The Impact of Hypo-osmolar Drops on Contact Lens Comfort

Study Overview
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Brief Summary
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This pilot study will investigate the impact of sterile saline drops that are formulated at hypo-osmolar levels on CL comfort in comparison to an iso-osmolar drop, in a group of symptomatic CL wearers.

Official Title
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The Impact of Hypo-osmolar Drops on Contact Lens Comfort

Conditions
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Contact Lens Related Dry Eye

Intervention / Treatment
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* Device: Hypo-osmolar drop 1
* Device: Hypo-osmolar drop 2
* Device: Iso-osmolar drop


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Is at least 17 years of age; Has full legal capacity to volunteer; Has read and signed an information consent letter; Is willing and able to follow instructions and maintain the appointment schedule; Is willing and able to stay within the School of Optometry and Vision Science building for the duration of each Study Day; Currently wears daily, soft, frequent replacement lenses licensed in Canada (daily, bi-weekly or monthly disposable lenses, no extended wear, no monovision) for at least 3 days/week and 6 hours/day during the 2 months prior to enrolment; Is symptomatic according to the following classification: Reports a difference between average and comfortable wear time with habitual lenses of at least 3 hours; Fall into the symptomatic group as per Young's criteria (Appendix 4). Is able to remove and insert the lenses by themselves; Owns a wearable pair of spectacles; Is willing to wear the study lenses for 10 hours; Has visual acuity (VA) correctable to logMAR 0.20 or better in each eye; Shows an acceptable lens fit with their habitual lenses; Exclusion Criteria: Is participating in any concurrent clinical or research study; Has any known active* ocular disease and/ or infection; Has any ocular abnormality that would contraindicate contact lens wear; Has any known infection or inflammation that requires treatment or has a systemic condition that in the opinion of the investigator may affect the study measures; Is using any systemic or topical medications that in the option of the investigator may affect the study measures; Has any known sensitivity to the diagnostic pharmaceuticals and products to be used in this study; Is pregnant or lactating (by verbal communication) due to potential ocular physiology changes that may affect the study outcome; Is aphakic; Has undergone refractive error surgery; Is a member of the CCLR directly involved in the data collection. *For the purpose of this study, active ocular disease is defined as an infection or inflammation that requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered an active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.

Ages Eligible for Study
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Minimum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hypo-osmolar drop 1<br>Subject will receive regular instillations of hypo-osmolar sterile saline drops with the lowest osmolarity of the two hypo-osmolar drops. | Device: Hypo-osmolar drop 1<br>* 180 mOsmol sterile saline drops used as a contact lens rewetting drop.<br>|
| Experimental: Hypo-osmolar drop 2<br>Subject will receive regular instillations of hypo-osmolar sterile saline drops with the highest osmolarity of the two hypo-osmolar drops. | Device: Hypo-osmolar drop 2<br>* 240 mOsmol sterile saline drops used as a contact lens rewetting drop.<br>|
| Experimental: Iso-osmolar drop<br>Subject will receive regular instillations of sterile iso-osmolar saline drops. | Device: Iso-osmolar drop<br>* 300 mOsmol sterile saline drops used as a contact lens rewetting drop.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participant's Subjective Rating of Comfort (Questionnaire) | Participants rated their eye comfort by subjective questionnaire (un-annotated scale, 0-100, 0=Very poor comfort, 100=Excellent comfort). Change over time measured at baseline, 1.5 hrs, 3 hrs, 4.5 hrs, 6 hrs, 7.5 hrs, 9 hrs and End of day. | Baseline, 1.5hrs, 3hrs, 4.5hrs, 6hrs, 7.5hrs, 9hrs, End of 1 day | 
| Participant's Subjective Rating of Dryness (Questionnaire) | Participants rated the dryness of their eyes by subjective questionnaire (un-annotated scale, 0-100, 0=Very dry, 100=No dryness at all). Change over time measured at baseline, 1.5 hrs, 3 hrs, 4.5 hrs, 6 hrs, 7.5 hrs, 9 hrs and End of day. | Baseline, 1.5hrs, 3hrs, 4.5hrs, 6hrs, 7.5hrs, 9hrs, End of 1 day | 
| Participant's Subjective Rating of Foreign Body Sensation (Questionnaire) | Participants rated the foreign body sensation of their eyes by subjective questionnaire (un-annotated scale, 0-100, 0=Intense feeling of foreign body sensation, 100=No foreign body sensation at all). Change over time measured at baseline, 1.5 hrs, 3 hrs, 4.5 hrs, 6 hrs, 7.5 hrs, 9 hrs and End of day. | Baseline, 1.5hrs, 3hrs, 4.5hrs, 6hrs, 7.5hrs, 9hrs, End of 1 day | 
| Participant's Subjective Rating of Stability of Vision (Questionnaire) | Participants rated the stability of their vision by subjective questionnaire (un-annotated scale, 0-100, 0=Not stable at all/ very fluctuating, 100=Very stable). Change over time measured at baseline, 1.5 hrs, 3 hrs, 4.5 hrs, 6 hrs, 7.5 hrs, 9 hrs and End of day. | Baseline, 1.5hrs, 3hrs, 4.5hrs, 6hrs, 7.5hrs, 9hrs, End of 1 day | 
| Participant's Subjective Rating of Comfort (Questionnaire) - Likert scale | Participants responded to the statement My eyes feels comfortable (5 possible ratings, Strongly agree, agree, undecided, disagree, strongly disagree). Change over time measured at baseline, 1.5 hrs, 3 hrs, 4.5 hrs, 6 hrs, 7.5 hrs, 9 hrs and End of day. | Baseline, 1.5 hrs, 3 hrs, 4.5 hrs, 6 hrs, 7.5 hrs, 9 hrs and End of 1 day. | 
| Participant's Subjective Rating of Dryness (Questionnaire) - Likert scale | Participants responded to the statement My eyes feel dry (5 possible ratings, Strongly agree, agree, undecided, disagree, strongly disagree). Change over time measured at baseline, 1.5 hrs, 3 hrs, 4.5 hrs, 6 hrs, 7.5 hrs, 9 hrs and End of day. | Baseline, 1.5 hrs, 3 hrs, 4.5 hrs, 6 hrs, 7.5 hrs, 9 hrs and End of 1 day. | 
| Participant's Subjective Rating of Burning (Questionnaire) - Likert scale | Participants responded to the statement My eyes burn (5 possible ratings, Strongly agree, agree, undecided, disagree, strongly disagree). Change over time measured at baseline, 1.5 hrs, 3 hrs, 4.5 hrs, 6 hrs, 7.5 hrs, 9 hrs and End of day. | Baseline, 1.5 hrs, 3 hrs, 4.5 hrs, 6 hrs, 7.5 hrs, 9 hrs and End of 1 day. | 
| Participant's Subjective Rating of Awareness (Questionnaire) - Likert scale | Participants responded to the statement I am aware of the lenses in my eyes (5 possible ratings, Strongly agree, agree, undecided, disagree, strongly disagree). Change over time measured at baseline, 1.5 hrs, 3 hrs, 4.5 hrs, 6 hrs, 7.5 hrs, 9 hrs and End of day. | Baseline, 1.5 hrs, 3 hrs, 4.5 hrs, 6 hrs, 7.5 hrs, 9 hrs and End of 1 day. | 
| Participant's Subjective Rating of vision stability (Questionnaire) - Likert scale | Participants responded to the statement My vision is stable (5 possible ratings, Strongly agree, agree, undecided, disagree, strongly disagree). Change over time measured at baseline, 1.5 hrs, 3 hrs, 4.5 hrs, 6 hrs, 7.5 hrs, 9 hrs and End of day. | Baseline, 1.5 hrs, 3 hrs, 4.5 hrs, 6 hrs, 7.5 hrs, 9 hrs and End of 1 day. | 
| Drop preference (compared with last drop used) | Participant's subjective response for drop preference (compared with last drop used) at the end of days 2 and 3. (5 possible ratings: Strongly prefer Day 1, Prefer Day 1, No preference, Prefer Day 2, Strongly prefer day 2 OR Strongly Prefer Day 2, Prefer Day 2, No preference, Prefer Day 3, Strongly prefer day 3) | End of day 2, End of day 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tear film osmolarity | Tear film osmolarity in mOsmol/L, measured prior to the first drop of the day and at the end of the day. | Baseline, End of 1 day | 
| Tear meniscus height | Tear meniscus height in mm, measured prior to the first drop of the day and at the end of the day. | Baseline, End of 1 day | 
| Non-invasive tear film break-up time (NITBUT) | Measurement of time taken in seconds for a dry spot to appear on the corneal surface after blinking. | Baseline, End of 1 day | 
| Conjunctival hyperemia | Conjunctival hyperemia evaluated on a scale from 0 (negligible) to 100 (severe). | Baseline, 4.5 hrs, End of 1 Day | 
| Limbal hyperemia | Limbal hyperemia evaluated on a scale from 0 (normal) to 4 (severe). | Baseline, 4.5 hrs, End of 1 Day | 
| Average corneal staining | Average corneal staining evaluated on a scale from 0 (normal) to 4 (severe). | Baseline, 4.5 hrs, End of 1 Day | 
| Lens movement | Amount of lens movement on blink (mm). | Baseline, 4.5 hrs, End of 1 Day | 
| Lens lag | Amount of lens lag on blink (mm). | Baseline, 4.5 hrs, End of 1 Day | 
| Lens Tightness | Amount of lens tightness (%). | Baseline, 4.5 hrs, End of 1 Day |