Trial Outcomes & Findings for SLlt Stent II Lacrimal Stent for the Treatment of Nasolacrimal Duct Obstruction (NCT NCT03705000)
NCT ID: NCT03705000
Last Updated: 2026-02-25
Results Overview
Adverse events will be recorded from the time of surgical implantation of the device until the final visit. Ophthalmic complications or adverse events that are observed by the investigator or reported by the subject will be recorded on the CRFs. For all adverse effects, sufficient information will be pursued and/or obtained so as to permit 1) an adequate determination of the outcome of the effect (i.e., whether the effect should be classified as a serious adverse effect) and; 2) an assessment of the causal relationship between the adverse effect and the investigational device or, if applicable, the other study treatment or diagnostic product(s).
TERMINATED
NA
5 participants
Surgery to final exit visit (Month 4-7)
2026-02-25
Participant Flow
Participant milestones
| Measure |
Slit Stent II
The Slit Stent II (investigational) device is created by modifying an existing FDA cleared lacrimal stent (BIKA, manufactured by FCI Opthalmics) by adding additional 3 mm and 35 mm long slits of equal depth.
Slit Stent II: The Slit-Stent II device is created by modifying the BIKA for DCR lacrimal stent through the addition of a center slit, 12 ± 1.5 mm in length, and two lateral slits 32 ± 4.5 mm in length, each having identical depth measurements to facilitate the drainage of tears. The BIKA for DCR is a sterile, single-use device that is FDA cleared as part of the BIKA family of devices under K911109..There are no changes to the raw materials used in making the modifications to the BIKA for DCR during the manufacturing of the Slit Stent II.
|
BIKA for DCR
The BIKA for DCR is a sterile, single-use device, and is an FDA cleared device.
BIKA for DCR: The BIKA for DCR lacrimal stent is a bicanalicular intubation device used for intubation of the lacrimal drainage apparatus, especially in cases of dacryocystorhinostomy (conventional or laser). The silicone tube acts as a conformer during the healing process while facilitating drainage of tears through capillary action around the stent. In cases of canalicular lacerations, the silicone tube guides wound healing and prevents the onset of synechia. The BIKA for DCR is a sterile, single-use device, and is an FDA cleared device
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
2
|
|
Overall Study
COMPLETED
|
3
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
SLlt Stent II Lacrimal Stent for the Treatment of Nasolacrimal Duct Obstruction
Baseline characteristics by cohort
| Measure |
Slit Stent II
n=3 Participants
The Slit Stent II (investigational) device is created by modifying an existing FDA cleared lacrimal stent (BIKA, manufactured by FCI Opthalmics) by adding additional 3 mm and 35 mm long slits of equal depth.
Slit Stent II: The Slit-Stent II device is created by modifying the BIKA for DCR lacrimal stent through the addition of a center slit, 12 ± 1.5 mm in length, and two lateral slits 32 ± 4.5 mm in length, each having identical depth measurements to facilitate the drainage of tears. The BIKA for DCR is a sterile, single-use device that is FDA cleared as part of the BIKA family of devices under K911109..There are no changes to the raw materials used in making the modifications to the BIKA for DCR during the manufacturing of the Slit Stent II.
|
BIKA for DCR
n=2 Participants
The BIKA for DCR is a sterile, single-use device, and is an FDA cleared device.
BIKA for DCR: The BIKA for DCR lacrimal stent is a bicanalicular intubation device used for intubation of the lacrimal drainage apparatus, especially in cases of dacryocystorhinostomy (conventional or laser). The silicone tube acts as a conformer during the healing process while facilitating drainage of tears through capillary action around the stent. In cases of canalicular lacerations, the silicone tube guides wound healing and prevents the onset of synechia. The BIKA for DCR is a sterile, single-use device, and is an FDA cleared device
|
Total
n=5 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.8 years
n=24 Participants
|
68.1 years
n=20 Participants
|
62.5 years
n=40 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=24 Participants
|
2 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=24 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=24 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=24 Participants
|
2 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=24 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=24 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=24 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=24 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=24 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=24 Participants
|
2 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=24 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=24 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Region of Enrollment
United States
|
3 Participants
n=24 Participants
|
2 Participants
n=20 Participants
|
5 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: Surgery to final exit visit (Month 4-7)Adverse events will be recorded from the time of surgical implantation of the device until the final visit. Ophthalmic complications or adverse events that are observed by the investigator or reported by the subject will be recorded on the CRFs. For all adverse effects, sufficient information will be pursued and/or obtained so as to permit 1) an adequate determination of the outcome of the effect (i.e., whether the effect should be classified as a serious adverse effect) and; 2) an assessment of the causal relationship between the adverse effect and the investigational device or, if applicable, the other study treatment or diagnostic product(s).
Outcome measures
| Measure |
Slit Stent II
n=3 Participants
The Slit Stent II (investigational) device is created by modifying an existing FDA cleared lacrimal stent (BIKA, manufactured by FCI Opthalmics) by adding additional 3 mm and 35 mm long slits of equal depth.
Slit Stent II: The Slit-Stent II device is created by modifying the BIKA for DCR lacrimal stent through the addition of a center slit, 12 ± 1.5 mm in length, and two lateral slits 32 ± 4.5 mm in length, each having identical depth measurements to facilitate the drainage of tears. The BIKA for DCR is a sterile, single-use device that is FDA cleared as part of the BIKA family of devices under K911109..There are no changes to the raw materials used in making the modifications to the BIKA for DCR during the manufacturing of the Slit Stent II.
|
BIKA for DCR
n=2 Participants
The BIKA for DCR is a sterile, single-use device, and is an FDA cleared device.
BIKA for DCR: The BIKA for DCR lacrimal stent is a bicanalicular intubation device used for intubation of the lacrimal drainage apparatus, especially in cases of dacryocystorhinostomy (conventional or laser). The silicone tube acts as a conformer during the healing process while facilitating drainage of tears through capillary action around the stent. In cases of canalicular lacerations, the silicone tube guides wound healing and prevents the onset of synechia. The BIKA for DCR is a sterile, single-use device, and is an FDA cleared device
|
|---|---|---|
|
Safety, as Measured by Number of Subjects With at Least One Adverse Event
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 1-4 month post-operative follow-up visitPopulation: Data for one participant in the BIKA arm is unavailable because it was not collected at a 30-120 day visit. Therefore the other BIKA participant's data is not being shown because that would not be summary, but individual data, which is not the statutory intent of ClinicalTrials.gov and would violate the required informed consent language that says, "at most, summary data will be shown."
The effectiveness parameter evaluated will be the mean composite score for the GBI administered post-treatment at the 1-4 month post-operative follow-up visit. Scores can range from -100 to 100 where -100 represents decline in symptoms or function and 100 represents greatest improvement.
Outcome measures
| Measure |
Slit Stent II
n=3 Participants
The Slit Stent II (investigational) device is created by modifying an existing FDA cleared lacrimal stent (BIKA, manufactured by FCI Opthalmics) by adding additional 3 mm and 35 mm long slits of equal depth.
Slit Stent II: The Slit-Stent II device is created by modifying the BIKA for DCR lacrimal stent through the addition of a center slit, 12 ± 1.5 mm in length, and two lateral slits 32 ± 4.5 mm in length, each having identical depth measurements to facilitate the drainage of tears. The BIKA for DCR is a sterile, single-use device that is FDA cleared as part of the BIKA family of devices under K911109..There are no changes to the raw materials used in making the modifications to the BIKA for DCR during the manufacturing of the Slit Stent II.
|
BIKA for DCR
The BIKA for DCR is a sterile, single-use device, and is an FDA cleared device.
BIKA for DCR: The BIKA for DCR lacrimal stent is a bicanalicular intubation device used for intubation of the lacrimal drainage apparatus, especially in cases of dacryocystorhinostomy (conventional or laser). The silicone tube acts as a conformer during the healing process while facilitating drainage of tears through capillary action around the stent. In cases of canalicular lacerations, the silicone tube guides wound healing and prevents the onset of synechia. The BIKA for DCR is a sterile, single-use device, and is an FDA cleared device
|
|---|---|---|
|
Glasgow Benefit Inventory (GBI) Questionnaire (Quality of Life)
|
7.33 score on a scale
Interval -16.7 to 41.7
|
—
|
SECONDARY outcome
Timeframe: 1-4 months post operativePopulation: Data for 1 participant in the BIKA arm is unavailable because it was not collected at a 30-120 day visit. Therefore the other BIKA participant's data is not being shown because that would not be summary, but individual data, which is not the statutory intent of ClinicalTrials.gov and would violate the required informed consent language that says, "at most, summary data will be shown."
The Lac-Q questionnaire, published in 2011, is a patient symptom questionnaire developed for lacrimal drainage surgery.1-2 The questionnaire contains two scores, one is specific for eye-symptoms (14 points for each eye), and the other assesses the social impact of symptoms (5 points) . The scores are combined for a single Lac-Q score, whose lowest possible score can be 0 and highest score is 33, where 0 represents no problems related to watery eyes and 33 represents the most possible symptoms and social challenge from them.
Outcome measures
| Measure |
Slit Stent II
n=3 Participants
The Slit Stent II (investigational) device is created by modifying an existing FDA cleared lacrimal stent (BIKA, manufactured by FCI Opthalmics) by adding additional 3 mm and 35 mm long slits of equal depth.
Slit Stent II: The Slit-Stent II device is created by modifying the BIKA for DCR lacrimal stent through the addition of a center slit, 12 ± 1.5 mm in length, and two lateral slits 32 ± 4.5 mm in length, each having identical depth measurements to facilitate the drainage of tears. The BIKA for DCR is a sterile, single-use device that is FDA cleared as part of the BIKA family of devices under K911109..There are no changes to the raw materials used in making the modifications to the BIKA for DCR during the manufacturing of the Slit Stent II.
|
BIKA for DCR
The BIKA for DCR is a sterile, single-use device, and is an FDA cleared device.
BIKA for DCR: The BIKA for DCR lacrimal stent is a bicanalicular intubation device used for intubation of the lacrimal drainage apparatus, especially in cases of dacryocystorhinostomy (conventional or laser). The silicone tube acts as a conformer during the healing process while facilitating drainage of tears through capillary action around the stent. In cases of canalicular lacerations, the silicone tube guides wound healing and prevents the onset of synechia. The BIKA for DCR is a sterile, single-use device, and is an FDA cleared device
|
|---|---|---|
|
Lac-Q Score
|
4 score on a scale
Interval 0.0 to 12.0
|
—
|
Adverse Events
Slit Stent II
BIKA for DCR
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Slit Stent II
n=3 participants at risk
The Slit Stent II (investigational) device is created by modifying an existing FDA cleared lacrimal stent (BIKA, manufactured by FCI Opthalmics) by adding additional 3 mm and 35 mm long slits of equal depth.
Slit Stent II: The Slit-Stent II device is created by modifying the BIKA for DCR lacrimal stent through the addition of a center slit, 12 ± 1.5 mm in length, and two lateral slits 32 ± 4.5 mm in length, each having identical depth measurements to facilitate the drainage of tears. The BIKA for DCR is a sterile, single-use device that is FDA cleared as part of the BIKA family of devices under K911109..There are no changes to the raw materials used in making the modifications to the BIKA for DCR during the manufacturing of the Slit Stent II.
|
BIKA for DCR
n=2 participants at risk
The BIKA for DCR is a sterile, single-use device, and is an FDA cleared device.
BIKA for DCR: The BIKA for DCR lacrimal stent is a bicanalicular intubation device used for intubation of the lacrimal drainage apparatus, especially in cases of dacryocystorhinostomy (conventional or laser). The silicone tube acts as a conformer during the healing process while facilitating drainage of tears through capillary action around the stent. In cases of canalicular lacerations, the silicone tube guides wound healing and prevents the onset of synechia. The BIKA for DCR is a sterile, single-use device, and is an FDA cleared device
|
|---|---|---|
|
Surgical and medical procedures
surgical removal of the stent
|
33.3%
1/3 • up to 7 monhs
|
0.00%
0/2 • up to 7 monhs
|
|
Eye disorders
foreign body sensation in nose
|
33.3%
1/3 • up to 7 monhs
|
0.00%
0/2 • up to 7 monhs
|
|
Eye disorders
Nasal mucosa or caruncular irritation
|
33.3%
1/3 • up to 7 monhs
|
0.00%
0/2 • up to 7 monhs
|
|
Eye disorders
itching in medial corner of eyelid
|
0.00%
0/3 • up to 7 monhs
|
50.0%
1/2 • up to 7 monhs
|
|
Eye disorders
increased tearing and itching (day1)
|
0.00%
0/3 • up to 7 monhs
|
50.0%
1/2 • up to 7 monhs
|
|
Eye disorders
sticky sensation right eye
|
33.3%
1/3 • up to 7 monhs
|
0.00%
0/2 • up to 7 monhs
|
|
Eye disorders
irritation or discomfort
|
33.3%
1/3 • up to 7 monhs
|
0.00%
0/2 • up to 7 monhs
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place