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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
20
180 mOsmol sterile saline drops used as a contact lens rewetting drop.
240 mOsmol sterile saline drops used as a contact lens rewetting drop.
300 mOsmol sterile saline drops used as a contact lens rewetting drop.
Centre for Contact Lens Research
Waterloo, Ontario, Canada
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: End of day 2, End of day 3
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, End of 1 day
Conjunctival hyperemia
Conjunctival hyperemia evaluated on a scale from 0 (negligible) to 100 (severe).
Time frame: Baseline, 4.5 hrs, End of 1 Day
Limbal hyperemia
Limbal hyperemia evaluated on a scale from 0 (normal) to 4 (severe).
Time frame: Baseline, 4.5 hrs, End of 1 Day
Average corneal staining
Average corneal staining evaluated on a scale from 0 (normal) to 4 (severe).
Time frame: Baseline, 4.5 hrs, End of 1 Day
Lens movement
Amount of lens movement on blink (mm).
Time frame: Baseline, 4.5 hrs, End of 1 Day
Lens lag
Amount of lens lag on blink (mm).
Time frame: Baseline, 4.5 hrs, End of 1 Day
Lens Tightness
Amount of lens tightness (%).
Time frame: Baseline, 4.5 hrs, End of 1 Day