State
United States	Bausch & Lomb	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	Percentage of Eyes With Absolute Lens Rotation = 10 Degrees.		2 weeks
Primary	Visual Acuity	Visual acuity was assessed by distance high contrast logarithm of the minimum angle of resolution (logMAR).	2 weeks
Secondary	Symptoms and Complaints	Symptoms/complaints were assessed on a scale from 0 to 100, with 0 denoting unfavorable symptoms/complaints. Symptoms/complaints were recorded at each post-dispensing visit based on the subject's experience with the study lens worn prior to the visit. The symptoms/complaints parameters were: Burning/stinging upon insertion; Comfort upon insertion, Overall comfort, and Comfort at the end of the day; Ease of handling/insertion, and Ease of handling/removal; Dryness; Itchiness; Redness; Vision; Lens cleanliness; and Overall impression.	2 weeks
Secondary	Percentage of Eyes With > Grade 2 Slit Lamp Findings	Graded slit lamp findings for each eye, including epithelial edema, epithelial microcysts, corneal staining, limbal and bulbar injections, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates were graded for severity on a scale from 0 (No Finding) to 4 (Severe Finding). The outcome measure is any finding > grade 2, across abnormalities.	2 weeks