Trial Outcomes & Findings for Topical Insulin for Ocular Surface Interface in Dry Eye Disease (NCT NCT06939959)
NCT ID: NCT06939959
Last Updated: 2026-08-14
Results Overview
The Ocular Surface Disease Index (OSDI) is a 12-item patient-reported questionnaire assessing dry eye symptom severity and its impact on vision-related function. The OSDI score ranges from 0 to 100, with higher scores indicating worse outcomes (greater symptom severity). This outcome reports the continuous OSDI score at baseline, week 4, week 8 and at Week 12 following initiation of treatment. A reduction in OSDI score from baseline indicates improvement in dry eye symptoms. An OSDI score of \<20 at Week 12 was considered the predefined threshold for clinically meaningful symptomatic improvement. .
COMPLETED
PHASE4
128 participants
Baseline to Week 12
2026-08-14
Participant Flow
at Ophthalmology department Khyber Teaching Hospital Peshawar
Two participants were lost to follow-up. In accordance with the pre-specified study protocol, these participants were retained in the intention-to-treat analysis using their last available data.
Participant milestones
| Measure |
Topical Insulin Group/Arm
Experimental: Insulin Topical insulin 1UI/ml 4 times a day
insulin human: injection humulin will be used to make topical insulin drops
|
Artificial Tears Group/Arm
Artificial tears Artificial tears 4 times a day
Artificial tear: commercially available artificial tears will be used consisting of same ingredients.
|
|---|---|---|
|
Overall Study
STARTED
|
64
|
64
|
|
Overall Study
COMPLETED
|
62
|
64
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Topical Insulin Group/Arm
Experimental: Insulin Topical insulin 1UI/ml 4 times a day
insulin human: injection humulin will be used to make topical insulin drops
|
Artificial Tears Group/Arm
Artificial tears Artificial tears 4 times a day
Artificial tear: commercially available artificial tears will be used consisting of same ingredients.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Topical Insulin Group/Arm
n=64 Participants
Experimental: Insulin Topical insulin 1UI/ml 4 times a day
insulin human: injection humulin will be used to make topical insulin drops
|
Artificial Tears Group/Arm
n=64 Participants
Artificial tears Artificial tears 4 times a day
Artificial tear: commercially available artificial tears will be used consisting of same ingredients.
|
Total
n=128 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35.39 years
STANDARD_DEVIATION 12.74 • n=64 Participants
|
37.25 years
STANDARD_DEVIATION 13.29 • n=64 Participants
|
36.63 years
STANDARD_DEVIATION 12.98 • n=128 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=64 Participants
|
33 Participants
n=64 Participants
|
63 Participants
n=128 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=64 Participants
|
31 Participants
n=64 Participants
|
65 Participants
n=128 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Known Diabetic
|
22 Participants
n=64 Participants
|
23 Participants
n=64 Participants
|
45 Participants
n=128 Participants
|
|
Employed
|
41 Participants
n=64 Participants
|
37 Participants
n=64 Participants
|
78 Participants
n=128 Participants
|
|
Educated
|
34 Participants
n=64 Participants
|
31 Participants
n=64 Participants
|
65 Participants
n=128 Participants
|
|
Satisfactory Socioeconomic Status
|
36 Participants
n=64 Participants
|
32 Participants
n=64 Participants
|
68 Participants
n=128 Participants
|
|
Baseline Schirmer Test, Mean (SD), mm
|
6.36 millimeter
STANDARD_DEVIATION 1.33 • n=64 Participants
|
6.10 millimeter
STANDARD_DEVIATION 1.17 • n=64 Participants
|
6.11 millimeter
STANDARD_DEVIATION 1.31 • n=128 Participants
|
|
Baseline TBUT, Mean (SD), sec
|
6.48 seconds
STANDARD_DEVIATION 1.70 • n=64 Participants
|
6.47 seconds
STANDARD_DEVIATION 1.49 • n=64 Participants
|
6.48 seconds
STANDARD_DEVIATION 1.59 • n=128 Participants
|
|
Baseline OSDI Score, Mean (SD)
|
44.67 points
STANDARD_DEVIATION 16.70 • n=64 Participants
|
47.81 points
STANDARD_DEVIATION 15.85 • n=64 Participants
|
46.24 points
STANDARD_DEVIATION 16.29 • n=128 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 12Population: For each participant, the eye with the higher OSDI score at baseline was designated the study eye and included in the analysis
The Ocular Surface Disease Index (OSDI) is a 12-item patient-reported questionnaire assessing dry eye symptom severity and its impact on vision-related function. The OSDI score ranges from 0 to 100, with higher scores indicating worse outcomes (greater symptom severity). This outcome reports the continuous OSDI score at baseline, week 4, week 8 and at Week 12 following initiation of treatment. A reduction in OSDI score from baseline indicates improvement in dry eye symptoms. An OSDI score of \<20 at Week 12 was considered the predefined threshold for clinically meaningful symptomatic improvement. .
Outcome measures
| Measure |
Topical Insulin Group/Arm
n=64 Participants
Experimental: Insulin Topical insulin 1UI/ml 4 times a day
insulin human: injection humulin will be used to make topical insulin drops
|
Artificial Tears Group/Arm
n=64 Participants
Artificial tears Artificial tears 4 times a day
Artificial tear: commercially available artificial tears will be used consisting of same ingredients.
|
|---|---|---|
|
OSDI Score
Baseline
|
44.67 score on a scale
Standard Deviation 16.70
|
47.81 score on a scale
Standard Deviation 15.85
|
|
OSDI Score
4 weeks
|
33.03 score on a scale
Standard Deviation 12.18
|
37.31 score on a scale
Standard Deviation 11.58
|
|
OSDI Score
8 weeks
|
22.87 score on a scale
Standard Deviation 8.58
|
30.66 score on a scale
Standard Deviation 11.36
|
|
OSDI Score
12 weeks
|
15.44 score on a scale
Standard Deviation 7.67
|
23.81 score on a scale
Standard Deviation 12.29
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: Change in Schirmer Test Value at 12 Weeks: the eye in which the schirmer test measurement was lower was included in the study
Schirmer's test (without anaesthesia) measures aqueous tear production as the length of wetting on a standardized 35 mm filter paper strip over 5 minutes, range 0-35 mm. Higher values indicate better outcome (greater tear production)." Unit of Measure: "mm.The treatment will be deemed effective if Schirmer's test values are above 10mm after 5 minutes, TBUT of more than 10 seconds s achieved at 12 weeks of the initiation of treatment.
Outcome measures
| Measure |
Topical Insulin Group/Arm
n=64 Participants
Experimental: Insulin Topical insulin 1UI/ml 4 times a day
insulin human: injection humulin will be used to make topical insulin drops
|
Artificial Tears Group/Arm
n=64 Participants
Artificial tears Artificial tears 4 times a day
Artificial tear: commercially available artificial tears will be used consisting of same ingredients.
|
|---|---|---|
|
SCHIRMER TEST
Baseline
|
6.36 mm
Standard Deviation 1.30
|
6.11 mm
Standard Deviation 1.17
|
|
SCHIRMER TEST
4 weeks
|
8.02 mm
Standard Deviation 1.35
|
6.35 mm
Standard Deviation 1.37
|
|
SCHIRMER TEST
8 weeks
|
10.50 mm
Standard Deviation 1.55
|
7.31 mm
Standard Deviation 1.74
|
|
SCHIRMER TEST
12 weeks
|
11.11 mm
Standard Deviation 1.40
|
8.52 mm
Standard Deviation 1.50
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: The eye with decreased tear film break up time was included in the study
Fluorescein tear break-up time (TBUT) measures tear film stability as the time, in seconds, for the first dry spot to appear in the stained tear film after a blink, mean of three readings. Higher values indicate better outcome (more stable tear film). Unit of Measure: seconds Change in Tear Break-Up Time (TBUT) at 12 Weeks
Outcome measures
| Measure |
Topical Insulin Group/Arm
n=64 Participants
Experimental: Insulin Topical insulin 1UI/ml 4 times a day
insulin human: injection humulin will be used to make topical insulin drops
|
Artificial Tears Group/Arm
n=64 Participants
Artificial tears Artificial tears 4 times a day
Artificial tear: commercially available artificial tears will be used consisting of same ingredients.
|
|---|---|---|
|
Tear Film Break up Time
Baseline
|
6.48 seconds
Standard Deviation 1.70
|
6.47 seconds
Standard Deviation 1.49
|
|
Tear Film Break up Time
4 weeks
|
8.77 seconds
Standard Deviation 1.54
|
7.11 seconds
Standard Deviation 1.04
|
|
Tear Film Break up Time
8 weeks
|
9.73 seconds
Standard Deviation 1.25
|
7.97 seconds
Standard Deviation 0.96
|
|
Tear Film Break up Time
12 weeks
|
10.83 seconds
Standard Deviation 1.18
|
9.20 seconds
Standard Deviation 1.83
|
Adverse Events
Topical Insulin Group/Arm
Artificial Tears Group/Arm
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
- Publication restrictions are in place