A Study to Evaluate the Product Performance of a New Silicone Hydrogel Contact Lens

Myopia Clinical Trial

Official title:

A Study to Evaluate the Product Performance of a New Silicone Hydrogel Contact Lens

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01873846
• Other study ID #: 817
• Status: Completed
• Phase: N/A
• Start date: April 2013
• Est. completion date: July 2013

Study information

• Verified date: July 2019
• 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 a new silicone hydrogel soft contact lens when worn by current soft contact lens wearers on a daily wear basis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: July 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• Subjects must be correctable through spherocylindrical refraction to 32 letters (0.3 logMAR) or better (distance, high contrast) in each eye

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

• Subjects must be adapted lens wearers and 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 from -0.25 D to -6.00 D in each eye.

• Subject must wear their current lenses for a minimum of 12 hours per day at least four days per week.

• Subjects must spend at least 3 hours each workday using a computer or electronic device (ie, smartphones, tablets, eReaders).

• Subjects must habitually wear soft contact lens.

• Subject must have no active ocular disease or allergic conjunctivitis.

• Subject must not be using any topical ocular medications.

• Subjects must be bothered (occasionally or frequently) by blurriness or fluctuations in vision with their current contact lenses.

• Subjects must habitually use a lens care product for cleaning, disinfection, and storage.

Exclusion Criteria:

• Subjects who have worn gas permeable (GP) contact lenses within the last 30 days or who have worn polymethylmethacrylate (PMMA) lenses within the last three months.

• 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 who are not correctable to 32 letters (0.3 logMAR) in each eye with soft spherical contact lenses.

• Subjects who are presbyopic or currently wear monovision, multifocal, or toric contact lenses.

• Subjects with an ocular astigmatism of 1.00 D or greater in either eye.

• Subjects with anisometropia (spherical equivalent) of 2.00 D or greater in either eye.

• 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 with any scar or neovascularization within the central 4 mm of the cornea.

• Subjects who are aphakic.

• Subjects who are amblyopic.

• Subjects who have had any corneal surgery (eg, refractive surgery).

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

• Subjects who are bothered by blurriness or fluctuations in vision due to itchy eyes, something on or under the lens, allergies, or cigarette smoke.

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• Silicone Hydrogel Contact Lens

Locations

Country	Name	City	State
United States	Bausch & Lomb Incorporated	Madison	New Jersey

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	Preference Question: How Would You Say These Contact Lenses Compare Overall With the Contact Lenses You Usually Use?	Participants will respond to a survey regarding their experience wearing the Test Lens after 7 days of wear. Participants were asked to answer the following question: "How would you say these contact lenses compare overall with the contact lenses you usually use?" Prefer study lenses Prefer usual lenses About the same as usual lenses	7 days
Primary	Preference Question: These Contact Lenses Deliver Exceptional Clarity and Comfort All Day Long.	Participants will respond to a survey regarding their experience wearing the Test Lens after 7 days of wear. Participants were asked to assess the following statement with respect to their usual contact lenses: "These contact lenses deliver exceptional clarity and comfort all day long." Prefer study lenses Prefer usual lenses About the same as usual lenses	7 days
Primary	Preference Question: These Contact Lenses Help Maintain Healthy, White Eyes.	Participants will respond to a survey regarding their experience wearing the Test Lens after 7 days of wear. Participants were asked to assess the following statement with respect to their usual contact lenses: "These contact lenses help maintain healthy, white eyes." Prefer study lenses Prefer usual lenses About the same as usual lenses	7 days
Secondary	Lens Performance Assessment	High Contrast Distance logMAR Lens VA Change From Baseline to Week 2.	2 weeks
Secondary	Any Graded Slit Lamp Finding > 2	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). Corneal staining grades were computed as the maximum grade over grades taken within each of five different eye locations (central, inferior, nasal, superior, and temporal). Eyes with multiple visits are counted once for the highest grade.	2 weeks