Evaluation of ocular health and comfort of spectacle wearers for three months

Not Applicable

Recruiting

• Conditions: Ocular health; Ocular comfort/discomfort; Eye - Normal eye development and function

• Registration Number: ACTRN12612000151831
• Lead Sponsor: Brien Holden Vision Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-02-03
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 100

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 participating.
Have a current pair of pre-prescribed spectacles
Is correctable to at least 6/12 (20/40) or better in each eye with spectacles.
Have not worn contact lenses within the previous twelve months (They may have worn lenses not totalling more than two weeks in the past twelve months)

Exclusion Criteria

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ocular health by asessing ocular redness, corneal and conjunctival fluorescein staining using slitlamp examination of the anterior eye[Measured at Baseline, 2 weeks after Baseline, 1 Month after Baseline and 3 Months after Baseline. It may also be measured at any unscheduled visits during the trial.]

Secondary Outcome Measures

Name	Time	Method
Subjective comfort ratings measured with a Numeric Rating Scale of 1 to 10.[Measured at Baseline, 2 weeks after Baseline, 1 Month after Baseline and 3 Months after Baseline. It may also be measured at any unscheduled visits during the trial.]