Trial Outcomes & Findings for Clinical Assessment of a HYDRAGLYDE® Regimen (NCT NCT03026257)

Results Overview

The contact lens worn in the right eye was removed and stored dry and frozen until analysis. Total cholesterol uptake (cholesterol and cholesterol esters) was evaluated from a sample of the right contact lenses from each site and measured in micrograms. Lower total cholesterol uptake indicates increased lens performance.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

323 participants

Primary outcome timeframe

Day 30

Results posted on

2018-08-14

Participant Flow

Subjects were recruited from 8 study centers located in the United States (5), Germany (2), and Canada (1).

Of the 323 enrolled, 66 subjects exited as screen failures prior to randomization. An additional 5 subjects were randomized but discontinued prior to treatment. This reporting group includes all randomized and exposed subjects (252). Subject distribution in As Randomized and As Treatment differs due to 3 subjects with lens/solution misallocations.

Participant milestones

Participant milestones
Measure	AOHG/CCP Lotrafilcon B contact lenses with added wetting agent, worn bilaterally (in both eyes) for 30 days in a daily wear modality and cared for with a hydrogen peroxide-based contact lens solution with added wetting agent	AOHG/OFPM Lotrafilcon B contact lenses with added wetting agent, worn bilaterally for 30 days in a daily wear modality and cared for with a POLYQUAD/ALDOX-preserved contact lens solution with added wetting agent	Biofinity/HMPS Habitual silicone hydrogel (SiHy) contact lenses worn bilaterally for 30 days in a daily wear modality and cared for with participant's habitual multi-purpose solution (MPS)	Vita/HMPS Habitual SiHy contact lenses worn bilaterally for 30 days in a daily wear modality and cared for with participant's habitual MPS	Ultra/HMPS Habitual SiHy contact lenses worn bilaterally for 30 days in a daily wear modality and cared for with participant's habitual MPS	Oasys/HMPS Habitual SiHy contact lenses worn bilaterally for 30 days (replaced after 15 days) in a daily wear modality and cared for with participant's habitual MPS
Overall Study STARTED	60	64	34	25	23	46
Overall Study Treated	58	65	35	24	23	47
Overall Study COMPLETED	54	63	34	24	22	46
Overall Study NOT COMPLETED	6	1	0	1	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	AOHG/CCP Lotrafilcon B contact lenses with added wetting agent, worn bilaterally (in both eyes) for 30 days in a daily wear modality and cared for with a hydrogen peroxide-based contact lens solution with added wetting agent	AOHG/OFPM Lotrafilcon B contact lenses with added wetting agent, worn bilaterally for 30 days in a daily wear modality and cared for with a POLYQUAD/ALDOX-preserved contact lens solution with added wetting agent	Vita/HMPS Habitual SiHy contact lenses worn bilaterally for 30 days in a daily wear modality and cared for with participant's habitual MPS	Ultra/HMPS Habitual SiHy contact lenses worn bilaterally for 30 days in a daily wear modality and cared for with participant's habitual MPS
Overall Study Adverse Event	3	0	0	0
Overall Study Lost to Follow-up	1	0	0	0
Overall Study Protocol Violation	1	0	1	1
Overall Study Withdrawal by Subject	1	1	0	0

Baseline Characteristics

Clinical Assessment of a HYDRAGLYDE® Regimen

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AOHG/CCP n=60 Participants Lotrafilcon B contact lenses with added wetting agent, worn bilaterally for 30 days in a daily wear modality and cared for with a hydrogen peroxide-based contact lens solution with added wetting agent	AOHG/OFPM n=64 Participants Lotrafilcon B contact lenses with added wetting agent, worn bilaterally for 30 days in a daily wear modality and cared for with a POLYQUAD/ALDOX-preserved contact lens solution with added wetting agent	Biofinity/HMPS n=34 Participants Habitual SiHy contact lenses worn bilaterally for 30 days in a daily wear modality and cared for with participant's habitual MPS	Vita/HMPS n=25 Participants Habitual SiHy contact lenses worn bilaterally for 30 days in a daily wear modality and cared for with participant's habitual MPS	Ultra/HMPS n=23 Participants Habitual SiHy contact lenses worn bilaterally for 30 days in a daily wear modality and cared for with participant's habitual MPS	Oasys/HMPS n=46 Participants Habitual SiHy contact lenses worn bilaterally for 30 days (replaced after 15 days) in a daily wear modality and cared for with participant's habitual MPS	Total n=252 Participants Total of all reporting groups
Age, Continuous	27.7 years STANDARD_DEVIATION 7.0 • n=5 Participants	27.8 years STANDARD_DEVIATION 6.0 • n=7 Participants	28.2 years STANDARD_DEVIATION 5.9 • n=5 Participants	28.2 years STANDARD_DEVIATION 5.7 • n=4 Participants	28.8 years STANDARD_DEVIATION 7.2 • n=21 Participants	30.4 years STANDARD_DEVIATION 8.2 • n=8 Participants	28.4 years STANDARD_DEVIATION 6.8 • n=8 Participants
Sex: Female, Male Female	39 Participants n=5 Participants	49 Participants n=7 Participants	22 Participants n=5 Participants	17 Participants n=4 Participants	17 Participants n=21 Participants	35 Participants n=8 Participants	179 Participants n=8 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	15 Participants n=7 Participants	12 Participants n=5 Participants	8 Participants n=4 Participants	6 Participants n=21 Participants	11 Participants n=8 Participants	73 Participants n=8 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	3 Participants n=8 Participants	12 Participants n=8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	54 Participants n=5 Participants	62 Participants n=7 Participants	33 Participants n=5 Participants	24 Participants n=4 Participants	22 Participants n=21 Participants	43 Participants n=8 Participants	238 Participants n=8 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	2 Participants n=8 Participants

PRIMARY outcome

Timeframe: Day 30

Population: Full Analysis Set with cholesterol uptake measured

The contact lens worn in the right eye was removed and stored dry and frozen until analysis. Total cholesterol uptake (cholesterol and cholesterol esters) was evaluated from a sample of the right contact lenses from each site and measured in micrograms. Lower total cholesterol uptake indicates increased lens performance.