Evaluation of effect of eye drops on healthy volunteers
Effect of eye drops on accommodative response and pupil size in healthy volunteers
Brien Holden Vision Institute
30 participants
Mar 2, 2020
Interventional
Conditions
Summary
This clinical trial is aimed to determine the effect of topically applied eye drops on focusing power of the eye and size of the eye's aperture (pupil size). This study consists of two arms. Four types of eye drops will be tested in each arm. Each different type of drops will be instilled only once and drops will be instilled only in one eye. After instillation of drops, participants will be monitored over a duration of 24 hours. During these 24 hours there will be a total of four scheduled visits. Only standard optometric procedures will be conducted during these visits. Measurements of focusing power of the eye and pupil size will be conducted using non-invasive instruments.
Eligibility
Inclusion Criteria4
- (i) Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent.
- (ii) Be between 18 to 35 years old, male or female.
- (iii) Willing to comply with instillation of eye drops and clinical trial visit schedule as directed by the Investigator.
- (iv) Have ocular health findings considered to be “normal”.
Exclusion Criteria13
- (i) Any pre-existing ocular irritation, injury or condition (including infection or disease).
- (ii)Any systemic disease that adversely affects ocular health e.g. diabetes, Graves disease, and autoimmune 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.
- (iii) Use of or a need for concurrent category S3 and above ocular medication at enrolment and/or during the clinical trial.
- (iv) 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.
- (v) Eye surgery within 12 weeks immediately prior to enrolment for this trial.
- (vi) Previous corneal refractive surgery.
- (vii) Known allergy or intolerance to ingredients in any of the clinical trial products (atropine and caffeine).
- (viii) Currently enrolled in another clinical trial.
- (ix) Participation in a clinical trial within the previous 2 weeks for dispensing studies and 48 hours between in-house studies.
- (x) Pregnancy and breastfeeding*.
- 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.
- Formal testing of pregnancy is not required. A participant’s verbal report is sufficient.
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Interventions
Topically applied eye drops evaluated in two arms. The products and concentrations of arm 1 and arm 2 are given in the private notes section. Concentrations and type of eyes drops are given in the private notes section Single drop will be instilled to one eye only Single administration Optometrist will instill the eye drops Eye drops will be instilled four times over a period of four months Drops will be instilled at the clinic in Brien Holden Vision Institute Not applicable as the drops will be instilled by the optometrist at the clinic There is a minimum of four nights washout between the eye drops
Locations(1)
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ACTRN12620000433909