Trial Outcomes & Findings for Comparing Treatment of Dry Eye With Intracanalicular Dexamethasone, Restasis, and/or Lotemax (NCT NCT04555694)
NCT ID: NCT04555694
Last Updated: 2023-10-11
Results Overview
The primary outcome measure was the mean corneal surface staining (guided by use of fluorescein and lissamine green) at weeks 4, 8 and 12 from baseline based on the National Eye Institute grading scale. Corneal fluorescein staining was scored from 0 to 3 on the scale (none, better to heavy, worse) in five regions of the cornea and summed for a total score of 0-15.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
30 participants
Primary outcome timeframe
Baseline to Week 4, Week 8 and Week 12
Results posted on
2023-10-11
Participant Flow
Thirty patients were enrolled in the study. 10 patients in each treatment group.
Unit of analysis: Eyes
Participant milestones
| Measure |
Restasis and Lotemax
10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes and Lotemax ophthalmic solution twice a day in both eyes.
Cyclosporine: Used to increase tear production in patients who have dry eye caused by inflammation
Loteprednol Etabonate: Used to treat inflammation of the eye
|
Restasis and Dextenza
10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes, as well as receiving Dextenza insertion in both lower lids.
Cyclosporine: Used to increase tear production in patients who have dry eye caused by inflammation
Dexamethasone Ophthalmic 0.4 Mg Ophthalmic Insert: Used to treat inflammation of the eye
|
Restasis
10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes
Cyclosporine: Used to increase tear production in patients who have dry eye caused by inflammation
|
|---|---|---|---|
|
Overall Study
STARTED
|
10 20
|
10 20
|
10 20
|
|
Overall Study
COMPLETED
|
10 20
|
10 20
|
10 20
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparing Treatment of Dry Eye With Intracanalicular Dexamethasone, Restasis, and/or Lotemax
Baseline characteristics by cohort
| Measure |
Restasis and Lotemax
n=10 Participants
10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes and Lotemax ophthalmic solution twice a day in both eyes.
Cyclosporine: Used to increase tear production in patients who have dry eye caused by inflammation
Loteprednol Etabonate: Used to treat inflammation of the eye
|
Restasis and Dextenza
n=10 Participants
10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes, as well as receiving Dextenza insertion in both lower lids.
Cyclosporine: Used to increase tear production in patients who have dry eye caused by inflammation
Dexamethasone Ophthalmic 0.4 Mg Ophthalmic Insert: Used to treat inflammation of the eye
|
Restasis
n=10 Participants
10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes
Cyclosporine: Used to increase tear production in patients who have dry eye caused by inflammation
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
59 years
n=5 Participants
|
55 years
n=7 Participants
|
62 years
n=5 Participants
|
58 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
10 participants
n=5 Participants
|
30 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 4, Week 8 and Week 12The primary outcome measure was the mean corneal surface staining (guided by use of fluorescein and lissamine green) at weeks 4, 8 and 12 from baseline based on the National Eye Institute grading scale. Corneal fluorescein staining was scored from 0 to 3 on the scale (none, better to heavy, worse) in five regions of the cornea and summed for a total score of 0-15.
Outcome measures
| Measure |
Restasis and Lotemax
n=20 Eyes
10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes and Lotemax ophthalmic solution twice a day in both eyes.
Cyclosporine: Used to increase tear production in patients who have dry eye caused by inflammation
Loteprednol Etabonate: Used to treat inflammation of the eye
|
Restasis and Dextenza
n=20 Eyes
10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes, as well as receiving Dextenza insertion in both lower lids.
Cyclosporine: Used to increase tear production in patients who have dry eye caused by inflammation
Dexamethasone Ophthalmic 0.4 Mg Ophthalmic Insert: Used to treat inflammation of the eye
|
Restasis
n=18 Eyes
10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes
Cyclosporine: Used to increase tear production in patients who have dry eye caused by inflammation
|
|---|---|---|---|
|
Mean Ocular Surface Staining From Baseline
Baseline
|
0.8 Score on a scale
Standard Deviation 1.5
|
0.6 Score on a scale
Standard Deviation 1.0
|
0.5 Score on a scale
Standard Deviation 0.5
|
|
Mean Ocular Surface Staining From Baseline
Week 4
|
0.9 Score on a scale
Standard Deviation 0.9
|
0.6 Score on a scale
Standard Deviation 1.0
|
1.1 Score on a scale
Standard Deviation 1.4
|
|
Mean Ocular Surface Staining From Baseline
Week 8
|
0.0 Score on a scale
Standard Deviation 0.0
|
0.5 Score on a scale
Standard Deviation 1.1
|
0.3 Score on a scale
Standard Deviation 0.6
|
|
Mean Ocular Surface Staining From Baseline
Week 12
|
0.6 Score on a scale
Standard Deviation 1.0
|
0.7 Score on a scale
Standard Deviation 1.4
|
0.5 Score on a scale
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: Baseline to Week 4, Week 8 and Week 12The mean conjunctival staining (guided by use of lissamine green) at weeks 4, 8 and 12 from baseline based on the National Eye Institute grading scale. Conjunctival staining was scored from 0 to 3 on the scale (none, better to heavy, worse) in six regions of the cornea and summed for a total score of 0-18.
Outcome measures
| Measure |
Restasis and Lotemax
n=20 Eyes
10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes and Lotemax ophthalmic solution twice a day in both eyes.
Cyclosporine: Used to increase tear production in patients who have dry eye caused by inflammation
Loteprednol Etabonate: Used to treat inflammation of the eye
|
Restasis and Dextenza
n=20 Eyes
10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes, as well as receiving Dextenza insertion in both lower lids.
Cyclosporine: Used to increase tear production in patients who have dry eye caused by inflammation
Dexamethasone Ophthalmic 0.4 Mg Ophthalmic Insert: Used to treat inflammation of the eye
|
Restasis
n=18 Eyes
10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes
Cyclosporine: Used to increase tear production in patients who have dry eye caused by inflammation
|
|---|---|---|---|
|
Mean Conjunctival Staining
Week 12
|
1.0 Score on a scale
Standard Deviation 1.6
|
0.8 Score on a scale
Standard Deviation 1.7
|
0.7 Score on a scale
Standard Deviation 1.4
|
|
Mean Conjunctival Staining
Baseline
|
1.5 Score on a scale
Standard Deviation 1.8
|
0.5 Score on a scale
Standard Deviation 1.8
|
0.4 Score on a scale
Standard Deviation 0.6
|
|
Mean Conjunctival Staining
Week 4
|
0.9 Score on a scale
Standard Deviation 1.4
|
0.3 Score on a scale
Standard Deviation 0.6
|
0.5 Score on a scale
Standard Deviation 0.7
|
|
Mean Conjunctival Staining
Week 8
|
0.8 Score on a scale
Standard Deviation 1.8
|
0.4 Score on a scale
Standard Deviation 0.8
|
0.3 Score on a scale
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: Baseline to Week 4, Week 8 and Week 12Schirmer Tear Test 1 score, measuring tear production, as measured by a Schirmer's test strip with anesthetic (mm/5min on a strip 0-35mm. 0 mm is worse, \>15 indicates normal production) at week 4, 8 and 12 from Baseline.
Outcome measures
| Measure |
Restasis and Lotemax
n=20 Eyes
10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes and Lotemax ophthalmic solution twice a day in both eyes.
Cyclosporine: Used to increase tear production in patients who have dry eye caused by inflammation
Loteprednol Etabonate: Used to treat inflammation of the eye
|
Restasis and Dextenza
n=20 Eyes
10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes, as well as receiving Dextenza insertion in both lower lids.
Cyclosporine: Used to increase tear production in patients who have dry eye caused by inflammation
Dexamethasone Ophthalmic 0.4 Mg Ophthalmic Insert: Used to treat inflammation of the eye
|
Restasis
n=18 Eyes
10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes
Cyclosporine: Used to increase tear production in patients who have dry eye caused by inflammation
|
|---|---|---|---|
|
Mean Schirmer Tear Test 1 Score
Baseline
|
10.3 Score on a scale
Standard Deviation 7.2
|
14.9 Score on a scale
Standard Deviation 10.3
|
11.6 Score on a scale
Standard Deviation 10.5
|
|
Mean Schirmer Tear Test 1 Score
Week 8
|
12.4 Score on a scale
Standard Deviation 8.4
|
15.8 Score on a scale
Standard Deviation 9.4
|
10.8 Score on a scale
Standard Deviation 6.4
|
|
Mean Schirmer Tear Test 1 Score
Week 12
|
10.1 Score on a scale
Standard Deviation 6.0
|
12.3 Score on a scale
Standard Deviation 7.1
|
9.6 Score on a scale
Standard Deviation 5.5
|
|
Mean Schirmer Tear Test 1 Score
Week 4
|
12.9 Score on a scale
Standard Deviation 9.1
|
15.4 Score on a scale
Standard Deviation 10.1
|
10.1 Score on a scale
Standard Deviation 8.5
|
SECONDARY outcome
Timeframe: Baseline to Week 4, Week 8 and Week 12The time it takes (in seconds) for the tear film to break after blinking at Week 4, 8 and 12 from Baseline
Outcome measures
| Measure |
Restasis and Lotemax
n=20 Eyes
10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes and Lotemax ophthalmic solution twice a day in both eyes.
Cyclosporine: Used to increase tear production in patients who have dry eye caused by inflammation
Loteprednol Etabonate: Used to treat inflammation of the eye
|
Restasis and Dextenza
n=20 Eyes
10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes, as well as receiving Dextenza insertion in both lower lids.
Cyclosporine: Used to increase tear production in patients who have dry eye caused by inflammation
Dexamethasone Ophthalmic 0.4 Mg Ophthalmic Insert: Used to treat inflammation of the eye
|
Restasis
n=18 Eyes
10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes
Cyclosporine: Used to increase tear production in patients who have dry eye caused by inflammation
|
|---|---|---|---|
|
Tear Breakup Time (Seconds)
Basline
|
5.4 Seconds
Standard Deviation 1.5
|
6.6 Seconds
Standard Deviation 2.2
|
5.7 Seconds
Standard Deviation 3.3
|
|
Tear Breakup Time (Seconds)
Week 4
|
6.1 Seconds
Standard Deviation 2.8
|
8.0 Seconds
Standard Deviation 3.6
|
7.4 Seconds
Standard Deviation 3.7
|
|
Tear Breakup Time (Seconds)
Week 8
|
6.2 Seconds
Standard Deviation 2.2
|
7.7 Seconds
Standard Deviation 3.1
|
7.1 Seconds
Standard Deviation 3.4
|
|
Tear Breakup Time (Seconds)
Week 12
|
6.1 Seconds
Standard Deviation 2.4
|
7.7 Seconds
Standard Deviation 2.5
|
7.3 Seconds
Standard Deviation 3.6
|
SECONDARY outcome
Timeframe: Baseline to Week 4, Week 8 and Week 12Tear osmolarity as measured by TearLab (275-307 is considered "homeostatic range") at Week 4, 8 and 12 from Baseline.
Outcome measures
| Measure |
Restasis and Lotemax
n=20 Eyes
10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes and Lotemax ophthalmic solution twice a day in both eyes.
Cyclosporine: Used to increase tear production in patients who have dry eye caused by inflammation
Loteprednol Etabonate: Used to treat inflammation of the eye
|
Restasis and Dextenza
n=20 Eyes
10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes, as well as receiving Dextenza insertion in both lower lids.
Cyclosporine: Used to increase tear production in patients who have dry eye caused by inflammation
Dexamethasone Ophthalmic 0.4 Mg Ophthalmic Insert: Used to treat inflammation of the eye
|
Restasis
n=18 Eyes
10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes
Cyclosporine: Used to increase tear production in patients who have dry eye caused by inflammation
|
|---|---|---|---|
|
Tear Osmolarity
Baseline
|
311.3 mOsM/L
Standard Deviation 19.8
|
295.5 mOsM/L
Standard Deviation 17.4
|
306.9 mOsM/L
Standard Deviation 28.4
|
|
Tear Osmolarity
Week 4
|
307.7 mOsM/L
Standard Deviation 17.3
|
304.4 mOsM/L
Standard Deviation 30.1
|
307.9 mOsM/L
Standard Deviation 24.2
|
|
Tear Osmolarity
Week 8
|
300.1 mOsM/L
Standard Deviation 19.2
|
303.9 mOsM/L
Standard Deviation 22.1
|
295.3 mOsM/L
Standard Deviation 20.7
|
|
Tear Osmolarity
Week 12
|
304.4 mOsM/L
Standard Deviation 28.7
|
299.5 mOsM/L
Standard Deviation 16.2
|
304.6 mOsM/L
Standard Deviation 19.6
|
SECONDARY outcome
Timeframe: Baseline to Week 4, Week 8 and Week 12Meibomian gland scoring on a scale of 1-4 (1 represents clear, liquid secretions and 4 is no secretions) in three regions (nasal, central, temporal) and summed for a single score between 3-12 at Week 4, 8 and 12 from baseline
Outcome measures
| Measure |
Restasis and Lotemax
n=20 Eyes
10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes and Lotemax ophthalmic solution twice a day in both eyes.
Cyclosporine: Used to increase tear production in patients who have dry eye caused by inflammation
Loteprednol Etabonate: Used to treat inflammation of the eye
|
Restasis and Dextenza
n=20 Eyes
10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes, as well as receiving Dextenza insertion in both lower lids.
Cyclosporine: Used to increase tear production in patients who have dry eye caused by inflammation
Dexamethasone Ophthalmic 0.4 Mg Ophthalmic Insert: Used to treat inflammation of the eye
|
Restasis
n=18 Eyes
10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes
Cyclosporine: Used to increase tear production in patients who have dry eye caused by inflammation
|
|---|---|---|---|
|
Meibomian Gland Scores
Baseline
|
7.1 Score on a scale
Standard Deviation 2.1
|
8.7 Score on a scale
Standard Deviation 2.4
|
9.2 Score on a scale
Standard Deviation 2.6
|
|
Meibomian Gland Scores
Week 4
|
6.7 Score on a scale
Standard Deviation 2.5
|
7.6 Score on a scale
Standard Deviation 1.8
|
7.2 Score on a scale
Standard Deviation 1.4
|
|
Meibomian Gland Scores
Week 8
|
6.3 Score on a scale
Standard Deviation 2.6
|
8.3 Score on a scale
Standard Deviation 2.0
|
8.2 Score on a scale
Standard Deviation 2.2
|
|
Meibomian Gland Scores
Week 12
|
6.0 Score on a scale
Standard Deviation 2.3
|
8.7 Score on a scale
Standard Deviation 2.0
|
7.3 Score on a scale
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: Baseline to Week 4, Week 8 and Week 12Dry Eye Questionnaire-5 (5 questions about dry eye symptoms rated from 0, or never to 5, or constantly) total score of 0-22 with higher scores representing worse symptoms at weeks 4, 8 and 12 from baseline
Outcome measures
| Measure |
Restasis and Lotemax
n=20 Eyes
10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes and Lotemax ophthalmic solution twice a day in both eyes.
Cyclosporine: Used to increase tear production in patients who have dry eye caused by inflammation
Loteprednol Etabonate: Used to treat inflammation of the eye
|
Restasis and Dextenza
n=20 Eyes
10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes, as well as receiving Dextenza insertion in both lower lids.
Cyclosporine: Used to increase tear production in patients who have dry eye caused by inflammation
Dexamethasone Ophthalmic 0.4 Mg Ophthalmic Insert: Used to treat inflammation of the eye
|
Restasis
n=18 Eyes
10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes
Cyclosporine: Used to increase tear production in patients who have dry eye caused by inflammation
|
|---|---|---|---|
|
DEQ-5 Score
Week 8
|
9.1 Score on a scale
Standard Deviation 4.0
|
11.3 Score on a scale
Standard Deviation 4.5
|
10.6 Score on a scale
Standard Deviation 2.6
|
|
DEQ-5 Score
Week 12
|
10.2 Score on a scale
Standard Deviation 3.8
|
10.3 Score on a scale
Standard Deviation 6.3
|
9.4 Score on a scale
Standard Deviation 3.1
|
|
DEQ-5 Score
Baseline
|
14.4 Score on a scale
Standard Deviation 2.4
|
14.1 Score on a scale
Standard Deviation 4.0
|
14.4 Score on a scale
Standard Deviation 3.7
|
|
DEQ-5 Score
Week 4
|
11.0 Score on a scale
Standard Deviation 2.4
|
10.6 Score on a scale
Standard Deviation 4.6
|
12.2 Score on a scale
Standard Deviation 2.2
|
Adverse Events
Restasis and Lotemax
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Restasis and Dextenza
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Restasis
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Restasis and Lotemax
n=10 participants at risk
10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes and Lotemax ophthalmic solution twice a day in both eyes.
Cyclosporine: Used to increase tear production in patients who have dry eye caused by inflammation
Loteprednol Etabonate: Used to treat inflammation of the eye
|
Restasis and Dextenza
n=10 participants at risk
10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes, as well as receiving Dextenza insertion in both lower lids.
Cyclosporine: Used to increase tear production in patients who have dry eye caused by inflammation
Dexamethasone Ophthalmic 0.4 Mg Ophthalmic Insert: Used to treat inflammation of the eye
|
Restasis
n=10 participants at risk
10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes
Cyclosporine: Used to increase tear production in patients who have dry eye caused by inflammation
|
|---|---|---|---|
|
Eye disorders
2+ Injection at week 8 visit.
|
0.00%
0/10 • Baseline to Week 12
|
10.0%
1/10 • Baseline to Week 12
|
0.00%
0/10 • Baseline to Week 12
|
|
Eye disorders
Increased Corneal and Conjunctival Staining from Baseline
|
0.00%
0/10 • Baseline to Week 12
|
10.0%
1/10 • Baseline to Week 12
|
0.00%
0/10 • Baseline to Week 12
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place