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| Name | Class |
|---|---|
| CooperVision, Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypo-osmolar drop 1 | Experimental | Subject will receive regular instillations of hypo-osmolar sterile saline drops with the lowest osmolarity of the two hypo-osmolar drops. |
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| Hypo-osmolar drop 2 | Experimental | Subject will receive regular instillations of hypo-osmolar sterile saline drops with the highest osmolarity of the two hypo-osmolar drops. |
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| Iso-osmolar drop | Experimental | Subject will receive regular instillations of sterile iso-osmolar saline drops. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypo-osmolar drop 1 | Device | 180 mOsmol sterile saline drops used as a contact lens rewetting drop. |
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| 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. |
| 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. |
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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:
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Contact Lens Research | Waterloo | Ontario | N2L 3G1 | Canada |
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| Hypo-osmolar drop 2 | Device | 240 mOsmol sterile saline drops used as a contact lens rewetting drop. |
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| Iso-osmolar drop | Device | 300 mOsmol sterile saline drops used as a contact lens rewetting drop. |
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| 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 |
| 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 |