None listed
Conditions
Brief summary
this trial will investigate the effect of preservatives in comfort eye-drops on corneal epithelial cells
Interventions
This study is divided into two stages. Participants can complete just one stage or both stages.
Stage 1: Five participants will undergo a baseline visit and three further scheduled visits (visits 1, 2, and 3). At each visit, visual acuity will be measured and the ocular surface will be assessed.
-Baseline: The corneal surface of each eye will be gently washed with a saline rinse and shed corneal epithelial cells are collected in the retained solution. This procedure is performed to familiarise
This study is divided into two stages. Participants can complete just one stage or both stages. Stage 1: Five participants will undergo a baseline visit and three further scheduled visits (visits 1, 2, and 3). At each visit, visual acuity will be measured and the ocular surface will be assessed. -Baseline: The corneal surface of each eye will be gently washed with a saline rinse and shed corneal epithelial cells are collected in the retained solution. This procedure is performed to familiarise the participant to the eye wash procedure. -Visit 1: Following a 48 hour wash-out (no use of contact lenses or ocular eye drops) participants will have the corneal surface of each eye gently washed with a saline rinse and shed corneal epithelial cells are collected in the retained solution. These corneal epithelial cells will be counted using two instruments, the confocal microscopy (manual cell count) and the flow-cytometer (semi-automated cell count), with instrument allocated for each eye by randomisation. -Visit 2: Following a 48 hour wash-out (no use of contact lenses or ocular eye drops) plano (lens with no power)PureVision [Registered trade mark] contact lenses soaked overnight in renu [Registered trade mark] fresh [Trade mark] solution are inserted bilaterally. -Visit 3: Lenses are removed four hours after insertion and the corneal surface of each eye will be gently washed with a saline rinse and shed corneal epithelial cells are collected in the retained solution. These corneal epithelial cells will be counted using two instruments, the confocal microscope (manual cell count) and the flow-cytometer (semi-automated cell count), with instrument allocated for each eye by randomisation. Stage 2: Twenty participants will undergo a baseline visit and two further scheduled visits (visits 1 and 2). At each visit, visual acuity will be measured and the ocular surface will be assessed. -Baseline: The corneal surface of each eye will be gently washed with a saline rinse and shed corneal epithelial cells are collected in the retained solution. This procedure is performed to familiarise the participant to the eye wash procedure. If participant has completed stage 1, this procedure is not repeated. Participants are randomly allocated either Revital Eyes [Registered trade mark] (preservative- BAK) or Refresh Tears Plus [Registered trade mark] (preservative-purite), lubricating eye drops. These will be used four times per day for two weeks unilaterally (in one eye only), with the eye designated for eye drop use randomly allocated. -Visit 1: After 7 days of unilateral eye drop use, the corneal surface of each eye will be gently washed with a saline rinse and shed corneal epithelial cells are collected in the retained solution. These corneal epithelial cells for eye will be counted using flow-cytometry. -Visit 2: After 14 days of unilateral eye drop use, the corneal surface of each eye will be gently washed with a saline rinse and shed corneal epithelial cells are collected in the retained solution. These corneal epithelial cells for eye will be counted using flow-cytometry.
Sponsors
Allergan, Inc
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Diagnosis
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Outcome results
None listed