Trial Outcomes & Findings for Clinical Outcomes Following Treatment With Systane® Balance in Dry Eye Subjects (NCT NCT01967147)

NCT ID: NCT01967147

Last Updated: 2016-03-23

Results Overview

TFBUT (the time required for dry spots to appear on the corneal surface after blinking) was assessed by the investigator using ophthalmic dye and a biomicroscope and measured in seconds. Subjects were dosed in the office 1 hour ±10 minutes prior to TFBUT assessment. A shorter TFBUT indicates a higher likelihood of dry eye symptoms. A positive change indicates an improvement in TFBUT. One eye (study eye) contributed to the analysis.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 279 participants
• Primary outcome timeframe: Baseline (Day 0), Day 35
• Results posted on: 2016-03-23

Participant Flow

Subjects were recruited from 14 study centers located in France, 4 study centers located in Germany, 3 study centers located in Spain, 3 study centers located in the Netherlands, 4 study centers located in the UK, 4 study centers located in Italy, and 3 study centers located in Poland.

Of the 279 subjects enrolled, 40 were exited as screen failures prior to randomization. An additional 25 were discontinued prior to randomization, following the outcome of the interim analysis. This reporting group includes all randomized subjects (214).

Participant milestones

Measure	Systane Balance Propylene Glycol, 1 drop in each eye, 4 times per day, during Phase I, followed by 1 drop in each eye as needed during Phase II	Saline Saline solution, 1 drop in each eye, 4 times/day, during Phase I, followed by 1 drop in each eye as needed during Phase II
Overall Study STARTED	112	102
Overall Study COMPLETED	99	82
Overall Study NOT COMPLETED	13	20

Reasons for withdrawal

Measure	Systane Balance Propylene Glycol, 1 drop in each eye, 4 times per day, during Phase I, followed by 1 drop in each eye as needed during Phase II	Saline Saline solution, 1 drop in each eye, 4 times/day, during Phase I, followed by 1 drop in each eye as needed during Phase II
Overall Study Adverse Event	5	2
Overall Study Lack of Efficacy	1	4
Overall Study Lost to Follow-up	1	2
Overall Study Withdrawal by Subject	2	4
Overall Study Non-compliance with Study Drug	0	3
Overall Study Other	4	5

Baseline Characteristics

Clinical Outcomes Following Treatment With Systane® Balance in Dry Eye Subjects

Baseline characteristics by cohort

Measure	Systane Balance n=112 Participants Propylene Glycol, 1 drop in each eye, 4 times per day, during Phase I, followed by 1 drop in each eye as needed during Phase II	Saline n=102 Participants Saline solution, 1 drop in each eye, 4 times/day, during Phase I, followed by 1 drop in each eye as needed during Phase II	Total n=214 Participants Total of all reporting groups
Age, Continuous	59.5 years STANDARD_DEVIATION 15.5 • n=5 Participants	58.4 years STANDARD_DEVIATION 14.0 • n=7 Participants	59.0 years STANDARD_DEVIATION 14.7 • n=5 Participants
Sex: Female, Male Female	91 Participants n=5 Participants	72 Participants n=7 Participants	163 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	30 Participants n=7 Participants	51 Participants n=5 Participants
Tear Film Break-up Time (TFBUT)	3.73 seconds STANDARD_DEVIATION 1.37 • n=5 Participants	3.71 seconds STANDARD_DEVIATION 1.59 • n=7 Participants	3.72 seconds STANDARD_DEVIATION 1.48 • n=5 Participants
Total Ocular Surface Staining (TOSS) Score	3.45 units on a scale STANDARD_DEVIATION 2.14 • n=5 Participants	3.35 units on a scale STANDARD_DEVIATION 2.38 • n=7 Participants	3.40 units on a scale STANDARD_DEVIATION 2.25 • n=5 Participants
Ocular surface disease index (OSDI)	40.24 units on a scale STANDARD_DEVIATION 17.48 • n=5 Participants	38.27 units on a scale STANDARD_DEVIATION 17.39 • n=7 Participants	39.30 units on a scale STANDARD_DEVIATION 17.42 • n=5 Participants
Impact of Dry Eye on Everyday Life (IDEEL) Treatment Effectiveness Score	44.63 units on a scale STANDARD_DEVIATION 27.32 • n=5 Participants	46.15 units on a scale STANDARD_DEVIATION 27.86 • n=7 Participants	45.35 units on a scale STANDARD_DEVIATION 27.52 • n=5 Participants
IDEEL Treatment Inconvenience	76.61 units on a scale STANDARD_DEVIATION 22.08 • n=5 Participants	74.48 units on a scale STANDARD_DEVIATION 24.85 • n=7 Participants	75.60 units on a scale STANDARD_DEVIATION 23.40 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline (Day 0), Day 35

Population: This analysis population includes all randomized subjects.

TFBUT (the time required for dry spots to appear on the corneal surface after blinking) was assessed by the investigator using ophthalmic dye and a biomicroscope and measured in seconds. Subjects were dosed in the office 1 hour ±10 minutes prior to TFBUT assessment. A shorter TFBUT indicates a higher likelihood of dry eye symptoms. A positive change indicates an improvement in TFBUT. One eye (study eye) contributed to the analysis.

Outcome measures

Measure	Systane Balance n=112 Participants Propylene Glycol, 1 drop in each eye, 4 times per day, during Phase I, followed by 1 drop in each eye as needed during Phase II	Saline n=102 Participants Saline solution, 1 drop in each eye, 4 times/day, during Phase I, followed by 1 drop in each eye as needed during Phase II
Change From Baseline in TFBUT at Day 35	1.5 seconds Standard Error 0.2	0.5 seconds Standard Error 0.2

SECONDARY outcome

Timeframe: Baseline (Day 0), Day 35

Population: This analysis population includes all randomized subjects.

The TOSS score (a cumulative cornea and conjunctival staining score) was assessed by the investigator using ophthalmic dye and a biomicroscope. Three areas of the ocular surface were graded for dryness on a 0-5 scale (0=Absent, 5=Severe), with a resultant overall score of 0-15. A negative change indicates an improvement in dry eye-related staining. One eye (study eye) contributed to the analysis.

Outcome measures

Measure	Systane Balance n=112 Participants Propylene Glycol, 1 drop in each eye, 4 times per day, during Phase I, followed by 1 drop in each eye as needed during Phase II	Saline n=102 Participants Saline solution, 1 drop in each eye, 4 times/day, during Phase I, followed by 1 drop in each eye as needed during Phase II
Change From Baseline in TOSS Score at Day 35	-0.81 units on a scale Standard Error 0.14	-0.64 units on a scale Standard Error 0.15

SECONDARY outcome

Timeframe: Baseline (Day 0), Day 35

Population: This analysis population includes all randomized subjects.

The OSDI is a 12-item quality of life questionnaire designed to assess ocular surface symptoms, their severity, and their impact on the subject's ability to function. Each item was scored by the subject on a 0-4 Likert-type scale (0=None, 4=All of the Time), with a resultant overall score of 0-100 (0=no disability, 100=complete disability). A negative change number represents a perceived improvement in ocular health.

Outcome measures

Measure	Systane Balance n=112 Participants Propylene Glycol, 1 drop in each eye, 4 times per day, during Phase I, followed by 1 drop in each eye as needed during Phase II	Saline n=102 Participants Saline solution, 1 drop in each eye, 4 times/day, during Phase I, followed by 1 drop in each eye as needed during Phase II
Change From Baseline in OSDI Score at Day 35	-13.7 units on a scale Standard Error 1.44	-8.38 units on a scale Standard Error 1.56

SECONDARY outcome

Timeframe: Baseline (Day 0), Day 35

Population: This analysis population includes all randomized subjects.

The IDEEL is a 10-item questionnaire designed to assess the subject's general satisfaction with treatment use. The subject responded to treatment effectiveness questions (Questions 2-5) using a 0-4 Likert-type scale, where 0=None of the time and 4=All of the time. The IDEEL treatment effectiveness score was calculated as the sum of the responses from Questions 2-5 divided by the number of questions (2-5) answered, multiplied by 25, for a resultant overall score of 0-100. A positive change number represents perceived improvement.

Outcome measures

Measure	Systane Balance n=112 Participants Propylene Glycol, 1 drop in each eye, 4 times per day, during Phase I, followed by 1 drop in each eye as needed during Phase II	Saline n=102 Participants Saline solution, 1 drop in each eye, 4 times/day, during Phase I, followed by 1 drop in each eye as needed during Phase II
Change From Baseline in IDEEL Treatment Effectiveness Score at Day 35	21.51 units on a scale Standard Error 2.43	5.50 units on a scale Standard Error 2.65

SECONDARY outcome

Timeframe: Baseline (Day 0), Day 35

Population: This analysis population includes all randomized subjects.

The IDEEL is a 10-item questionnaire designed to assess the subject's general satisfaction with treatment use. The subject responded to treatment inconvenience questions (Questions 6, 8-10) using a 0-4 Likert-type scale, where 0=All of the time and 4=None of the time. The IDEEL treatment inconvenience score was calculated as the sum of the responses from Questions 6, 8-10 divided by the number of questions (6, 8-10) answered, multiplied by 25, for a resultant overall score of 0-100. A positive change number represents perceived improvement.

Outcome measures

Measure	Systane Balance n=112 Participants Propylene Glycol, 1 drop in each eye, 4 times per day, during Phase I, followed by 1 drop in each eye as needed during Phase II	Saline n=102 Participants Saline solution, 1 drop in each eye, 4 times/day, during Phase I, followed by 1 drop in each eye as needed during Phase II
Change From Baseline in IDEEL Treatment Inconvenience Score at Day 35	1.30 units on a scale Standard Error 1.56	0.77 units on a scale Standard Error 1.70

Adverse Events

Pretreatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Systane Balance

Serious events: 2 serious events

Other events: 6 other events

Deaths: 0 deaths

Saline

Serious events: 2 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Pretreatment n=279 participants at risk All subjects prior to exposure to investigational product	Systane Balance n=110 participants at risk All subjects exposed to Systane® Balance	Saline n=100 participants at risk All subjects exposed to Saline
Injury, poisoning and procedural complications Femur fracture	0.00% 0/279 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 90 days). AEs were reported as pretreatment and treatment-emergent. Ocular adverse events are presented for both study eye and non-study eye. An AE was defined as any untoward medical occurrence, unintended injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the medical device/product. AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the Investigator, as outlined in the protocol.	0.00% 0/110 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 90 days). AEs were reported as pretreatment and treatment-emergent. Ocular adverse events are presented for both study eye and non-study eye. An AE was defined as any untoward medical occurrence, unintended injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the medical device/product. AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the Investigator, as outlined in the protocol.	1.0% 1/100 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 90 days). AEs were reported as pretreatment and treatment-emergent. Ocular adverse events are presented for both study eye and non-study eye. An AE was defined as any untoward medical occurrence, unintended injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the medical device/product. AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the Investigator, as outlined in the protocol.
Injury, poisoning and procedural complications Multiple fractures	0.00% 0/279 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 90 days). AEs were reported as pretreatment and treatment-emergent. Ocular adverse events are presented for both study eye and non-study eye. An AE was defined as any untoward medical occurrence, unintended injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the medical device/product. AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the Investigator, as outlined in the protocol.	0.91% 1/110 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 90 days). AEs were reported as pretreatment and treatment-emergent. Ocular adverse events are presented for both study eye and non-study eye. An AE was defined as any untoward medical occurrence, unintended injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the medical device/product. AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the Investigator, as outlined in the protocol.	0.00% 0/100 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 90 days). AEs were reported as pretreatment and treatment-emergent. Ocular adverse events are presented for both study eye and non-study eye. An AE was defined as any untoward medical occurrence, unintended injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the medical device/product. AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the Investigator, as outlined in the protocol.
Surgical and medical procedures Renal cyst excision	0.00% 0/279 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 90 days). AEs were reported as pretreatment and treatment-emergent. Ocular adverse events are presented for both study eye and non-study eye. An AE was defined as any untoward medical occurrence, unintended injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the medical device/product. AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the Investigator, as outlined in the protocol.	0.00% 0/110 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 90 days). AEs were reported as pretreatment and treatment-emergent. Ocular adverse events are presented for both study eye and non-study eye. An AE was defined as any untoward medical occurrence, unintended injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the medical device/product. AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the Investigator, as outlined in the protocol.	1.0% 1/100 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 90 days). AEs were reported as pretreatment and treatment-emergent. Ocular adverse events are presented for both study eye and non-study eye. An AE was defined as any untoward medical occurrence, unintended injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the medical device/product. AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the Investigator, as outlined in the protocol.
Surgical and medical procedures Laryngeal operation	0.00% 0/279 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 90 days). AEs were reported as pretreatment and treatment-emergent. Ocular adverse events are presented for both study eye and non-study eye. An AE was defined as any untoward medical occurrence, unintended injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the medical device/product. AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the Investigator, as outlined in the protocol.	0.91% 1/110 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 90 days). AEs were reported as pretreatment and treatment-emergent. Ocular adverse events are presented for both study eye and non-study eye. An AE was defined as any untoward medical occurrence, unintended injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the medical device/product. AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the Investigator, as outlined in the protocol.	0.00% 0/100 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 90 days). AEs were reported as pretreatment and treatment-emergent. Ocular adverse events are presented for both study eye and non-study eye. An AE was defined as any untoward medical occurrence, unintended injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the medical device/product. AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the Investigator, as outlined in the protocol.
Vascular disorders Arterial haemorrhage	0.00% 0/279 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 90 days). AEs were reported as pretreatment and treatment-emergent. Ocular adverse events are presented for both study eye and non-study eye. An AE was defined as any untoward medical occurrence, unintended injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the medical device/product. AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the Investigator, as outlined in the protocol.	0.00% 0/110 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 90 days). AEs were reported as pretreatment and treatment-emergent. Ocular adverse events are presented for both study eye and non-study eye. An AE was defined as any untoward medical occurrence, unintended injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the medical device/product. AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the Investigator, as outlined in the protocol.	1.0% 1/100 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 90 days). AEs were reported as pretreatment and treatment-emergent. Ocular adverse events are presented for both study eye and non-study eye. An AE was defined as any untoward medical occurrence, unintended injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the medical device/product. AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the Investigator, as outlined in the protocol.

Other adverse events

Measure	Pretreatment n=279 participants at risk All subjects prior to exposure to investigational product	Systane Balance n=110 participants at risk All subjects exposed to Systane® Balance	Saline n=100 participants at risk All subjects exposed to Saline
Eye disorders Eye irritation	0.00% 0/279 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 90 days). AEs were reported as pretreatment and treatment-emergent. Ocular adverse events are presented for both study eye and non-study eye. An AE was defined as any untoward medical occurrence, unintended injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the medical device/product. AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the Investigator, as outlined in the protocol.	5.5% 6/110 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 90 days). AEs were reported as pretreatment and treatment-emergent. Ocular adverse events are presented for both study eye and non-study eye. An AE was defined as any untoward medical occurrence, unintended injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the medical device/product. AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the Investigator, as outlined in the protocol.	1.0% 1/100 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 90 days). AEs were reported as pretreatment and treatment-emergent. Ocular adverse events are presented for both study eye and non-study eye. An AE was defined as any untoward medical occurrence, unintended injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the medical device/product. AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the Investigator, as outlined in the protocol.

Additional Information

Global Brand Med Affairs Lead, GCRA, GMA Pharma

Alcon Research, Ltd.

Phone: 1-888-451-3937

Email: alcon.medinfo@alcon.com

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