Trial Outcomes & Findings for SYSTANE® Family - Meibomian Deficiency (NCT NCT01733745)

Results Overview

Meibomian gland functionality was evaluated by the investigator using the Meibomian Gland Evaluator (MGE), a handheld instrument that provides a standardized method for applying consistent, gentle pressure to the outer skin of the lower eyelid. The total number of meibomian gland orificies evidencing liquid secretion during expression with the MGE, in both eyes, was recorded. A lower number of functioning meibomian glands may contribute to dry eye syndrome.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

26 participants

Primary outcome timeframe

Baseline, Month 1, Month 2, Month 3

Results posted on

2018-06-29

Participant Flow

Participants were recruited from 1 study center located in the US.

This reporting group includes all subjects who were enrolled and received at least one of the study treatments (26).

Participant milestones

Participant milestones
Measure	SYSTANE® Family SYSTANE® Lid Wipes administered to treated eye(s) once a day; SYSTANE® BALANCE lubricant eye drops administered to treated eye(s), 1 drop 4 times a day; SYSTANE® Vitamins, 2 softgels ingested daily. Duration of treatment was 3 months.	Standard of Care Microfiber towels (as warm compresses) warmed to the maximum comfortable temperature and placed over closed eyes for 8 minutes, 1 time a day. Duration of treatment was 3 months.
Overall Study STARTED	13	13
Overall Study COMPLETED	13	13
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

SYSTANE® Family - Meibomian Deficiency

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SYSTANE® Family n=13 Participants SYSTANE® Lid Wipes administered to treated eye(s) once a day; SYSTANE® BALANCE lubricant eye drops administered to treated eye(s), 1 drop 4 times a day; SYSTANE® Vitamins, 2 softgels ingested daily. Duration of treatment was 3 months.	Standard of Care n=13 Participants Microfiber towels (as warm compresses) warmed to the maximum comfortable temperature and placed over closed eyes for 8 minutes, 1 time a day. Duration of treatment was 3 months.	Total n=26 Participants Total of all reporting groups
Age, Continuous	38.1 years STANDARD_DEVIATION 19.9 • n=5 Participants	45.4 years STANDARD_DEVIATION 19.8 • n=7 Participants	41.7 years STANDARD_DEVIATION 19.8 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	10 Participants n=7 Participants	21 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Month 1, Month 2, Month 3

Population: This reporting group includes all subjects who were enrolled and received at least one of the study treatments.

Meibomian gland functionality was evaluated by the investigator using the Meibomian Gland Evaluator (MGE), a handheld instrument that provides a standardized method for applying consistent, gentle pressure to the outer skin of the lower eyelid. The total number of meibomian gland orificies evidencing liquid secretion during expression with the MGE, in both eyes, was recorded. A lower number of functioning meibomian glands may contribute to dry eye syndrome.

Outcome measures

Outcome measures
Measure	SYSTANE® Family n=13 Participants SYSTANE® Lid Wipes administered to treated eye(s) once a day; SYSTANE® BALANCE lubricant eye drops administered to treated eye(s), 1 drop 4 times a day; SYSTANE® Vitamins, 2 softgels ingested daily. Duration of treatment was 3 months.	Standard of Care n=13 Participants Microfiber towels (as warm compresses) warmed to the maximum comfortable temperature and placed over closed eyes for 8 minutes, 1 time a day. Duration of treatment was 3 months.
Number of Meibomian Glands Yielding Liquid Secretion (MGLYS) Baseline	3.5 functioning glands Standard Deviation 1.50	4.2 functioning glands Standard Deviation 1.39
Number of Meibomian Glands Yielding Liquid Secretion (MGLYS) Month 1	7.0 functioning glands Standard Deviation 3.12	3.9 functioning glands Standard Deviation 1.76
Number of Meibomian Glands Yielding Liquid Secretion (MGLYS) Month 2	6.4 functioning glands Standard Deviation 2.45	3.5 functioning glands Standard Deviation 1.90
Number of Meibomian Glands Yielding Liquid Secretion (MGLYS) Month 3	9.3 functioning glands Standard Deviation 2.72	4.7 functioning glands Standard Deviation 2.29

SECONDARY outcome

Timeframe: Baseline, Month 1, Month 2, Month 3

Population: This reporting group includes all subjects who were enrolled and received at least one of the study treatments.

The Standard Patient Evaluation of Eye Dryness (SPEED) Questionnaire is a 16-question validated questionnaire (resultant overall score 0-28, with 0 being best and 28 being worst) that measures the frequency and severity of dry eye symptoms. The SPEED questionnaire was completed by the patient with no assistance from the office staff, physician, or anyone else. Both eyes contributed to the mean.

Outcome measures

Outcome measures
Measure	SYSTANE® Family n=26 Eyes SYSTANE® Lid Wipes administered to treated eye(s) once a day; SYSTANE® BALANCE lubricant eye drops administered to treated eye(s), 1 drop 4 times a day; SYSTANE® Vitamins, 2 softgels ingested daily. Duration of treatment was 3 months.	Standard of Care n=26 Eyes Microfiber towels (as warm compresses) warmed to the maximum comfortable temperature and placed over closed eyes for 8 minutes, 1 time a day. Duration of treatment was 3 months.
Standard Patient Evaluation of Eye Dryness (SPEED) Questionnaire Responses Baseline	11.2 units on a scale Standard Deviation 2.59	11.2 units on a scale Standard Deviation 1.99
Standard Patient Evaluation of Eye Dryness (SPEED) Questionnaire Responses Month 1	8.2 units on a scale Standard Deviation 3.24	9.5 units on a scale Standard Deviation 3.91
Standard Patient Evaluation of Eye Dryness (SPEED) Questionnaire Responses Month 2	6.5 units on a scale Standard Deviation 3.02	7.9 units on a scale Standard Deviation 4.25
Standard Patient Evaluation of Eye Dryness (SPEED) Questionnaire Responses Month 3	5.0 units on a scale Standard Deviation 3.42	7.9 units on a scale Standard Deviation 4.46

SECONDARY outcome

Timeframe: Baseline, Month 1, Month 2, Month 3

Population: This reporting group includes all subjects who were enrolled and received at least one of the study treatments.

The Dry Eye OSDI Questionnaire is a 12-question validated questionnaire \[resultant overall 0-100 score, with 0 being none of the time (best) and 100 being all of the time (worst)\] that measures ocular symptoms, visual function, and environmental factors that may affect a patient's vision. The OSDI questionnaire was completed by the patient with no assistance from the office staff, physician, or anyone else. Both eyes contributed to the mean.

Outcome measures

Outcome measures
Measure	SYSTANE® Family n=26 Eyes SYSTANE® Lid Wipes administered to treated eye(s) once a day; SYSTANE® BALANCE lubricant eye drops administered to treated eye(s), 1 drop 4 times a day; SYSTANE® Vitamins, 2 softgels ingested daily. Duration of treatment was 3 months.	Standard of Care n=26 Eyes Microfiber towels (as warm compresses) warmed to the maximum comfortable temperature and placed over closed eyes for 8 minutes, 1 time a day. Duration of treatment was 3 months.
Dry Eye Ocular Surface Disease Index (OSDI) Questionnaire Responses Baseline	32.3 units on a scale Standard Deviation 12.82	26.9 units on a scale Standard Deviation 15.42
Dry Eye Ocular Surface Disease Index (OSDI) Questionnaire Responses Month 1	22.6 units on a scale Standard Deviation 10.48	21.0 units on a scale Standard Deviation 16.26
Dry Eye Ocular Surface Disease Index (OSDI) Questionnaire Responses Month 2	16.1 units on a scale Standard Deviation 9.57	19.7 units on a scale Standard Deviation 17.42
Dry Eye Ocular Surface Disease Index (OSDI) Questionnaire Responses Month 3	14.4 units on a scale Standard Deviation 10.20	17.9 units on a scale Standard Deviation 18.55

Adverse Events

SYSTANE® Family

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Standard of Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	SYSTANE® Family n=13 participants at risk SYSTANE® Lid Wipes administered to treated eye(s) once a day; SYSTANE® BALANCE lubricant eye drops administered to treated eye(s), 1 drop 4 times a day; SYSTANE® Vitamins, 2 softgels ingested daily. Duration of treatment was 3 months.	Standard of Care n=13 participants at risk Microfiber towels (as warm compresses) warmed to the maximum comfortable temperature and placed over closed eyes for 8 minutes, 1 time a day. Duration of treatment was 3 months.
Infections and infestations Infectious mononucleosis	7.7% 1/13 • Adverse events (AEs) were collected for the duration of the study (4 months). This analysis group includes all enrolled and exposed subjects. An AE is defined as any untoward medical occurrence in a subject who is administered a study treatment (i.e., initiation of treatment with test article) regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through volunteered and elicited comments by the participant.	0.00% 0/13 • Adverse events (AEs) were collected for the duration of the study (4 months). This analysis group includes all enrolled and exposed subjects. An AE is defined as any untoward medical occurrence in a subject who is administered a study treatment (i.e., initiation of treatment with test article) regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through volunteered and elicited comments by the participant.
Infections and infestations Sinusitis	7.7% 1/13 • Adverse events (AEs) were collected for the duration of the study (4 months). This analysis group includes all enrolled and exposed subjects. An AE is defined as any untoward medical occurrence in a subject who is administered a study treatment (i.e., initiation of treatment with test article) regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through volunteered and elicited comments by the participant.	0.00% 0/13 • Adverse events (AEs) were collected for the duration of the study (4 months). This analysis group includes all enrolled and exposed subjects. An AE is defined as any untoward medical occurrence in a subject who is administered a study treatment (i.e., initiation of treatment with test article) regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through volunteered and elicited comments by the participant.

Additional Information

Abayomi Ogundele, Pharm.D, Global Brand Medical Affairs Lead

Alcon Research, Ltd.

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