Ocular Comfort and the Aging Lens (ERBIUM)

Conditions

Refractive Error

Brief summary

The purpose of this trial was to evaluate the factors affecting comfortable contact lens wear and how those factors affect contact lens replacement frequency.

Detailed description

Eligible participants began Phase 1, following either Cycle A or Cycle B, and crossing over to the second cycle after completing the first. After the Phase 1 results were evaluated, eligible participants entered Phase 2. After Phase 2 results were evaluated, participants who consistently reported the highest and the lowest comfort scores entered Phase 3 and were defined as either survivors or strugglers.

Related papers

No related papers found yet.

Interventions

DEVICEHabitual contact lens

Hydrogel or silicone hydrogel contact lens per participant's habitual brand and prescription

DEVICELotrafilcon B contact lens

Commercially marketed silicone hydrogel contact lens

DEVICEContact lens cleaning and disinfecting system (ClearCare)

Commercially marketed, hydrogen peroxide-based contact lens care system

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

17 Years to No maximum

Healthy volunteers

No

Inclusion criteria

* At least 17 years of age. * Ocular exam in the last two years. * Currently wearing hydrogel or silicone hydrogel contact lenses on a daily wear basis with a monthly replacement schedule. * Wearing contact lenses at least five days per week for a minimum of 10 hours each day. * Able to wear lenses in the available power range with a best-corrected visual acuity of at least 20/32 in both eyes. * Other protocol-defined inclusion criteria may apply.

Exclusion criteria

* Any ocular disease. * Systemic condition that may affect a study outcome. * Using any systemic or topical medications that may affect ocular health. * Wears lenses on an extended or continuous wear schedule. * Habitually wears multifocal lenses. * Other protocol-defined

Design outcomes

Primary

Measure	Time frame	Description
Phase 3: Ocular Comfort, Lens Age 1 Day, Hour 1	Day 1	Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 1 day. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE (I CANNOT tolerate the comfort of my eyes! I am in pain!)and 100=VERY COMFORTABLE & FRESH (Wow! My eyes feel incredible! I love this feeling.)
Phase 3: Ocular Comfort, Lens Age 1 Day, Hour 10	Day 1	Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 1 day. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE (I CANNOT tolerate the comfort of my eyes! I am in pain!)and 100=VERY COMFORTABLE & FRESH (Wow! My eyes feel incredible! I love this feeling.)
Phase 3: Ocular Comfort, Lens Age 1 Day, End of Day	Day 1	Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 1 day. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE (I CANNOT tolerate the comfort of my eyes! I am in pain!)and 100=VERY COMFORTABLE & FRESH (Wow! My eyes feel incredible! I love this feeling.)
Phase 3: Ocular Comfort, Lens Age 14 Days, Hour 1	Day 15	Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 14 days. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE (I CANNOT tolerate the comfort of my eyes! I am in pain!)and 100=VERY COMFORTABLE & FRESH (Wow! My eyes feel incredible! I love this feeling.)
Phase 3: Ocular Comfort, Lens Age 14 Days, Hour 10	Day 15	Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 14 days. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE (I CANNOT tolerate the comfort of my eyes! I am in pain!)and 100=VERY COMFORTABLE & FRESH (Wow! My eyes feel incredible! I love this feeling.)
Phase 3: Ocular Comfort, Lens Age 14 Days, End of Day	Day 15	Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 14 days. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE (I CANNOT tolerate the comfort of my eyes! I am in pain!)and 100=VERY COMFORTABLE & FRESH (Wow! My eyes feel incredible! I love this feeling.)
Phase 3: Ocular Comfort, Lens Age 27 Days, Hour 1	Day 43	Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 27 days. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE (I CANNOT tolerate the comfort of my eyes! I am in pain!)and 100=VERY COMFORTABLE & FRESH (Wow! My eyes feel incredible! I love this feeling.)
Phase 3: Ocular Comfort, Lens Age 27 Days, Hour 10	Day 43	Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 27 days. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE (I CANNOT tolerate the comfort of my eyes! I am in pain!)and 100=VERY COMFORTABLE & FRESH (Wow! My eyes feel incredible! I love this feeling.)
Phase 3: Ocular Comfort, Lens Age 27 Days, End of Day	Day 43	Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 27 days. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE (I CANNOT tolerate the comfort of my eyes! I am in pain!)and 100=VERY COMFORTABLE & FRESH (Wow! My eyes feel incredible! I love this feeling.)

Countries

Canada

Participant flow

Recruitment details

Participants were recruited from one Canadian research center.

Pre-assignment details

Baseline characteristics are presented for all enrolled participants: 78. The participant flow chart includes all enrolled and dispensed participants: 72. Six participants were enrolled but not dispensed.

Participants by arm

Arm	Count
Overall This reporting group includes all enrolled and dispensed participants.	78
Total	78

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002
Phase 1: Period One, 30 Days of Wear	Asymptomatic infiltrates	1	0	0
Phase 1: Period One, 30 Days of Wear	Inconvenience	1	0	0
Phase 1: Period One, 30 Days of Wear	Unable to achieve acceptable comfort	0	1	0
Phase 1: Period Two, 30 Days of Wear	Inconvenience	0	1	0
Phase 2: 56 Days of Wear	Inconvenience	0	0	2
Phase 2: 56 Days of Wear	Relocation	0	0	2
Phase 2: 56 Days of Wear	Unable to achieve satisfactory comfort	0	0	1

Baseline characteristics

Characteristic	Overall
Age Continuous	25.7 years STANDARD_DEVIATION 7.9
Region of Enrollment Canada	78 participants
Sex: Female, Male Female	65 Participants
Sex: Female, Male Male	13 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 78	0 / 67
serious Total, serious adverse events	0 / 78	0 / 67

Outcome results

Primary

Phase 3: Ocular Comfort, Lens Age 14 Days, End of Day

Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 14 days. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE (I CANNOT tolerate the comfort of my eyes! I am in pain!)and 100=VERY COMFORTABLE & FRESH (Wow! My eyes feel incredible! I love this feeling.)

Time frame: Day 15