Clinical Biocompatibility Evaluation of Contact Lens Coatings

Refractive Errors Clinical Trial

Official title:

Clinical Biocompatibility Evaluation of Contact Lens Coatings

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03034928
• Other study ID #: CLY935-E002
• Status: Completed
• Phase: N/A
• Start date: February 14, 2017
• Est. completion date: March 14, 2017

Study information

• Verified date: February 2020
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective is to evaluate corneal staining observed after 2 hours of wear with contact lenses with investigational coating against PureVision™ lenses, all pre-cycled with OPTI-FREE® RepleniSH® multi-purpose disinfection solution.

Description:

In this contralateral crossover study, qualifying subjects will wear a total of 2 pairs of study contact lenses. Lenses will be worn according to a randomized lens sequence assignment. Each pair will consist of a test lens (Test 1 or Test 2) and a control lens.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: March 14, 2017
• Est. primary completion date: March 14, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Able to understand and must sign an Informed Consent;

• Successful wearer of spherical soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months;

• Manifest cylinder less than or equal to 1.50 diopter (D) in each eye;

• Best Corrected Visual Acuity (BCVA) 20/25 or better in each eye;

• VA with habitual spectacles 20/40 in both eyes (OU) or better and willing to wear spectacles as needed during the washout period and during study lens exposure;

• Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

• Any anterior segment infection, inflammation, abnormality or disease that contraindicates contact lens wear;

• Any use of systemic or ocular medications for which contact lens wear could be contraindicated;

• History of refractive surgery or plan to have refractive surgery during the study or irregular cornea in either eye;

• Ocular or intra-ocular surgery (excluding placement of punctal plugs) within the previous 12 months or planned during the study;

• Current or history of pathologically dry eye in either eye that would preclude contact lens wear;

• Current or history of herpetic keratitis in either eye;

• Eye injury in either eye within 12 weeks immediately prior to enrollment;

• History of intolerance or hypersensitivity to any component of the study lenses or solutions;

• Habitual contact lenses worn in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment;

• Use of topical ocular medications and artificial tear or rewetting drops that would require instillation during contact lens wear;

• Other protocol-specified exclusion criteria may apply.

Related Conditions & MeSH terms

• Ametropia
• Refractive Errors

Intervention

Device:
• Contact lens with investigational coating 1
Contact lens with investigational coating 1 pre-cycled in OPTI-FREE® RepleniSH® Multi-Purpose Disinfecting Solution (MPDS)
• Balafilcon A contact lens
Balafilcon A contact lens pre-cycled OPTI-FREE® RepleniSH® MPDS
• OPTI-FREE® RepleniSH® MPDS
Multipurpose contact lens solution
• Contact lens with investigational coating 2
Contact lens with investigational coating 2 pre-cycled in OPTI-FREE® RepleniSH® MPDS

Locations

Country	Name	City	State
United States	Alcon Investigative Site	Johns Creek	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average Percent Area of Solution-related Corneal Staining	Percent of solution-related corneal staining area was assessed first in each of the 5 corneal regions: central, superior, nasal, inferior, and temporal. The average of corneal staining area was then calculated as the average over all 5 regions. A higher percentage reflects more damage to the corneal surface. Both eyes contributed to the analysis. No hypotheses were formulated; no inferences were made and only descriptive statistics were used in the reporting.	Day 1 after 2 hours of wear, each product