The effect of Systane Complete and Systane Hydration on comfort, vision and satisfaction with mini-scleral contact lens wear

Phase 4

Completed

• Conditions: Contact lens comfort; Eye - Diseases / disorders of the eye

• Registration Number: ACTRN12619000274178
• Lead Sponsor: SW Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-25
• Study Completion: 2019-11-15
• Last Update Posted: 1 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Subjective comfort ratings will be collected using 0 to 100 visual analogue scales. The questionnaires will be administered on paper forms at the 1 hour and 6 hour post-lens insertion visits, and will be collected via text or online survey at 2 hours and 4 hours post-lens insertion.[Assessments will be conducted at 1 hour, 2 hours, 4 hours and 6 hours post-lens insertion. The primary timepoint is unknown and subject to investigation. However, appropriate statistical adjustments will be applied during the analysis to account for multiple comparisons.]

Secondary Outcome Measures

Name	Time	Method
Subjective vision ratings will be collected using 0 to 100 visual analogue scales. The questionnaires will be administered on paper forms at the 1 hour and 6 hour post-lens insertion visits, and will be collected via text or online survey at 2 hours and 4 hours post-lens insertion.[Assessments will be conducted at 1 hour, 2 hours, 4 hours and 6 hours post-lens insertion. ];Subjective satisfaction ratings will be collected using 0 to 100 visual analogue scales. The questionnaires will be administered on paper forms at the 1 hour and 6 hour post-lens insertion visits, and will be collected via text or online survey at 2 hours and 4 hours post-lens insertion.[Assessments will be conducted at 1 hour, 2 hours, 4 hours and 6 hours post-lens insertion. ]