| CTRI Number |
CTRI/2024/02/063013 [Registered on: 22/02/2024] Trial Registered Prospectively |
| Last Modified On: |
16/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Using smart phone app to assess the correct usage of glaucoma drops |
|
Scientific Title of Study
|
Smart Phone App Based Measurement of Short-Term Adherence to Anti Glaucoma Medications: A Randomized Control Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Usha Tejaswini S |
| Designation |
Medical officer |
| Affiliation |
Aravind Eye Hospital, Pondicherry |
| Address |
Aravind Eye Hospital, 1st floor, room number 21, Department of glaucoma, Thavalakuppam,
Cuddalore main road, Pondicherry
Pondicherry
PONDICHERRY
605007
India |
| Phone |
9916808738 |
| Fax |
|
| Email |
drushatejaswini@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Usha Tejaswini S |
| Designation |
Medical officer |
| Affiliation |
Aravind Eye Hospital, Pondicherry |
| Address |
Aravind Eye Hospital, 1st floor, room number 21, Department of glaucoma,Thavalakuppam,
Cuddalore main road, Pondicherry
Pondicherry
PONDICHERRY
605007
India |
| Phone |
9916808738 |
| Fax |
|
| Email |
drushatejaswini@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Usha Tejaswini S |
| Designation |
Medical officer |
| Affiliation |
Aravind Eye Hospital, Pondicherry |
| Address |
Aravind Eye Hospital, 1st floor, room number 21, Department of glaucoma,Thavalakuppam,
Cuddalore main road, Pondicherry
Pondicherry
PONDICHERRY
605007
India |
| Phone |
9916808738 |
| Fax |
|
| Email |
drushatejaswini@gmail.com |
|
|
Source of Monetary or Material Support
|
| Aravind Eye Hospital, Cuddalore main road, Thavalakuppam, Pondicherry |
|
|
Primary Sponsor
|
| Name |
Aravind Eye Hospital |
| Address |
Aravind Eye Hospital, Cuddalore main road, Thavalakuppam, Pondicherry |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Usha Tejaswini S |
Aravind Eye Hospital |
Aravind Eye hospital,1st floor, room number 21, Department of glaucoma, Cuddalore main road, thavalakuppam, pondicherry
Pondicherry
PONDICHERRY |
9916808738
drushatejaswini@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee, Aravind eye hospital, Pondicherry |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H401||Open-angle glaucoma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Adherence to anti glaucoma drops when free sample is provided |
Comparing the adherence to anti glaucoma medications, either Timolol maleate or Latanoprost once daily application, when they are provided free of cost using a smart phone based reminder app |
| Comparator Agent |
Adherence to anti glaucoma drops when patients are expected to purchase them from pharmacy |
Comparing the adherence to anti glaucoma medications, either Timolol maleate or Latanoprost once daily application, when patients purchase the drops on their own by using a smart phone based reminder app |
|
|
Inclusion Criteria
|
| Age From |
18.00 Day(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients aged 18 years or more who are willing to participate
2.Newly diagnosed patients with open angle glaucoma (including primary open angle glaucoma, juvenile open angle glaucoma, pigmentary dispersion glaucoma, pseudoexfoliation glaucoma and normal tension glaucoma)
3.Initiated treatment with a once-daily dose of timolol or latanoprost alone, in both eyes
4.Readily access an Åndroid mobile operating system smartphone and internet service by either the patient or the patient’s caregiver
5.Have the ability to successfully self-administer a drop of IOP lowering medication or patients with a caregiver that can administer the drops for them
|
|
| ExclusionCriteria |
| Details |
1.Patients who are unable to obtain drops locally
2.Patients under monocular ocular hypotensive treatment
3.Patients with secondary glaucomas (all except Pigmentary and Pseudoexfoliation glaucoma)
4.Patients that require surgical intervention for glaucoma or other ocular disease
5.Patients with other ocular co-morbidities, which may need intervention for the same
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the adherence between the group which receives free drug sample and the group which buys the medications on there own for 60 days as measured by the smart phone app (as measured by the EyePhone© App) |
Adherence to AGM will be measured based on response to the phone app and questionnaire based survey at 2 months after which cross-over will be done between the groups and at 4th month the same will be repeated |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
-To evaluate various measures of adherence & identify barriers for good adherence (dosing errors, coverage, inter-dose interval, percent of doses taken)
-Correlation between self-reported adherence via questionnaire vs. recorded live responses over time using the EyePhone app
-Feasibility of using the EyePhone app for monitoring of patients in the south Indian population
-The association between adherence on measured IOP
|
1.Baseline evaluation at the time of recruitment
2. At 2 months from recruitment
3. At 4 months from recruitment |
|
|
Target Sample Size
|
Total Sample Size="186"
Sample Size from India="186"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/03/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This prospective, randomized, crossover study aims to assess the short-term effect of providing a free sample of ocular hypotensive medication on the adherence patterns of glaucoma patients, in terms of: 1) daily use of drops 2) obtaining medication refills in a timely manner We are also aiming to assess the applicability of the EyePhone© App, which is a free non-commercial reminder application, available for the Åndroid mobile operating system, designed specifically for the needs of glaucoma patients and allows self-monitoring of adherence. Over one month of follow-up, use of the app has been shown to significantly improve adherence to topical IOP-lowering medications among glaucoma patients in Israel.
We hypothesize that: 1) Patients who are given an initial free supply of ocular hypotensive medications will have better medication adherence in the short term (when the free supply is no longer available) than patients who need to purchase the medications on their own. 2) Patients who are given a free initial supply of ocular hypotensive medication will have better adherence and renew IOP lowering prescriptions in a more timely fashion than patients who do not receive free supply. 3) Patients who are given an initial free supply of ocular hypotensive medication will have overall better IOP control than patients who do not receive any samples.
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