None listed
Conditions
Brief summary
This research study focuses on evaluating ocular (eye) comfort and tear proteins, with the use of daily disposable contact lenses. Contact lenses provide improved vision and daily convenience for many people around the world. However, about half of new contact lens wearers stop contact lens wear within the first few months. One of the most common reasons is because of challenges with the comfort of the lenses. Recent research has shown that some people who experience discomfort with contact lenses have different levels of certain proteins associated with inflammation in their tears. This study aims to examine the changes to pro-inflammatory proteins (cytokines) in tears in people new to wearing contact lenses, over a period of six months. The primary aim of this project, is to determine whether the presence of certain proteins in the tears can be predictive of people who are more likely to experience discomfort with contact lens wear.
Interventions
The study intervention will be CooperVision Clariti 1 Day and Clariti 1 Day Toric contact lenses (CLs), which provide improved visual clarity by correcting the refractive error of the eyes. The CooperVision Clariti 1 Day CLs, corrects the refractive errors, nearsightedness (myopia) and farsightedness (hyperopia), while the CooperVision Clariti 1 Day Toric CLs, additionally corrects refractive errors associated with astigmatism. Participants with nearsightedness or farsightedness and astigmatism
The study intervention will be CooperVision Clariti 1 Day and Clariti 1 Day Toric contact lenses (CLs), which provide improved visual clarity by correcting the refractive error of the eyes. The CooperVision Clariti 1 Day CLs, corrects the refractive errors, nearsightedness (myopia) and farsightedness (hyperopia), while the CooperVision Clariti 1 Day Toric CLs, additionally corrects refractive errors associated with astigmatism. Participants with nearsightedness or farsightedness and astigmatism less than -0.75DC will be fitted with CooperVision Clariti 1 day CLs. Participants with nearsightedness or farsightedness and astigmatism equal or greater than -0.75 DC will be fitted with Clariti 1 Day toric CLs. Both lenses are commercially available daily disposable silicone-hydrogel CLs, to be worn by participants on a daily wear only basis, at least four times per week (at least eight hours per day) over a six month period. Participants recruited for this study will be naïve to CL wear (i.e., have not worn CLs before), who are interested in wearing CLs for the first time. The study researchers, who are qualified optometrists, will teach eligible participants how to apply and remove the CLs, before being provided with contact lenses to use independently. The participants will have to demonstrate their ability to perform these techniques safely on their own. Eligible participants will be provided with approximately 180 pairs of Clariti 1 Day and Clariti 1 Day Toric CLs, including a suitable number of spare pairs, over the study duration. Participants will be required to return all unused contact lenses at each follow-up visit to monitor contact lens wear compliance. This study will evaluate the relationship between tear proteins and eye comfort during soft CL wear. The primary aim will be to determine whether certain tear proteins are predictive of individuals who develop discomfort with CLs at the end of their daily wear period. At the conclusion of the study, participants will be 'grouped' in to symptomatic (those participants who experience discomfort) and asymptomatic (those who do not experience discomfort) CLs wearers, based upon CLs wear time and responses to subjective questionnaires. Further inter-group comparisons will be made between these two groups.
Sponsors
The University of Melbourne
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Male or female, aged 18-45 years of age; 2. Provide written informed consent and documentation, in accordance with privacy requirements, obtained prior to performing any study procedures; 3. Ability to understand and follow study instruction, with the intention of completing all of the required study visits; 4. In good general health; 5. Have never worn CLs; 6. Have a CL spherical prescription range of -0.50 to -6.00 D and +0.50 to +4.00 D and a CL cylindrical prescription range of up to -2.25 DC. 7. An acceptable soft CL fit and vision in both eyes with Clariti 1 Day contact lenses (sphere or toric), per the judgement of the study investigator; 8. Demonstrated capacity for independent, competent and safe CL application and removal at Visit 2, per the judgement of the study investigator; 9. Be motivated and willing to wear CLs for a minimum of four days per week, eight hours per day, over the study duration; 10. Best-corrected visual acuity with CL correction of at least 6/9 (20/30) in each eye; 11. Not regularly (once per day only) using artificial tear eye drops in the month prior to enrolment, or planned over the course of the study.
Exclusion criteria
1. Have any known active ocular disease and/or infection (including DED); 2. Presence of any of the following conditions: active ocular inflammation, active ocular allergy, a corneal disorder or abnormality that could affect corneal sensitivity or normal spreading of the tear film (except superficial punctate keratitis), severe blepharitis or obvious inflammation of the eyelid margin, which in the judgment investigator may interfere with the interpretation of the study results; 3. Have any ocular injury to either eye in the 12 weeks prior to Visit 1; 4. Have undergone any ocular surgery (including intraocular surgery) within the past 6 months or has any ocular surgery planned over the course of their participation in the study; 5. Any prior history of laser refractive eye surgery; 6. Have a known allergy to, or previous reaction to, any eye drops required for the study; 7. Presence of significant corneal scarring or a physical factor that impairs the ability to perform corneal imaging; 8. Clinically significant dry eye disease, as specified in the TFOS DEWS II definition, defined by dry eye symptoms (i.e., an Ocular Surface Disease Index (OSDI) score greater than or equal to 13, out of 100 (Schiffman et al., 2000)) and one or more of the following clinical signs (Wolffsohn et al., 2017): a. Tear osmolarity of greater than or equal to 308 mOsm/L in either eye or interocular differences greater than 8mOsm/L; b. TBUT less than 10 sec in either eye; c. Ocular surface staining: greater than 5 corneal spots, greater than 9 conjunctival spots, or lid margin (greater than or equal to 2 mm length and greater than or equal to 25% width) 9. Current use of any topical medications other than artificial lubricant eye drops; 10. Women who are pregnant or breastfeeding at the time of study entry or who plan to become pregnant during the study (as reported by the participant); 11. Any vaccination within 1 week of Visit 1, by self-report; 12. Any upper respiratory viral infection within 2 weeks of Visit 1, by self-report; 13. Inability to sit/lie supine comfortably during the examination procedures; 14. Participation in an interventional clinical trial within the previous 30 days, or currently enrolled in an interventional clinical trial; 15. Current use of any eye drop or other therapy, or history of an intervention, that may make CL wear risky or challenging (e.g., use of glaucoma eye drop medications, filtering bleb, etc.); 16. A condition or situation that, in the opinion of the study investigator, will limit the potential participant’s ability to comply with the study protocol or might adversely affect their safety.
Outcome results
None listed