| CTRI Number |
CTRI/2025/04/085631 [Registered on: 25/04/2025] Trial Registered Prospectively |
| Last Modified On: |
24/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect on contrast sensitivity and ocular surface with different formulations of
preservative free drug in glaucoma patients |
|
Scientific Title of Study
|
Effect on contrast sensitivity and ocular surface with different formulations of
preservative free topical Travoprost in treatment naive Primary open angle glaucoma patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vidushi |
| Designation |
Postgraduate Junior Resident |
| Affiliation |
Government Medical College and Hospital Chandigarh |
| Address |
Department of Ophthalmology, Block-D Level-III, GMCH, Sector 32, Chandigarh
Chandigarh
CHANDIGARH
160032
India |
| Phone |
07988934320 |
| Fax |
|
| Email |
dr.vidushi17@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Parul Ichhpujani |
| Designation |
Professor |
| Affiliation |
Government Medical College and Hospital Chandigarh |
| Address |
Department of Ophthalmology, Block-D Level-III, GMCH Sector 32, Chandigarh
Chandigarh
CHANDIGARH
160032
India |
| Phone |
9501071591 |
| Fax |
|
| Email |
itsdrparul@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vidushi |
| Designation |
Postgraduate Junior Resident |
| Affiliation |
Government Medical College and Hospital Chandigarh |
| Address |
Department of Ophthalmology, Block-D Level-III, GMCH, Sector 32, Chandigarh
Chandigarh
CHANDIGARH
160032
India |
| Phone |
07988934320 |
| Fax |
|
| Email |
dr.vidushi17@gmail.com |
|
|
Source of Monetary or Material Support
|
| GMCH CHANDIGARH, Sector-32, Chandigarh, India, 160032 |
|
|
Primary Sponsor
|
| Name |
Dr Vidushi Postgraduate Junior Resident Ophthalmology GMCH |
| Address |
Department of Ophthalmology, Block-D, Level-III, GMCH, SECTOR 32 CHANDIGARH 160032 |
| Type of Sponsor |
Government medical college |
|
|
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 Vidushi |
Government Medical College and Hospital Chandigarh |
Department of Ophthalmology, Block-D, Level-III, Government Medical College and Hospital, Sector 32, Chandigarh
Chandigarh
CHANDIGARH |
7988934320
dr.vidushi17@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE (GMCH, Chandigarh) |
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 |
Travatan |
Travoprost + Polyquad as preservative |
| Intervention |
Travoflo |
Travoprost + ionic buffer as preservative
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed as having primary open angle glaucoma |
|
| ExclusionCriteria |
| Details |
Patients with history of incisional or laser eye surgery in the past 3 months
Any cause for visual impairment other than glaucoma
Any medical condition which in the investigator‟s opinion would preclude the patient
from providing reliable and valid data
Best-corrected visual acuity (BCVA) of less than 20/80
Any sign of secondary glaucoma, significant media opacities, and a history of using oral
or topical steroids |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Central and peripheral SPARCS Scores
DEQ-5 values
tFBUT
Average RNFL thickness |
Baseline, 1 month, 3months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
IOP
Macular GCC |
0, 1 and 3 months |
|
|
Target Sample Size
|
Total Sample Size="18"
Sample Size from India="18"
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)
|
05/05/2025 |
| 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="6"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [dr.vidushi17@gmail.com].
- For how long will this data be available start date provided 28-04-2026 and end date provided 28-03-2030?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
Glaucoma encompasses a range of progressive optic nerve disorders causing retinal ganglion
cell (RGC) loss, optic neuropathy with corresponding visual field defects, potentially leading
to permanent blindness. Loss of RGCs is linked to the elevation of intraocular pressure
(IOP).1 Without IOP reduction treatment, glaucomatous damage can advance from mild field
damage to unilateral blindness in approximately 23 years, while treatment extends this
progression to about 35 years.2 As the primary cause of irreversible blindness worldwide,
glaucoma emerges as a significant public health issue demanding attention and effective
interventions. The United Nations‟ population projections estimates that over 111.8 million
will suffer from glaucoma by 2040.3, 4 Globally, primary open-angle glaucoma (POAG) is the
most prevalent form of glaucoma.5 Based on available data, an estimated 11.2 million
individuals aged over 40 years in India are believed to have glaucoma, underscoring the
significant prevalence of the condition in the country, and POAG affects 6.48 million
persons.6 To make matters worse, the visual compromise results not just from the disease but
also its treatment.
High IOP significantly increases the risk of POAG.7 Uncontrolled POAG and resultant
glaucomatous optic neuropathy (GON) results in irreversible damage to the visual function.8
In some individuals, a reduction in intraocular pressure may lead to partial improvement in
visual field defects.8 In the natural progression of GON, functional vision loss often precedes
detection by standard automated perimetry (SAP).9 Changes in contrast sensitivity (CS) can
be noted before significant visual acuity loss, visible retinal nerve fiber layer (RNFL)
damage, or SAP visual field defects.10
Various studies have documented enhanced central CS in patients with POAG after
undergoing medical treatment for reduction in IOP with topical drugs or surgical reduction of
IOP.6,8,11,12 All topical multi-dose formulations of anti-glaucoma drugs have preservatives for
keeping them sterile and for extending their shelf-life. Preservatives are of two main
categories, detergents or oxidizing agents. Detergent type preservatives, e.g., benzalkonium
chloride (BAK) can be toxic to the ocular surface, especially where exposure is going to be
lifelong and repeated due to the slowly progressive nature of the disease, or if there is pre
existing ocular surface disease (OSD).13 Dry eye disease (DED) induced by preservatives
arises from a intricate interplay of various contributing factors involving ocular surface,
blinking rate and tear film stability. Many antiglaucoma drugs are now using alternative
1
agents to BAK, such as Polyquad or ionic buffer, to have a favourable ocular surface
profile.14
OSD induced dry eye can compromise the CS as well. In the current study we plan to see the
effect of two different types of, BAK free, prostaglandin analogue (PGA), Travoprost,
0.004%, on CS as well as the ocular surface. Travoprost is a synthetic lipophilic isopropyl
ester prodrug of the active compound travoprost free acid, a prostaglandin F2alpha analog
with anti-glaucoma property. Travoprost is hydrolysed to a free acid by corneal esterases, and
then it selectively stimulates the prostaglandin F (FP prostanoid) receptor, thereby increasing
the uveoscleral outflow that leads to a reduction of IOP in open angle glaucomas and ocular
hypertensives. It is instilled once daily at bedtime.
Patients will be randomly assigned to a travoprost formulation preserved with Polyquad
[Polyquaternium-1; PQ], TRAVATAN (Novartis Healthcare Pvt. Ltd.) and another
formulation preserved with Ionic buffered solution, TRAVOFLO (Ipca Laboratories Ltd.).
In the current study we plan to use the Spaeth Richman Contrast Sensitivity Test (SPARCS),
an online computerized assessment incorporating multiple answer choices and a bracketing
technique to determine both central and peripheral CS threshold. Tear film parameters, Dry
Eye Questionnaire-5 (DEQ-5) and Ocular Surface Disease Index (OSDI) will be employed to
ascertain changes in ocular surface at baseline and at 3 months after institution of therapy
with two different BAK free formulations of Travoprost. In terms of discriminating
symptoms of dry eye, performance of the DEQ-5 questionnaire has been found to be
comparable to the OSDI questionnaire. |