Regulatory Studies for ISO Certification

• DETERMINATION OF PHYSICAL COMPATIBILITY OF SOLUTION WITH CONTACT LENSES
To determine the physical compatibility between the study solution and conventional hydrogel, silicone hydrogel and rigid gas permeable contact lenses, evaluating the contact lenses parameters like: diameter, power, radius, physical appearance and spectral transmittance.
References:

UNE-EN ISO 11981:2018
UNE-EN ISO 18369-1:2018
UNE-EN ISO 18369-2:2013
UNE-EN ISO 18369-3:2018
UNE-EN ISO 18369-4:2018

• DETERMINATION OF THE SOLUTION RINSE FROM THE CONTACT LENS SURFACE
The objective of this study is to determine rinsing capacity of the solution from conventional hydrogel contact lenses, silicone hydrogel and rigid gas permeable contact lenses after being used for cleaning and storage, following the manufacturer instruction for use.
according to UNE-EN ISO 11981:2018 normative

• DETERMINATION OF REWETTING EFFICACY OF SOLUTION ON THE SURFACE OF CONTACT LENSES
The objective of this study is to assess whether the solution decrease the ratio of dryness of gas permeable rigid contact lenses, hydrophilic and Hydrogel of silicone, maintaining more lubricated lens and therefore improving the lens wearing using as control lenses immersed in normalized isotonic saline.


• DRYNESS SYMPTOMS IMPROVING EVALUATION AFTER THE USE OF MOISTURE solution DROPS
To evaluate the capability of MOISTURE DROPS to improve the OCULAR dryness symptomatology.

The study is conducted following the tenets of Helsinki declaration, renewed and revised in 2013.
The measurements are done before and 15 days after the use artificial tears. It is evaluated the dryness symptomatology with OSDI (Ocular Surface Disease Index) and with the visual analogue scale (VAS) where the patient will score their ocular comfort from 0 to 100 (being 0 maximum discomfort and 100 total comfort) before and after the use of Eye Drops for 15 days.
According to UNE-EN ISO 11981:2018 normative.


• DETERMINATION OF THE CAPACITY TO REMOVE LIPIDS FROM CONTACT LENSES BY CLEAN SOLUTION.

Determine by an in vitro study the cleaning efficiency of the solution in the elimination of lipids in conventional hydrogel, silicone hydrogel and rigid gas permeable contact lenses.
The protocol followed is a modification of ISO 11986: 2018

• DETERMINATION OF THE CLEAN SOLUTION CAPABILITY FOR PROTEINS REMOVAL
To evaluate the capability of clean solution , to remove proteins from different types of contact lenses.
The protocol followed is a modification of ISO 11986: 2018

• DETERMINATION OF CONSERVATION PERIOD OF CONTACT LENSES IN A CONSERVATION OR MAINTENANCE SOLUTION.
The objective of this study is to determine if conventional hydrogel contact lenses, silicone hydrogel and rigid gas permeable lenses, maintain their optical and physical properties when kept it in the MAINTENANCE solution for 30 days.

References:

UNE-EN ISO 11981:2018
UNE-EN ISO 18369-3: 2018
UNE-EN ISO 18369-1:2018
UNE-EN ISO 18369-2:2013
UNE-EN ISO 18369-3:2018
UNE-EN ISO 18369-4:2018

• USABILITY VALIDATION OF SOLUTION
The purpose of the current study was to evaluate the usability of the product to confirm its ease of use by users.

UNE-EN 62366-1:2015

IEC 62366-1:2015/COR1:2016

UNE-EN ISO 11978:2018