Trial Outcomes & Findings for The Retention Rate Between Brand A and Brand B Punctal Plugs (NCT NCT01947517)

NCT ID: NCT01947517

Last Updated: 2017-06-16

Results Overview

• Recruitment status: COMPLETED
• Target enrollment: 52 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2017-06-16

Participant Flow

Participant milestones

Measure	Parasol Group Randomized to receive Brand A punctal plugs Parasol Punctal Occluder	Superflex Group Randomized to receive Group B punctal plugs Superflex Punctal Occluder
Overall Study STARTED	26	26
Overall Study COMPLETED	25	25
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Measure	Parasol Group Randomized to receive Brand A punctal plugs Parasol Punctal Occluder	Superflex Group Randomized to receive Group B punctal plugs Superflex Punctal Occluder
Overall Study Withdrawal by Subject	1	1

Baseline Characteristics

The Retention Rate Between Brand A and Brand B Punctal Plugs

Baseline characteristics by cohort

Measure	Parasol Group n=25 Participants Randomized to receive Brand A punctal plugs Parasol Punctal Occluder	Superflex Group n=25 Participants Randomized to receive Group B punctal plugs Superflex Punctal Occluder	Total n=50 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	19 Participants n=5 Participants	20 Participants n=7 Participants	39 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Age, Continuous	61.7 years STANDARD_DEVIATION 17.67 • n=5 Participants	58.4 years STANDARD_DEVIATION 16.18 • n=7 Participants	60.1 years STANDARD_DEVIATION 15.97 • n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants	23 Participants n=7 Participants	45 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment Canada	25 participants n=5 Participants	25 participants n=7 Participants	50 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Outcome measures

Measure	Parasol Group n=25 Participants Randomized to receive Brand A punctal plugs Parasol Punctal Occluder	Superflex Group n=25 Participants Randomized to receive Group B punctal plugs Superflex Punctal Occluder
Length of Retention	6 months Standard Deviation 0	6 months Standard Deviation 0

SECONDARY outcome

Timeframe: 6 months

Describes the scores on a scale and range from 0-3. Higher score represents more severe dry eye. Score 0 = no dry eye symptoms, score 1 = mild dry eye symptoms, score 2 = moderate dry eye symptoms, score 3 = severe dry eye symptoms.

Outcome measures

Measure	Parasol Group n=25 Participants Randomized to receive Brand A punctal plugs Parasol Punctal Occluder	Superflex Group n=25 Participants Randomized to receive Group B punctal plugs Superflex Punctal Occluder
Canadian Dry Eye Assessment Score	1.06 scores on a scale Standard Deviation 1.081	0.25 scores on a scale Standard Deviation 1.018

SECONDARY outcome

Timeframe: 6 months

The cornea is divided into 5 zones, and the inferior zone 5 was assessed for staining pattern. Grade 0= no staining, grade 1= trace staining, grade 2= mild staining, grade 3= moderate staining, and grade 4= severe staining.

Outcome measures

Measure	Parasol Group n=25 Participants Randomized to receive Brand A punctal plugs Parasol Punctal Occluder	Superflex Group n=25 Participants Randomized to receive Group B punctal plugs Superflex Punctal Occluder
National Eye Institute Corneal Fluorescein Staining Pattern	3.28 Scores on a scale Standard Deviation 1.091	3.60 Scores on a scale Standard Deviation 0.756

SECONDARY outcome

Timeframe: 6 months

The conjunctival staining is divided into 6 zones. Each zone received a score for staining with lissamine green. Grade 0= no staining, grade 1= trace staining, grade 2= mild staining, grade 3= moderate staining, grade 4= severe staining. Data from different zones was combined and the total value was averaged.

Outcome measures

Measure	Parasol Group n=25 Participants Randomized to receive Brand A punctal plugs Parasol Punctal Occluder	Superflex Group n=25 Participants Randomized to receive Group B punctal plugs Superflex Punctal Occluder
National Eye Institute Grading for Conjunctival Staining	2.08 Scores on a scale Standard Deviation 0.895	2.08 Scores on a scale Standard Deviation 0.463

SECONDARY outcome

Timeframe: 6 months

Meniscus height measured in mm

Outcome measures

Measure	Parasol Group n=25 Participants Randomized to receive Brand A punctal plugs Parasol Punctal Occluder	Superflex Group n=25 Participants Randomized to receive Group B punctal plugs Superflex Punctal Occluder
Tear Meniscus Height	0.472 mm Standard Deviation 0.398	0.468 mm Standard Deviation 0.217

Adverse Events

Parasol Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Superflex Group

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

Dr. Stephanie Baxter

Queen's University

Phone: 613 544 3310

Email: baxters@baxtereyemd.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place