Trial Outcomes & Findings for Safety and Efficacy of Punctal Plug Insertion in Patients With Dry Eye (NCT NCT01684436)
NCT ID: NCT01684436
Last Updated: 2019-04-17
Results Overview
A punctal plug (tear duct plug) is a device inserted into the tear duct (puncta) of the eye to block the tear duct from draining liquid from the eye. Tears were collected using the Schirmer's test strip. Tears are measured in the study eye for tear cytokine levels before punctal plug insertion in picogram(pg)/milliliter (mL)/millimeter (mm) of Schirmer's test strip moistened. Cytokines help with the generation of an immune response. Increased cytokine levels are representative of inflammation in the eye.
COMPLETED
PHASE4
30 participants
Week 0 (Baseline)
2019-04-17
Participant Flow
Participant milestones
| Measure |
Punctal Plug
Punctal plugs inserted into the study eye on Day 1.
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
29
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy of Punctal Plug Insertion in Patients With Dry Eye
Baseline characteristics by cohort
| Measure |
Punctal Plug
n=29 Participants
Punctal plugs inserted into the study eye on Day 1.
|
|---|---|
|
Age, Continuous
|
49.8 Years
STANDARD_DEVIATION 14.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 0 (Baseline)Population: All patients who completed the study
A punctal plug (tear duct plug) is a device inserted into the tear duct (puncta) of the eye to block the tear duct from draining liquid from the eye. Tears were collected using the Schirmer's test strip. Tears are measured in the study eye for tear cytokine levels before punctal plug insertion in picogram(pg)/milliliter (mL)/millimeter (mm) of Schirmer's test strip moistened. Cytokines help with the generation of an immune response. Increased cytokine levels are representative of inflammation in the eye.
Outcome measures
| Measure |
Punctal Plug
n=29 Participants
Punctal plugs inserted into the study eye on Day 1.
|
|---|---|
|
Concentration of Tear Cytokine Levels Before Punctal Plug Insertion in the Study Eye
Interferon (IFN)
|
2.24 picogram/milliliter/millimeter(pg/ml/mm)
Standard Deviation 2.02
|
|
Concentration of Tear Cytokine Levels Before Punctal Plug Insertion in the Study Eye
Interleukin-10 (IL10)
|
4.69 picogram/milliliter/millimeter(pg/ml/mm)
Standard Deviation 3.54
|
|
Concentration of Tear Cytokine Levels Before Punctal Plug Insertion in the Study Eye
Interleukin-1B (IL1B)
|
0.63 picogram/milliliter/millimeter(pg/ml/mm)
Standard Deviation 0.37
|
|
Concentration of Tear Cytokine Levels Before Punctal Plug Insertion in the Study Eye
Interleukin-12 (IL12)
|
9.08 picogram/milliliter/millimeter(pg/ml/mm)
Standard Deviation 9.98
|
|
Concentration of Tear Cytokine Levels Before Punctal Plug Insertion in the Study Eye
Interleukin-13 (IL13)
|
29.81 picogram/milliliter/millimeter(pg/ml/mm)
Standard Deviation 26.53
|
|
Concentration of Tear Cytokine Levels Before Punctal Plug Insertion in the Study Eye
Interleukin-17A (IL17A)
|
0.57 picogram/milliliter/millimeter(pg/ml/mm)
Standard Deviation 0.48
|
|
Concentration of Tear Cytokine Levels Before Punctal Plug Insertion in the Study Eye
Matrix metallopeptidase 9 (MMP9)
|
1519.82 picogram/milliliter/millimeter(pg/ml/mm)
Standard Deviation 1516.92
|
|
Concentration of Tear Cytokine Levels Before Punctal Plug Insertion in the Study Eye
Interleukin-2 (IL2)
|
0.88 picogram/milliliter/millimeter(pg/ml/mm)
Standard Deviation 0.59
|
|
Concentration of Tear Cytokine Levels Before Punctal Plug Insertion in the Study Eye
Interleukin-4 (IL4)
|
17.66 picogram/milliliter/millimeter(pg/ml/mm)
Standard Deviation 21.59
|
|
Concentration of Tear Cytokine Levels Before Punctal Plug Insertion in the Study Eye
Interleukin-6 (IL6)
|
6.11 picogram/milliliter/millimeter(pg/ml/mm)
Standard Deviation 6.73
|
|
Concentration of Tear Cytokine Levels Before Punctal Plug Insertion in the Study Eye
Interleukin-8 (IL8)
|
74.00 picogram/milliliter/millimeter(pg/ml/mm)
Standard Deviation 55.03
|
|
Concentration of Tear Cytokine Levels Before Punctal Plug Insertion in the Study Eye
Interferon γ-Induced Protein-10 (IP10)
|
2384.86 picogram/milliliter/millimeter(pg/ml/mm)
Standard Deviation 1198.08
|
|
Concentration of Tear Cytokine Levels Before Punctal Plug Insertion in the Study Eye
Monocyte Chemotactic Protein 1 (MCP1)
|
49.08 picogram/milliliter/millimeter(pg/ml/mm)
Standard Deviation 46.91
|
|
Concentration of Tear Cytokine Levels Before Punctal Plug Insertion in the Study Eye
Macrophage Inflammatory Protein 1 Alpha (MIP1A)
|
0.59 picogram/milliliter/millimeter(pg/ml/mm)
Standard Deviation 0.56
|
|
Concentration of Tear Cytokine Levels Before Punctal Plug Insertion in the Study Eye
Regulate Activation Normal T-Cell Express (RANTE)
|
21.20 picogram/milliliter/millimeter(pg/ml/mm)
Standard Deviation 15.57
|
|
Concentration of Tear Cytokine Levels Before Punctal Plug Insertion in the Study Eye
Tumor Necrosis Factor Alpha (TNFA)
|
1.54 picogram/milliliter/millimeter(pg/ml/mm)
Standard Deviation 1.46
|
PRIMARY outcome
Timeframe: Week 3Population: All patients who completed the study
A punctal plug (tear duct plug) is a device inserted into the tear duct (puncta) of the eye to block the tear duct from draining liquid from the eye. Tears were collected using the Schirmer's test strip. Tears are measured in the study eye for tear cytokine levels before punctal plug insertion in picogram(pg)/milliliter (mL)/millimeter (mm) of Schirmer's test strip moistened. Cytokines help with the generation of an immune response. Increased cytokine levels are representative of inflammation in the eye.
Outcome measures
| Measure |
Punctal Plug
n=29 Participants
Punctal plugs inserted into the study eye on Day 1.
|
|---|---|
|
Concentration of Tear Cytokine Levels Following Punctal Plug Insertion in the Study Eye
IL10
|
3.97 picogram/milliliter/millimeter(pg/ml/mm)
Standard Deviation 3.35
|
|
Concentration of Tear Cytokine Levels Following Punctal Plug Insertion in the Study Eye
IL13
|
29.14 picogram/milliliter/millimeter(pg/ml/mm)
Standard Deviation 23.35
|
|
Concentration of Tear Cytokine Levels Following Punctal Plug Insertion in the Study Eye
IL17A
|
0.55 picogram/milliliter/millimeter(pg/ml/mm)
Standard Deviation 0.39
|
|
Concentration of Tear Cytokine Levels Following Punctal Plug Insertion in the Study Eye
IFN
|
3.12 picogram/milliliter/millimeter(pg/ml/mm)
Standard Deviation 2.69
|
|
Concentration of Tear Cytokine Levels Following Punctal Plug Insertion in the Study Eye
IL12
|
7.34 picogram/milliliter/millimeter(pg/ml/mm)
Standard Deviation 6.05
|
|
Concentration of Tear Cytokine Levels Following Punctal Plug Insertion in the Study Eye
IL1B
|
1.10 picogram/milliliter/millimeter(pg/ml/mm)
Standard Deviation 1.03
|
|
Concentration of Tear Cytokine Levels Following Punctal Plug Insertion in the Study Eye
MMP9
|
1445.53 picogram/milliliter/millimeter(pg/ml/mm)
Standard Deviation 1415.09
|
|
Concentration of Tear Cytokine Levels Following Punctal Plug Insertion in the Study Eye
IL2
|
1.05 picogram/milliliter/millimeter(pg/ml/mm)
Standard Deviation 1.10
|
|
Concentration of Tear Cytokine Levels Following Punctal Plug Insertion in the Study Eye
IL4
|
9.75 picogram/milliliter/millimeter(pg/ml/mm)
Standard Deviation 8.31
|
|
Concentration of Tear Cytokine Levels Following Punctal Plug Insertion in the Study Eye
IL6
|
4.31 picogram/milliliter/millimeter(pg/ml/mm)
Standard Deviation 3.66
|
|
Concentration of Tear Cytokine Levels Following Punctal Plug Insertion in the Study Eye
IL8
|
61.07 picogram/milliliter/millimeter(pg/ml/mm)
Standard Deviation 57.15
|
|
Concentration of Tear Cytokine Levels Following Punctal Plug Insertion in the Study Eye
IP10
|
2769.17 picogram/milliliter/millimeter(pg/ml/mm)
Standard Deviation 1479.50
|
|
Concentration of Tear Cytokine Levels Following Punctal Plug Insertion in the Study Eye
MCP1
|
68.08 picogram/milliliter/millimeter(pg/ml/mm)
Standard Deviation 62.10
|
|
Concentration of Tear Cytokine Levels Following Punctal Plug Insertion in the Study Eye
MIP1A
|
0.61 picogram/milliliter/millimeter(pg/ml/mm)
Standard Deviation 0.73
|
|
Concentration of Tear Cytokine Levels Following Punctal Plug Insertion in the Study Eye
RANTE
|
29.55 picogram/milliliter/millimeter(pg/ml/mm)
Standard Deviation 26.99
|
|
Concentration of Tear Cytokine Levels Following Punctal Plug Insertion in the Study Eye
TNFA
|
1.37 picogram/milliliter/millimeter(pg/ml/mm)
Standard Deviation 1.21
|
SECONDARY outcome
Timeframe: Week 0 (Baseline), Week 3Population: All patients who completed the study
The cornea is evaluated following ocular administration of fluorescein stain in the study eye. The cornea is the transparent front part of the eye which covers the iris and pupil. The cornea is divided into 5 regions. Each region is scored according to the extent of staining, with scores ranging from 0 to 4 points: 0=non-staining to 4=regional whole staining of the cornea with 0.5 unit intervals. The higher the staining score, the worse the dry eye condition.
Outcome measures
| Measure |
Punctal Plug
n=29 Participants
Punctal plugs inserted into the study eye on Day 1.
|
|---|---|
|
Corneal Fluorescein Staining Score in the Study Eye
Week 3: Inferior
|
1.22 Scores on a Scale
Standard Deviation 0.85
|
|
Corneal Fluorescein Staining Score in the Study Eye
Week 3: Nasal
|
0.41 Scores on a Scale
Standard Deviation 0.84
|
|
Corneal Fluorescein Staining Score in the Study Eye
Week 0 (Baseline): Superior
|
0.57 Scores on a Scale
Standard Deviation 0.85
|
|
Corneal Fluorescein Staining Score in the Study Eye
Week 0 (Baseline): Inferior
|
1.33 Scores on a Scale
Standard Deviation 0.93
|
|
Corneal Fluorescein Staining Score in the Study Eye
Week 0 (Baseline): Nasal
|
0.67 Scores on a Scale
Standard Deviation 0.89
|
|
Corneal Fluorescein Staining Score in the Study Eye
Week 0 (Baseline): Temporal
|
0.72 Scores on a Scale
Standard Deviation 0.96
|
|
Corneal Fluorescein Staining Score in the Study Eye
Week 0 (Baseline): Central
|
0.91 Scores on a Scale
Standard Deviation 0.95
|
|
Corneal Fluorescein Staining Score in the Study Eye
Week 3: Superior
|
0.48 Scores on a Scale
Standard Deviation 0.62
|
|
Corneal Fluorescein Staining Score in the Study Eye
Week 3: Temporal
|
0.36 Scores on a Scale
Standard Deviation 0.74
|
|
Corneal Fluorescein Staining Score in the Study Eye
Week 3: Central
|
0.57 Scores on a Scale
Standard Deviation 0.73
|
SECONDARY outcome
Timeframe: Week 0 (Baseline), Week 3Population: All patients who completed the study
TBUT is defined as the time to initial breakup of the tear film following a blink. The longer it takes, the more stable the tear film.
Outcome measures
| Measure |
Punctal Plug
n=29 Participants
Punctal plugs inserted into the study eye on Day 1.
|
|---|---|
|
Tear Film Break-up Time (TBUT)
Week 0 (Baseline)
|
2.21 Seconds
Standard Deviation 0.57
|
|
Tear Film Break-up Time (TBUT)
Week 3
|
2.42 Seconds
Standard Deviation 0.76
|
SECONDARY outcome
Timeframe: Week 0 (Baseline), Week 3Population: All patients who completed the study
The Schirmer's Test measures the rate of tear secretion by the eye over 5 minutes (min). The results indicate the presence of dry eye (Normal = greater than or equal to 10 millimeters (mm) of tears, Dry Eye = less than 10 mm of tears). The smaller the number, the more severe the dry eye.
Outcome measures
| Measure |
Punctal Plug
n=29 Participants
Punctal plugs inserted into the study eye on Day 1.
|
|---|---|
|
Schirmer's Test Score
Week 0 (Baseline)
|
5.07 Millimeters (mm)
Standard Deviation 2.76
|
|
Schirmer's Test Score
Week 3
|
6.28 Millimeters (mm)
Standard Deviation 5.11
|
SECONDARY outcome
Timeframe: Week 0 (Baseline), Week 3Population: All patients who completed the study
Severity of dry eye irritation is rated by the patient using a visual analogue scale (VAS). Patients 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. The higher the score, the more severe the symptoms.
Outcome measures
| Measure |
Punctal Plug
n=29 Participants
Punctal plugs inserted into the study eye on Day 1.
|
|---|---|
|
Dry Eye Questionnaire Irritation Score
Week 0 (Baseline)
|
53.81 Millimeters (mm)
Standard Deviation 26.5
|
|
Dry Eye Questionnaire Irritation Score
Week 3
|
36.22 Millimeters (mm)
Standard Deviation 24.89
|
Adverse Events
Punctal Plug
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
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 at least 60 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER