| CTRI Number |
CTRI/2024/11/076826 [Registered on: 14/11/2024] Trial Registered Prospectively |
| Last Modified On: |
11/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Pharmacoeconomic analysis for cost effectiveness of drugs used for glaucoma |
|
Scientific Title of Study
|
Pharmacoeconomic analysis to determine the relative costeffectiveness of drugs used for primary open angle glaucoma or ocular hypertension
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rima Shah |
| Designation |
Associate Professor in Pharmacology |
| Affiliation |
AIIMS Rajkot |
| Address |
Department of Pharmacology
Academic Block
All India Institute of Medical Sciences, Rajkot
Rajkot
Rajkot
GUJARAT
360110
India |
| Phone |
9825741010 |
| Fax |
|
| Email |
rima_1223@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rima Shah |
| Designation |
Associate Professor in Pharmacology |
| Affiliation |
AIIMS Rajkot |
| Address |
Department of Pharmacology
Academic Block
All India Institute of Medical Sciences, Rajkot
Rajkot
Rajkot
GUJARAT
360110
India |
| Phone |
9825741010 |
| Fax |
|
| Email |
rima_1223@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rima Shah |
| Designation |
Associate Professor in Pharmacology |
| Affiliation |
AIIMS Rajkot |
| Address |
Department of Pharmacology
Academic Block
All India Institute of Medical Sciences, Rajkot
Rajkot
Rajkot
GUJARAT
360110
India |
| Phone |
9825741010 |
| Fax |
|
| Email |
rima_1223@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| AIIMS Rajkot Hospital, Rajkot, Gujarat - 360110, India |
|
|
Primary Sponsor
|
| Name |
None |
| Address |
Not applicable |
| Type of Sponsor |
Other [Not applicable] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
NIL |
| NIL |
NIL |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rima Shah |
AIIMS Rajkot |
Department of Pharmacology and Department of Ophthalmology, AIIMS Rajkot
Para pipaliya, Khanderi
Rajkot
Rajkot
GUJARAT |
9825741010
rima_1223@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Intitutional Ethics Committee AIIMS Rajkot |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H402||Primary angle-closure glaucoma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Primary Open angle glaucoma drugs |
cost effectiveness analysis |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1) Age of 18 years and above
2) either gender
3) newly detected case of POAG/OHT
4) Unilateral or bilateral POAG or OHT with IOP more than 21 mm Hg.
5) Patients with bilateral POAG will be treated for both eyes, but the eye with greater decrease in IOP will be considered as the study eye.
|
|
| ExclusionCriteria |
| Details |
1) Patients with closed anterior chamber angle or acute angle closure glaucoma
2) Any history of intraocular surgery within 6 months of study,
3) Ocular infection or inflammation
4) Established diagnosis of secondary glaucoma
5) Pregnant and lactating females
6) Patients taking any other medication affecting IOP
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Cost effectiveness analysis
|
Cost effectiveness analysis
at 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Adverse reactions analysis |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="123"
Sample Size from India="123"
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)
|
26/11/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Various
treatment options available for glaucoma differ in terms of expense,
effectiveness, and side effects. There is a need of designing a cost effective
treatment especially for chronic illness requiring life-long medication which
can be beneficial for patients, health care providers and the government. All
treatment solutions must be prioritized and rationalised in light of the
growing disparity between available health resources and therapeutic options. The primary concern of the economic analysis of glaucoma treatment should
be on efficiency—that is, the benefits of the treatment relative to the
expenses or sacrifices involved in achieving the goals. Clinical
effectiveness alone is no longer sufficient. Given
the significance of cost-effectiveness, the objective of this research is to
assess the daily and annual costs of treating glaucoma with medications that
are now available in India, as well as the cost-effectiveness analysis.
Hypothesis: As varied treatment options
of wide cost range for glaucoma treatment are available in Indian market, a
more economically sustainable anti-glaucoma medication treatment protocol can
be designed by conducting cost-effectiveness analysis of these drugs. Research question: Given the
long-term financial burden of glaucoma therapy, can a more economically viable
treatment protocol be designed for glaucoma patients? |