The Impact of Hypo-osmolar Drops on Contact Lens Comfort (SAFFRON)

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 Overview

• Status: Completed
• Conditions: Contact Lens Related Dry Eye
• Intervention / Treatment: Device: Hypo-osmolar drop 1; Device: Hypo-osmolar drop 2; Device: Iso-osmolar drop

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Waterloo, Ontario, Canada, N2L 3G1
      • Centre for Contact Lens Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hypo-osmolar drop 1; 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; 180 mOsmol sterile saline drops used as a contact lens rewetting drop.
Experimental: Hypo-osmolar drop 2; 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; 240 mOsmol sterile saline drops used as a contact lens rewetting drop.
Experimental: Iso-osmolar drop; Subject will receive regular instillations of sterile iso-osmolar saline drops.	Device: Iso-osmolar drop; 300 mOsmol sterile saline drops used as a contact lens rewetting drop.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre for Contact Lens Research
• Collaborators: Coopervision, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2017
• Primary Completion (Actual): March 28, 2017
• Study Completion (Actual): March 28, 2017

Study Registration Dates

• First Submitted: February 8, 2017
• First Submitted That Met QC Criteria: February 9, 2017
• First Posted (Actual): February 10, 2017

Study Record Updates

• Last Update Posted (Actual): May 4, 2017
• Last Update Submitted That Met QC Criteria: May 1, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Dry Eye Syndromes
• Other Study ID Numbers: 21907

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No