Trial Outcomes & Findings for OPTI-FREE® PureMoist® for Presbyopic Contact Lens Wearers (NCT NCT02965820)

Last Updated: 2018-07-12

Results Overview

CLDEQ-8 score (assessment of contact lens discomfort) was obtained by adding the numerical responses to each of 8 items. Individual scales ranged from 0-4, 0-5, and 1-6, with a resultant overall score from 1 minimum to 37 maximum. A lower CLDEQ-8 score indicates less frequent or less intense symptoms.

Recruitment status

COMPLETED

Study phase

Target enrollment

122 participants

Primary outcome timeframe

Day 30, each product

Results posted on

2018-07-12

Participant Flow

Subjects were recruited from 8 study centers located in the United States.

Of the 122 enrolled, 1 subject was exited as a screen failure prior to randomization. This reporting group includes all randomized subjects (121).

Participant milestones

Participant milestones
Measure	OFPM/HMPS OPTI-FREE® PureMoist® (OFPM) multi-purpose contact lens solution in Period 1, followed by subject's habitual multi-purpose contact lens solution (HMPS) in Period 2. Each product used daily per packaging instructions with subject's habitual contact lenses for approximately 30 cleaning and disinfection cycles.	HMPS/OFPM Subject's habitual multi-purpose contact lens solution in Period1, followed by OPTI-FREE® PureMoist® contact lens solution in Period 2. Each product used daily per packaging instructions with subject's habitual contact lenses for approximately 30 cleaning and disinfection cycles.
Period 1, First 30 Days STARTED	59	62
Period 1, First 30 Days COMPLETED	59	62
Period 1, First 30 Days NOT COMPLETED	0	0
Period 2, Second 30 Days STARTED	58	62
Period 2, Second 30 Days COMPLETED	57	61
Period 2, Second 30 Days NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	OFPM/HMPS OPTI-FREE® PureMoist® (OFPM) multi-purpose contact lens solution in Period 1, followed by subject's habitual multi-purpose contact lens solution (HMPS) in Period 2. Each product used daily per packaging instructions with subject's habitual contact lenses for approximately 30 cleaning and disinfection cycles.	HMPS/OFPM Subject's habitual multi-purpose contact lens solution in Period1, followed by OPTI-FREE® PureMoist® contact lens solution in Period 2. Each product used daily per packaging instructions with subject's habitual contact lenses for approximately 30 cleaning and disinfection cycles.
Period 2, Second 30 Days Adverse Event	1	1

Baseline Characteristics

OPTI-FREE® PureMoist® for Presbyopic Contact Lens Wearers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall n=121 Participants OFPM and HMPS used during Period 1 and Period 2 in a crossover assignment.
Age, Continuous	52.7 years STANDARD_DEVIATION 5.32 • n=5 Participants
Sex: Female, Male Female	92 Participants n=5 Participants
Sex: Female, Male Male	29 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	119 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	20 Participants n=5 Participants
Race (NIH/OMB) White	101 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 30, each product

Population: Full Analysis Set with non-missing responses

Outcome measures

Outcome measures
Measure	OFPM n=120 Participants OPTI-FREE® PureMoist® multi-purpose contact lens solution used daily per packaging instructions with subject's habitual contact lenses for approximately 30 cleaning and disinfection cycles.	HMPS n=119 Participants Subject's habitual multi-purpose contact lens solution used daily per packaging instructions with subject's habitual contact lenses for approximately 30 cleaning and disinfection cycles.
Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Score at Day 30	13.4 units on a scale Standard Deviation 7.42	15.8 units on a scale Standard Deviation 7.87

Adverse Events

OFPM

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

HMPS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	OFPM n=121 participants at risk All subjects exposed to OPTI-FREE® PureMoist® multi-purpose contact lens solution	HMPS n=120 participants at risk All subjects exposed to habitual multi-purpose contact lens solution
Surgical and medical procedures Knee operation	0.83% 1/121 • Day 1 through study completion, an average of 60 days An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.	0.00% 0/120 • Day 1 through study completion, an average of 60 days An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.

Other adverse events

Adverse event data not reported

Additional Information

Head, CDMA Vision Care Franchise

Alcon, A Novartis Division

Phone: 1-888-451-3937

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
Publication restrictions are in place

Restriction type: OTHER