Dry Eye, Insulin Sensitivity
Conditions
Keywords
DRY EYE DISEASE, Topical Insulin, Ocular Surface Interface restoration
Brief summary
This is a parallel randomized controlled trial for the treatment of dry eye disease. The main objective is to investigate the efficacy and safety of the use of insulin eye drops in the control of moderate-severe dry eye disease. Topical insulin drops will be compared to artificial tears in improving the ocular surface interface in patients with dry eye disease over 1 year period.
Detailed description
Patients fulfilling the selection criteria will be enrolled from eye OPD of KTH. A written informed consent will be taken after explaining the purpose of study. Data will be collected on a pre-designed structured proforma. Demographic data including age, gender, educational status, socioeconomic status will be noted. Each participant will undergo a complete history assessment and the OSDI score will be calculated after taking extensive history. Ophthalmologic examination, including visual acuity, refraction, slit-lamp examination, corneal staining, schirmer test and TBUT will be performed in each patient. Both eyes will be selected for each secondary outcome measure (TBUT & SCHIRMER TEST). However, only one OSDI score could only be obtained per patient for assessing primary outcome. All the previous medications used for dry eye will be stopped Participants' eyes will be randomized by blocked randomization in a 1:1 ratio to be treated with topical artificial tears (group I) and topical insulin 1U/ml (group II). The patients will be masked for the treatment, but not the principle investigator. Another investigator will prepare the topical insulin according to a written protocol. Participants will be given a white, unlabeled eye dropper containing the same volume of artificial tears or topical insulin for groups I and II respectively. Group I will receive artificial tears (control group) four times daily. Group II will receive topical insulin of 1u/ml four times daily. Follow-up assessments will be conducted at 4, 8 and 12 weeks for each participant to measure changes in TBUT, schirmer test, and OSDI score.
Interventions
DRUGArtificial tear
commercially available artificial tears will be used consisting of same ingredients.
DRUGinsulin human
injection humulin will be used to make topical insulin drops
Sponsors
Khyber Teaching Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
The patients will be masked for the treatment, but not the principle investigator. Another investigator will prepare the topical insulin according to a written protocol. Participants will be given a white, unlabeled eye dropper containing the same volume of artificial tears or topical insulin for groups I and II respectively.
Intervention model description
This will be a randomized controlled trial for the treatment of dry eye disease with two arms: topical artificial tears and topical insulin.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients having Schirmer's test values of less than 10mm after 5 minutes of the procedure recording plus a non-invasive tear breakup time (TBUT) of less than 10 seconds and the Ocular Surface Disease Index (OSDI) of more than 32 (diagnosed as dry eye disease as per the operational definition of this study). * any gender. * aged 18 years and above.
Exclusion criteria
* Patients with active ocular infection, severe ocular surface disease other than Dry eye disease, and those who have undergone ocular surgery within the past 6 months. * Under 18 years old
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| OSDI Score | Baseline to Week 12 | 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. . |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SCHIRMER TEST | Baseline to Week 12 | 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. |
| Tear Film Break up Time | Baseline to Week 12 | 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 |
Countries
Pakistan
Contacts
PRINCIPAL_INVESTIGATORShafiq Tanvee, MBBS, FCPS
KHYBER TEACHING HOSPITAL PESHAWAR KPK PAKISTAN
Participant flow
Recruitment details
at Ophthalmology department Khyber Teaching Hospital Peshawar
Pre-assignment details
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.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 36.63 years STANDARD_DEVIATION 12.98 |
| Baseline OSDI Score, Mean (SD) | 47.81 points STANDARD_DEVIATION 15.85 |
| Baseline Schirmer Test, Mean (SD), mm | 6.36 millimeter STANDARD_DEVIATION 1.33 |
| Baseline TBUT, Mean (SD), sec | 6.47 seconds STANDARD_DEVIATION 1.49 |
| Educated | 31 Participants |
| Employed | 78 Participants |
| Known Diabetic | 22 Participants |
| Race and Ethnicity Not Collected | 0 Participants |
| Satisfactory Socioeconomic Status | 32 Participants |
| Sex: Female, Male Female | 33 Participants |
| Sex: Female, Male Male | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 64 | 0 / 64 |
| other Total, other adverse events | 0 / 64 | 0 / 64 |
| serious Total, serious adverse events | 0 / 64 | 0 / 64 |
Outcome results
None listed