Dry Eye, Healthy
Conditions
Keywords
Dry eye, Tear duct, Punctal plug
Brief summary
The purpose of this study was to determine the safety and retention times of two different lengths (10 mm and 20 mm) of the MINI MONOKA canicular stent when inserted in the eye for up to three months in subjects with or without dry eye.
Detailed description
This study consisted of 6 visits conducted over a period of 3 months. At Visit 1 (Day 0), the canalicular stent was inserted. If the stent insertion failed, the subject was rescheduled for insertion at the Day 2 visit. If the stent insertion was not successfully completed by the end of the Day 2 visit, the subject was discontinued from the study. Any subject who had the stent inserted but lost the stent (noticed or unnoticed) after the Day 2 Visit was considered to have completed the study.
Interventions
DEVICEMINI MONOKA canalicular stent, 10 mm
40 mm hollow intubation stent composed of a silicon tube and an oval collarette head (plug), cut to 10 mm length
DEVICEMINI MONOKA canalicular stent, 20 mm
40 mm hollow intubation stent composed of a silicon tube and an oval collarette head (plug), cut to 20 mm length
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Sign Informed Consent. * With or without dry eye. * Willing to discontinue contact lenses during the study. * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Chronic, recurrent, or severe inflammatory eye disease. * Ocular trauma within the past 6 months. * Ocular hypertension or glaucoma. * History of punctal plug/canalicular stent insertion. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Retention Time | From baseline (Day 0) up to Month 3 | At all study visits the investigator conducted a slit lamp examination to determine whether the canalicular stent was present. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects Retaining the Stent at Month 3 | Month 3 | At all study visits the investigator conducted a slit lamp examination to determine whether the canalicular stent was present. |
Participant flow
Recruitment details
Subjects were recruited from four US study centers.
Participants by arm
| Arm | Count |
|---|---|
| Canalicular Stent, 10 mm MINI MONOKA canalicular stent (tube), 10 mm, inserted in the lower lacrimal canaliculus (tear duct) of one eye for up to 3 months | 28 |
| Canalicular Stent, 20 mm MINI MONOKA canalicular stent (tube), 20 mm, inserted in the lower lacrimal canaliculus (tear duct) of one eye for up to 3 months | 29 |
| Total | 57 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 4 |
| Overall Study | Patient Decision Unrelated to Ad Event | 0 | 1 |
| Overall Study | Unsuccessful insertion of stent | 2 | 1 |
Baseline characteristics
| Characteristic | Canalicular Stent, 10 mm | Canalicular Stent, 20 mm | Total |
|---|---|---|---|
| Age Continuous | 63.0 years STANDARD_DEVIATION 10.5 | 62.2 years STANDARD_DEVIATION 10.8 | 62.6 years STANDARD_DEVIATION 10.6 |
| Region of Enrollment United States | 28 participants | 29 participants | 57 participants |
| Sex: Female, Male Female | 20 Participants | 20 Participants | 40 Participants |
| Sex: Female, Male Male | 8 Participants | 9 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 5 / 30 | 10 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Primary
Mean Retention Time
At all study visits the investigator conducted a slit lamp examination to determine whether the canalicular stent was present.
Time frame: From baseline (Day 0) up to Month 3
Population: Intent to treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Canalicular Stent, 10 mm | Mean Retention Time | 87.4 Days | Standard Deviation 16.8 |
| Canalicular Stent, 20 mm | Mean Retention Time | 61.9 Days | Standard Deviation 36 |
Secondary
Percentage of Subjects Retaining the Stent at Month 3
At all study visits the investigator conducted a slit lamp examination to determine whether the canalicular stent was present.
Time frame: Month 3
Population: Intent to treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Canalicular Stent, 10 mm | Percentage of Subjects Retaining the Stent at Month 3 | 92.9 Percentage of subjects |
| Canalicular Stent, 20 mm | Percentage of Subjects Retaining the Stent at Month 3 | 48.3 Percentage of subjects |