Trial Outcomes & Findings for Study of Two Marketed Ocular Anti-Allergy Medications in Subjects With Allergic Conjunctivitis (NCT NCT00534794)

Results Overview

Ocular itch was measured on a 0 (none) to 4 (severe itch with continual desire to rub eyes) scale. Negative values for change from baseline represent favorable outcomes.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

79 participants

Primary outcome timeframe

0 hours, 12 hours

Results posted on

2015-05-13

Participant Flow

Participant milestones

Participant milestones
Measure	Elestat 1 drop each eye for 2 days	Pataday 1 drop each eye for 1 day
Overall Study STARTED	40	39
Overall Study COMPLETED	40	39
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Two Marketed Ocular Anti-Allergy Medications in Subjects With Allergic Conjunctivitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Elestat n=40 Participants 1 drop each eye for 2 days	Pataday n=39 Participants 1 drop each eye for 1 day	Total n=79 Participants Total of all reporting groups
Age, Continuous	41.3 years STANDARD_DEVIATION 12.18 • n=5 Participants	40.1 years STANDARD_DEVIATION 13.41 • n=7 Participants	40.7 years STANDARD_DEVIATION 12.73 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	27 Participants n=7 Participants	47 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	12 Participants n=7 Participants	32 Participants n=5 Participants

PRIMARY outcome

Timeframe: 0 hours, 12 hours

Ocular itch was measured on a 0 (none) to 4 (severe itch with continual desire to rub eyes) scale. Negative values for change from baseline represent favorable outcomes.

Outcome measures

Outcome measures
Measure	Elestat n=40 Participants 1 drop each eye for 2 days	Pataday n=39 Participants 1 drop each eye for 1 day
Change in Ocular Itch Score From Baseline	-1.5 units on a scale Standard Deviation 1.36	-1.5 units on a scale Standard Deviation 1.07

SECONDARY outcome

Timeframe: 12 hours

Ocular comfort was measured on a 0 (more uncomfortable) to 10 (more comfortable) scale.

Outcome measures

Outcome measures
Measure	Elestat n=40 Participants 1 drop each eye for 2 days	Pataday n=39 Participants 1 drop each eye for 1 day
Ocular Comfort Score at 12 Hours	8.6 units on a scale Standard Deviation 1.62	8.5 units on a scale Standard Deviation 1.94

Adverse Events

Elestat

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Pataday

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

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee PI cannot publish or discuss trial results until written communication is received from Inspire.
Publication restrictions are in place

Restriction type: OTHER