Clinical Evaluation of Investigational Multifocal Toric Contact Lenses

Presbyopia Clinical Trial

Official title:

Clinical Evaluation of Biofinity Multifocal Toric Contact Lenses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03519282
• Other study ID #: CV-18-11
• Status: Completed
• Phase: N/A
• Start date: April 25, 2018
• Est. completion date: July 24, 2018

Study information

• Verified date: April 2020
• Source: Coopervision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This non-dispensing study is to evaluate the clinical performance of a test multifocal toric silicone hydrogel contact lens compared to a marketed multifocal toric contact lens (control).

Description:

This non-dispensing study is to evaluate the clinical performance of a test multifocal toric silicone hydrogel contact lens compared to a marketed multifocal toric contact lens (control).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: July 24, 2018
• Est. primary completion date: July 24, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

Inclusion Criteria:

• Has had a self-reported oculo-visual examination in the last two years.

• Is aged 40-75 years, inclusive and has full legal capacity to volunteer.

• Has read and understood the participant information sheet.

• Is willing and able to follow instructions and maintain the appointment schedule.

• Is able to participate in Parts A and B related to this work.

• Has a contact lens spherical prescription between +10.00 to -10.00D (inclusive).

• Has an Add component to their spectacle refraction (between +0.75 and +2.50DS).

• Has astigmatism between -0.75 and -5.75DC (based on the vertexed ocular refraction in each eye.

• Can be satisfactorily fitted with the study lenses.

• Is correctable to a visual acuity of 20/40 (0.30 logMAR) or better (in each eye) with their habitual vision correction or 20/25 (0.10 logMAR) best-corrected.

• They have successfully worn soft contact lenses in the last six months

• Has clear corneas and no active ocular disease.

• Has not worn lenses for at least 12 hours before the examination.

• Has an up-to-date pair of spectacles.

Exclusion Criteria:

• Has never worn contact lenses before.

• Has any systemic disease affecting ocular health.

• Is using any systemic or topical medications that will affect ocular health.

• Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would, in the opinion of the investigator, affect the wearing of contact lenses.

• Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye that would, in the opinion of the investigator, be problematic for their participation in the study.

• Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars.

• Is aphakic.

• Has undergone corneal refractive surgery.

• Has a history of anaphylaxis or severe allergic reaction.

• Has diabetes or an infectious or immunosuppressive disease which could contraindicate contact lens wear or pose a risk to the investigator.

• They are pregnant or breast-feeding.

• Is participating in any other type of eye-related clinical or research study.

Related Conditions & MeSH terms

• Astigmatism
• Presbyopia

Intervention

Device:
• comfilcon A multifocal toric lens
contact lens
• omafilcon A Multifocal Toric Lens
contact lens

Locations

Country	Name	City	State
United Kingdom	Eurolens Research	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Coopervision, Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Acuity	Visual Acuity (measured in LogMAR)	Up to 2 hours
Secondary	Assessment of Visual Performance: Distance Navigation Tasks for Vision Quality and Clarity	Subjective assessment of visual performance for distance navigation tasks for vision quality and clarity was assessed on a scale 0-100, 0=poor, 100=excellent.	Up to 2 hours
Secondary	Assessment of Visual Performance: Intermediate Task for Vision Quality and Clarity	Subjective assessment of visual performance for intermediate task for vision quality and clarity was assessed on a scale 0-100, 0=poor, 100=excellent.	Up to 2 hours
Secondary	Assessment of Visual Performance: Near Task for Vision Quality and Clarity	Subjective assessment of visual performance for near task for vision quality and clarity was assessed on a scale 0-100, 0=poor, 100=excellent.	Up to 2 hours