Evaluation of ocular health and comfort in non spectacle wearer and non contact lens wearers (emmetropes) for three months
Prospective, single group clinical trial where a minimum of 40 participants (non spectacle and non contact lens wearers) will be assessed for a total of three months, for ocular surface characteristics and subjective responses such as comfort
Brien Holden Vision Institute
40 participants
Feb 28, 2012
Observational
Conditions
Summary
The results from this study will allow for further understanding of the ocular surface response and subjective comfort responses of the emmetropic population. The insight into the subjective comfort responses of this population can further enhance knowledge in the subjective comfort responses of the spectacle and contact lens wearing populations. The hypothesis of this study is that there will be no difference in ocular health and comfort in emmetropes over the course of three months.
Eligibility
Inclusion Criteria5
- 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 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 participating.
- Have a ocular prescription between +/- 0.50D (inclusive), ie no need for correction
Exclusion Criteria9
- Any pre-existing ocular irritation, injury or condition (including infection or disease) of the cornea, conjunctiva or eyelids.
- Any systemic disease that adversely affects ocular health e.g. diabetes, Graves disease, and auto immune diseases such as ankylosing spondylitis, multiple sclerosis, Sjogrens 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
- Eye surgery within 12 weeks immediately prior to enrolment for this trial.
- Previous corneal refractive surgery.
- Currently enrolled in another clinical trial.
- Participation in a clinical trial within the previous 2 weeks
- Pregnancy
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Interventions
Ocular health (by visual acuity measurements, autorefraction/subjective refraction, slitlamp examination of the anterior eye) and comfort (by subjective comfort questionnaires) of non spectacle and non contact lens wearers are assessed at the baseline, 2 hours, 2 weeks, 1 month and 3 months after the baseline over the course of the trial. The number of recruited participants may change to ensure the drop out number does not reduce the sample size to a level below what is required for the demonstration of statistical power and significance.
Locations(1)
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ACTRN12612000154808