Evaluation of the Performance of Non-molded Soft Contact Lenses

University of Waterloo38 enrolled

Overview

To evaluate the performance of the study soft lens for vision, comfort, physiology and lens surface properties.

To evaluate the performance of the study soft lens for vision, comfort, physiology and lens surface properties in a group of participants who present with lens related changes.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Ametropia

Interventions

Soft contact lensDEVICE

Soft contact lens

Eligibility

Sex: ALLMin age: 17 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Male or female, good health, age \>17yrs, able to wear contact lenses as primary vision correction, able to see well and achieve good fit with study lens, has understood \& signed consent form. Exclusion Criteria: * Has active ocular disease, uses topical eye medication, wears gas permeable/silicone hydrogel /overnight wear contact lenses, is a participant in another clinical study, is deemed unsuitable for soft contact lens wear.

Locations (1)

Centre for Contact Lens Research, University of Waterloo,

Waterloo, Ontario, Canada

Outcomes

Primary Outcomes

Visual Acuity

level of vision measured using high contrast acuity chart, higher (more positive)logMAR indicates worse vision.

Time frame: baseline

Visual Acuity

level of vision measured using high contrast acuity chart, higher (more positive)logMAR indicates worse vision.

Time frame: 9 month

Neovascularisation

length of the blood vessels entering the superior cornea, higher number means longer blood vessel penetration.

Time frame: baseline

Neovascularization

length of the blood vessels entering the superior cornea, higher number means longer blood vessel penetration.

Time frame: 9 month

Data from ClinicalTrials.gov

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