A comparison of two commercially-available eye drops on corneal epithelial cell shedding when eye drops are used in one eye for two weeks in healthy participants

Not Applicable

Withdrawn

• Conditions: Corneal epithelium cell shedding; Eye - Normal eye development and function

• Registration Number: ACTRN12612000145808
• Lead Sponsor: Allergan, Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-02-01
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Withdrawn
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent.
-Be at least 18 years old, male or female.
-Willing to comply with the wearing and clinical trial visit schedule as directed by the Investigator.
-Have ocular health findings considered to be normal” and which would not prevent the participant from safely wearing contact lenses.
-Be an experienced contact lens wearer (but willing to not wear contact lenses for the duration of the trial, except, during stage visits 2-3) or a non lens wearer (but willing to wear plano lenses for approximately four hours on one day during stage 1 visits 2-3).

Exclusion Criteria

-Any pre-existing ocular irritation, injury or condition (including infection or disease) of the cornea, conjunctiva or eyelids that would preclude contact lens fitting and safe wearing of contact lenses.
-Any systemic disease that adversely affects ocular health e.g. diabetes, Graves disease, and auto immune diseases such as ankylosing spondylitis, multiple sclerosis, Sjögrens syndrome and systemic lupus erythematosus. Conditions such as systemic hypertension and arthritis do not automatically exclude prospective participants.
-Use of or a need for concurrent category S3 and above ocular medication at enrolment and/or during the clinical trial.
-Use of or a need for any systemic medication or topical medications which may alter normal ocular findings / are known to affect a participant’s ocular health / physiology or contact lens performance either in an adverse or beneficial manner at enrolment and/or during the clinical trial.
NB: Systemic antihistamines are allowed on an as needed basis”, provided they are not used prophylactically during the trial and at least 24 hours before the clinical trial product is used.
-Eye surgery within 12 weeks immediately prior to enrolment for this trial.
-Previous corneal refractive surgery.
-Known allergy or intolerance to ingredients in any of the clinical trial products.
-Currently enrolled in another clinical trial.
-Participation in a clinical trial within the previous 2 weeks for dispensing studies and 48 hours between in-house studies.
-Not willing to not wear contact lenses for the duration of the clinical trial.
-Pregnancy* (either at enrolment or during the course of the trial). Formal testing of pregnancy is not required. A participant’s verbal report is sufficient
-The Investigator may, at his / her discretion, exclude anyone who they believe may not be able to fulfil the clinical trial requirements or it is believed to be in the participant’s best interests.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine if there is a difference in corneal epithelial cell shedding between eyes exposed to tear-supplements preserved with either BAK or Purite. Epithelial cells shed in the retained solution from the ocular saline wash will be passed through the Attune Acoustic focussing Flow cytometer and cells will be counted using Attune Flow cytometer software[After 7 and 14 days of lubricating eye drop use]

Secondary Outcome Measures

Name	Time	Method
To validate the flow-cytometer as a method of counting collected human corneal epithelial cells[After 4 hours of contact lens wear]