A Study to Assess the Safety and Efficacy of a Daily Disposable Contact Lens

Myopia Clinical Trial

Official title:

A Study to Assess the Safety and Efficacy of a Daily Disposable Contact Lens

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01130974
• Other study ID #: 639
• Status: Completed
• Phase: N/A
• First received: May 25, 2010
• Last updated: November 8, 2013
• Start date: April 2010
• Est. completion date: September 2010

Study information

• Verified date: November 2013
• Source: Bausch & Lomb Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to evaluate the safety and efficacy of the Bausch & Lomb daily disposable tint contact lens (Test) compared to a currently marketed daily disposable cosmetic tint contact lens (Control).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: September 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• 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 wearers of soft contact lenses, wear a lens in each eye, and each lens must be of the same manufacture and brand.

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

• Subjects must be of Asian descent.

• Subjects must require plano or myopic correction and must require contact lens correction from plano to -6.00 D in both eyes.

Exclusion Criteria:

• Subjects who have any systemic disease affecting ocular health.

• 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 are using any ocular medication.

• 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 with minor peripheral corneal scarring (that does not extend into the central area), that in the Investigator's judgment, does not interfere with contact lens wear, are eligible for this study.

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

• Subjects who are adapted wearers of 1-Day Acuvue Define daily disposable cosmetic tint contact lenses.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• Bausch & Lomb contact lens
Bausch & Lomb daily disposable cosmetic tint contact lens
• Marketed daily disposable contact lens
Marketed daily disposable cosmetic tint contact lens

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	Slit Lamp Findings	Graded Slit lamp findings (epithelial edema, epithelial microcysts, corneal staining, limbal injection, bulbar injection, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates) > grade 2 over all follow-up visits, summarizes the worst case over all follow-up visits. Graded 0-4 with 0=none and 4=severe	Summarized over all follow-up visits through 1 month	No
Primary	logMAR Visual Acuity (VA)	Non-inferiority of distance high contrast logMAR lens VA. A negative value indicates improved VA. Lens VA was established for All Study, Dispensed, 2-Week Follow-up Visit, and 1-Month Follow-up Visit	Summarized over all visits, and dispensed visit	No
Primary	logMAR Visual Acuity (VA)	Non-inferiority of distance high contrast logMAR lens VA. A negative value indicates improved VA. Lens VA was established for All Study, Dispensed, 2-Week Follow-up Visit, and 1-Month Follow-up Visit	2 week and 1 month follow-up	No
Secondary	Lens Wettability	Lens wettability was rated as Grade 4-0. Grade 4 = 100% of anterior surface wettable (optimal); Grade 3 = presence of small (< 0.1 mm), individual, discrete non-wetting areas (slight); Grade 2 = presence of single area of non-wetting between 0.1 mm and 0.5 mm in size (mild); Grade 1 = presence of several areas on non-wetting, each between 0.1 mm and 0.5 mm in size (moderate); Grade 0 = presence of one or more non-wetting areas > 0.5 mm in size (severe). Suboptimal lens wettability was defined as a rating other than Grade 4, ie slight, mild, moderate, or severe ratings. Over All Visits summarizes the worst case over the dispensing and all follow-up visits.	Summarized over all follow-up visits through 1 month	No
Secondary	Lens Deposits	Degree of lens deposits was assessed as none, light, medium, or heavy. Suboptimal lens deposits were defined as a degree rating of medium or heavy. Measured over all visits through one month	Summarized over all follow-up visits through one month	No
Secondary	Lens Centration	Lens centration was assessed as excellent(fully centered), good (slight decentration, no corneal exposure), fair (decentration, intermittent corneal exposure), or poor (incomplete corneal coverage and/or edge lift).; Suboptimal lens centration was defined as a rating other than excellent.	Summarized over all follow-up visits through 1 month	No
Secondary	Lens Movement	Lens movement was assessed as adequate, excessive (> 0.6 mm), insufficient (< 0.2 mm), or adherence. Suboptimal lens movement was defined as a rating other than adequate.	Summarized over all follow-up visits through one month	No
Secondary	Symptoms & Complaints	Subject symptoms/complaints were assessed on a scale from 0 to 100, with 0 denoting least favorable symptoms/complaints and 100 being the most favorable score.	Summarized over all follow-up visits through one month	No