None listed
Conditions
Brief summary
The purpose of this study is to compare subjective comfort, vision and satisfaction ratings, after insertion of mini-scleral (small diameter rigid gas permeable) contact lenses, when a drop of either ocular (eye) lubricant (i) Systane Complete containing HP-Guar and mineral oil (test eye drop #1) or (ii) Systane Hydration containing HP-Guar and sodium hyaluronate (test eye drop #2) is instilled prior to filling with unpreserved saline before inserting the lenses on eye, compared to filling with unpreserved saline alone (control eye drop), up to 6 hours after lens insertion. The hypothesis is that subjective ratings will be superior at any timepoint (2, 4 or 6 hours) post-lens insertion, when a drop of Systane Complete (test eye drop #1) and/or Systane Hydration (test eye drop #2) is instilled in mini-scleral contact lenses prior to filling with unpreserved saline, compared to filling with unpreserved saline (control) alone.
Interventions
The order of assignment to the test and control eye drops will be randomized, with a one week washout in between each study arm.
Arm 1: Systane Complete (HP-Guar and mineral oil) lubricant eye drop (test #1) - one drop (approx 40uL) will be instilled once only into the mini-scleral contact lens prior to lens insertion
Arm 2: Systane Hydration (HP Guar and sodium hyaluronate acid) lubricant eye drop (test #2) - one drop (approx 40uL) will be instilled once only into the mini-scleral contact lens
The order of assignment to the test and control eye drops will be randomized, with a one week washout in between each study arm. Arm 1: Systane Complete (HP-Guar and mineral oil) lubricant eye drop (test #1) - one drop (approx 40uL) will be instilled once only into the mini-scleral contact lens prior to lens insertion Arm 2: Systane Hydration (HP Guar and sodium hyaluronate acid) lubricant eye drop (test #2) - one drop (approx 40uL) will be instilled once only into the mini-scleral contact lens prior to lens insertion Arm 3: Unit dose saline (control) - approx 100uL will be instilled once only to fill the mini-scleral contact lens prior to lens insertion All of the study eye drops will be administered in-office by the unmasked study investigator.
Sponsors
UNSW Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent; Healthy experienced contact lens wearers aged 18 to 45 years of age (inclusive); Willing to refrain from using any eye drops and/or contact lenses 24 hours prior to each study visit; Spherical Refractive error between +6.00 and -8.00D (inclusive) with cylinder power less than or equal to 0.75D; Can attain good vision: Best corrected visual acuity of 6/9.5 or better in each eye; Willing to be fitted with and wear mini-scleral contact lenses for the duration of the study visits; Willing to attend the scheduled study visits and adhere to instructions.
Exclusion criteria
Patients who are currently using topical ocular medication or have used topical ocular medication within 2 weeks of the first visit. Patients who are being treated bilaterally with a marketed artificial tear for dry eye can be considered, provided they discontinue use for 24 hours prior to each visit; Any contraindications to safe contact lens wear; Any systemic disease that may affect ocular health e.g. Graves disease, and auto-immune diseases such as ankylosing spondylitis, multiple sclerosis and systemic lupus erythematosus; History of eye surgery within 6 months prior to enrolment in the study; Any known allergy to the ingredients in Systane Complete, Systane Hydration, saline and/or the lens disinfecting/conditioning solution.
Outcome results
None listed