Trial Outcomes & Findings for Efficacy Study of Ecabet Ophthalmic Solution in Dry Eye Disease (NCT NCT00667004)

Results Overview

The Schirmer's test is used determine if tear glands produce enough tears to keep eyes adequately moist. Calibrated strips of a non-toxic filter paper are used. One free end is placed within the lower eyelid. At the conclusion of the test, the paper strip is removed from the lower eyelid and the amount of wetting of the paper strip is measured.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

183 participants

Primary outcome timeframe

43 days

Results posted on

2020-09-03

Participant Flow

Participant milestones

Participant milestones
Measure	Ecabet Ophthalmic Solution ecabet ophthalmic solution ecabet ophthalmic solution: sterile ophthalmic solution	Vehicle Placebo comparator placebo: sterile ophthalmic solution
Overall Study STARTED	95	88
Overall Study COMPLETED	93	85
Overall Study NOT COMPLETED	2	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy Study of Ecabet Ophthalmic Solution in Dry Eye Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ecabet Ophthalmic Solution n=95 Participants ecabet ophthalmic solution ecabet ophthalmic solution: sterile ophthalmic solution	Vehicle n=88 Participants Placebo comparator placebo: sterile ophthalmic solution	Total n=183 Participants Total of all reporting groups
Age, Continuous	55.9 years STANDARD_DEVIATION 13.2 • n=5 Participants	56.0 years STANDARD_DEVIATION 15.2 • n=7 Participants	56.0 years STANDARD_DEVIATION 14.2 • n=5 Participants
Sex: Female, Male Female	76 Participants n=5 Participants	63 Participants n=7 Participants	139 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	25 Participants n=7 Participants	44 Participants n=5 Participants

PRIMARY outcome

Timeframe: 43 days

The Schirmer's test is used determine if tear glands produce enough tears to keep eyes adequately moist. Calibrated strips of a non-toxic filter paper are used. One free end is placed within the lower eyelid. At the conclusion of the test, the paper strip is removed from the lower eyelid and the amount of wetting of the paper strip is measured.

Outcome measures

Outcome measures
Measure	Ecabet Ophthalmic Solution n=95 Participants ecabet ophthalmic solution ecabet ophthalmic solution: sterile ophthalmic solution	Vehicle n=88 Participants Placebo comparator placebo: sterile ophthalmic solution
Mean Change From Baseline in Lacrimation Assessed by Schirmer's Test Anesthetized	3.02 mm Standard Deviation 4.70	2.15 mm Standard Deviation 4.40
Mean Change From Baseline in Lacrimation Assessed by Schirmer's Test Unanesthetized	2.35 mm Standard Deviation 5.53	1.35 mm Standard Deviation 5.38

Adverse Events

Ecabet Ophthalmic Solution

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Vehicle

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Ecabet Ophthalmic Solution n=95 participants at risk ecabet ophthalmic solution ecabet ophthalmic solution: sterile ophthalmic solution	Vehicle n=88 participants at risk Placebo comparator placebo: sterile ophthalmic solution
Musculoskeletal and connective tissue disorders Intervertebral disc degeneration	1.1% 1/95 • 43 days	0.00% 0/88 • 43 days
Musculoskeletal and connective tissue disorders Arthritis	1.1% 1/95 • 43 days	0.00% 0/88 • 43 days

Other adverse events

Adverse event data not reported

Additional Information

Study Director

Bausch Health

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Contact sponsor directly for details.
Publication restrictions are in place

Restriction type: OTHER