Trial Outcomes & Findings for Optive Brand For Day And Night Dry Eye Management (NCT NCT03208673)

Results Overview

A 12-question survey used to measure the symptoms of dry eye disease. Each of the 12 individual questions rate one symptom on a 0-4 scale, with 4 meaning that the symptom is present all of the time and 0 meaning the symptom is present none of the time. The overall ODSI score is calculated by adding all of the values from the 12 questions, multiplying that value by 25, and dividing the resulting value by the number of questions answered. This results in an overall scale that ranges from 0-100, with 100 being severe dry eye symptoms and 0 being no dry eye symptoms.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

35 participants

Primary outcome timeframe

Change from baseline to (day 30 +/- 3 days)

Results posted on

2019-06-20

Participant Flow

Participant milestones

Participant milestones
Measure	Optive® Fusion™ and Optive® Gel Drop A CE marked eyedrop, containing 0.1% sodium hyaluronate, 0.5% carmellose sodium and 0.9% glycerol for daytime use. The eyedrop will be used as needed up to four times a day but at least twice a day and A CE marked gel, containing 0.5% carboxymethylcellulose sodium and 0.9% glycerol for night time use. The eyedrop will be used once in the evening; the gel drop being instilled any time during the last hour prior to sleep.
Overall Study STARTED	32
Overall Study COMPLETED	32
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Data not collected for these data points.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Optive® Fusion™ and Optive® Gel Drop n=32 Participants A CE marked eyedrop, containing 0.1% sodium hyaluronate, 0.5% carmellose sodium and 0.9% glycerol for daytime use. The eyedrop will be used as needed up to four times a day but at least twice a day and A CE marked gel, containing 0.5% carboxymethylcellulose sodium and 0.9% glycerol for night time use. The eyedrop will be used once in the evening; the gel drop being instilled any time during the last hour prior to sleep.
Age, Continuous	52.13 Years n=32 Participants
Sex: Female, Male Female	23 Participants n=32 Participants
Sex: Female, Male Male	9 Participants n=32 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants Data not collected for these data points.
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants Data not collected for these data points.
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants Data not collected for these data points.

PRIMARY outcome

Timeframe: Change from baseline to (day 30 +/- 3 days)

A 12-question survey used to measure the symptoms of dry eye disease. Each of the 12 individual questions rate one symptom on a 0-4 scale, with 4 meaning that the symptom is present all of the time and 0 meaning the symptom is present none of the time. The overall ODSI score is calculated by adding all of the values from the 12 questions, multiplying that value by 25, and dividing the resulting value by the number of questions answered. This results in an overall scale that ranges from 0-100, with 100 being severe dry eye symptoms and 0 being no dry eye symptoms.

Outcome measures

Outcome measures
Measure	Optive® Fusion™ and Optive® Gel Drop n=32 Participants A CE marked eyedrop, containing 0.1% sodium hyaluronate, 0.5% carmellose sodium and 0.9% glycerol for daytime use. The eyedrop will be used as needed up to four times a day but at least twice a day and A CE marked gel, containing 0.5% carboxymethylcellulose sodium and 0.9% glycerol for night time use. The eyedrop will be used once in the evening; the gel drop being instilled any time during the last hour prior to sleep.
Change From Baseline in Ocular Surface Disease Index (OSDI) Total Score	-12.85 Scores on a scale Standard Deviation 14.80

PRIMARY outcome

Timeframe: Change from baseline to (day 30 +/- 3 days)

The Lissamine Green (LG) bulbar conjunctival staining was analysed post-hoc for both eyes. The photos were masked and for each image the Staining Area was measured (mm2).

Outcome measures

Outcome measures
Measure	Optive® Fusion™ and Optive® Gel Drop n=32 Participants A CE marked eyedrop, containing 0.1% sodium hyaluronate, 0.5% carmellose sodium and 0.9% glycerol for daytime use. The eyedrop will be used as needed up to four times a day but at least twice a day and A CE marked gel, containing 0.5% carboxymethylcellulose sodium and 0.9% glycerol for night time use. The eyedrop will be used once in the evening; the gel drop being instilled any time during the last hour prior to sleep.
Measured Lissamine Green Bulbar Conjunctival Staining (mm2) Nasal	0.03 mm2 Standard Deviation 0.04
Measured Lissamine Green Bulbar Conjunctival Staining (mm2) Temporal	0.03 mm2 Standard Deviation 0.08

SECONDARY outcome

Timeframe: Baseline (day 0) to (day 30 +/- 3 days)

The participant rated the severity of their symptomatology upon waking using a VAS scale. Participants put a mark on a 100 millimeter line where 0 (far left on the line) = no symptoms to 100 (far right on the line) = most severe symptoms.

Outcome measures

Outcome measures
Measure	Optive® Fusion™ and Optive® Gel Drop n=32 Participants A CE marked eyedrop, containing 0.1% sodium hyaluronate, 0.5% carmellose sodium and 0.9% glycerol for daytime use. The eyedrop will be used as needed up to four times a day but at least twice a day and A CE marked gel, containing 0.5% carboxymethylcellulose sodium and 0.9% glycerol for night time use. The eyedrop will be used once in the evening; the gel drop being instilled any time during the last hour prior to sleep.
Change From Baseline in Visual Analogue Scale (VAS): Symptomatology Upon Waking Comfort at Baseline	30.22 scores on a scale Standard Deviation 17.96
Change From Baseline in Visual Analogue Scale (VAS): Symptomatology Upon Waking Comfort at Day 30	58.02 scores on a scale Standard Deviation 29.56
Change From Baseline in Visual Analogue Scale (VAS): Symptomatology Upon Waking Dry at Baseline	59.08 scores on a scale Standard Deviation 27.34
Change From Baseline in Visual Analogue Scale (VAS): Symptomatology Upon Waking Dry at Day 30	42.28 scores on a scale Standard Deviation 32.74
Change From Baseline in Visual Analogue Scale (VAS): Symptomatology Upon Waking Gritty at Baseline	52.95 scores on a scale Standard Deviation 27.43
Change From Baseline in Visual Analogue Scale (VAS): Symptomatology Upon Waking Gritty at Day 30	31.09 scores on a scale Standard Deviation 31.81
Change From Baseline in Visual Analogue Scale (VAS): Symptomatology Upon Waking Vision at Baseline	49.00 scores on a scale Standard Deviation 30.91
Change From Baseline in Visual Analogue Scale (VAS): Symptomatology Upon Waking Vision at Day 30	64.84 scores on a scale Standard Deviation 29.98

Adverse Events

Optive® Fusion™ and Optive® Gel Drop

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Medical Director

Allergan

Phone: 714-246-4500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo. (Note that this agreement language may appear in the study protocol)
Publication restrictions are in place

Restriction type: OTHER