Three Daily Wear Monthly Replacement Silicone Hydrogel Contact Lenses With Two Multi-purpose Disinfecting Solution Combinations

Refractive Errors Clinical Trial

Official title:

Clinical Biocompatibility of Three Daily Wear Monthly Replacement Silicone Hydrogel Contact Lenses With Two Multi-purpose Disinfecting Solution Combinations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04789382
• Other study ID #: CLY935-E007
• Status: Completed
• Phase: N/A
• Start date: April 7, 2021
• Est. completion date: May 7, 2021

Study information

• Verified date: May 2022
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate corneal staining observed after 2 hours of wear with an investigational contact lens against both PureVision contact lenses pre-cycled with Biotrue and Biofinity contact lenses pre-cycled with RepleniSH.

Description:

Subjects will be randomized in a 1:1:1:1 manner to receive one of 4 regimen sequences with lens and multipurpose disinfection solution (MPDS) combinations. The expected duration of subject participation in the study is approximately 1 week with 2 study visit days.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: May 7, 2021
• Est. primary completion date: May 7, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

• Understand and sign an Informed Consent;

• Successful wear 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 of less than or equal to 1.50 diopter (D) in each eye;

• Best corrected visual acuity (BCVA) better than or equal to 20/25 Snellen in each eye;

• Willing to stop wearing habitual contact lenses for the duration of study lens exposure and during the washout period.

• Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria:

• Any eye condition or disease (including systemic) that contraindicates contact lens wear, as determined by the Investigator;

• Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator;

• Eye surgery, as specified in the protocol;

• Dry eye; use of artificial tears, as specified in the protocol;

• Other protocol-specified exclusion criteria may apply.

Related Conditions & MeSH terms

• Refractive Errors

Intervention

Device:
• LID018869+RepleniSH
Lehfilcon A silicone hydrogel spherical contact lens pre-cycled (pre-soaked prior to dispense) with OPTI-FREE® RepleniSH® multi-purpose disinfecting solution (RepleniSH)
• LID018869+Biotrue
Lehfilcon A silicone hydrogel spherical contact lens pre-cycled (pre-soaked prior to dispense) with Biotrue® multi-purpose solution (Biotrue)
• Biofinity+RepleniSH
Comfilcon A silicone hydrogel spherical contact lens pre-cycled (pre-soaked prior to dispense) with OPTI-FREE® RepleniSH® multi-purpose disinfecting solution (RepleniSH)
• PV+Biotrue
Balafilcon A silicone hydrogel spherical contact lens pre-cycled (pre-soaked prior to dispense) with Biotrue® multi-purpose solution (Biotrue)

Locations

Country	Name	City	State
United States	Alcon Investigator 6565	Maitland	Florida

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 Corneal Staining	A slit lamp examination was performed by the investigator to assess 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. Each eye was treated differently and was graded separately. No hypotheses were formulated; no inferences were made, and only descriptive statistics were used in the reporting.	Hour 2 (each wear period)