| CTRI Number |
CTRI/2018/10/016227 [Registered on: 31/10/2018] Trial Registered Prospectively |
| Last Modified On: |
30/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study comparing efficacy of two drops in patients undergoing a laser for closed angles |
|
Scientific Title of Study
|
0.1% Nepafenac vs 0.09% Bromfenac Eye Drops in Post Laser Peripheral Iridotomy Inflammation- A Randomised Controlled Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Lavanya G S |
| Designation |
Senior Resident |
| Affiliation |
Aravind Eye Hospital |
| Address |
Room no-21, Department of Glaucoma, Aravind Eye Hospital , Thavvalakuppam , Pondicherry
ARAVIND EYE HOSPITAL, Thavalakuppam , Pondichherry -605007
Pondicherry
PONDICHERRY
605007
India |
| Phone |
0413-2619100 |
| Fax |
|
| Email |
lavanya.shanker@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr R Venkatesh |
| Designation |
Chief Medical Officer |
| Affiliation |
Aravind eye hospital |
| Address |
Room no-21, Department of Glaucoma, Aravind Eye Hospital , Thavvalakuppam , Pondicherry
Pondicherry
PONDICHERRY
605007
India |
| Phone |
|
| Fax |
|
| Email |
venkatesh@pondy.aravind.org |
|
Details of Contact Person
Public Query
|
| Name |
Lavanya G S |
| Designation |
DNB Senior Resident |
| Affiliation |
Aravind eye hospital |
| Address |
Room no-21, Department of Glaucoma, Aravind Eye Hospital , Thavvalakuppam , Pondicherry
Pondicherry
PONDICHERRY
605007
India |
| Phone |
|
| Fax |
|
| Email |
lavanya.shanker@gmail.com |
|
|
Source of Monetary or Material Support
|
| self for thesis
Lavanya G S
Senior Resident
Aravind Eye Hospital , Thavalakuppam , Pondicherry -605007
|
|
|
Primary Sponsor
|
| Name |
Aravind Eye Hospital |
| Address |
Thavalakuppam, Pondicherry- 605007 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Lavanya G S |
Room No-21, Department of Glaucoma , Aravind Eye Hospital |
Thavalakuppam, Pondicherry -605007
Pondicherry
PONDICHERRY |
0413-2619100
lavanya.shanker@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Comittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Primary Angle Closure Suspects
Primary Angle Closure not started on anti glaucoma medications |
| Patients |
(1) ICD-10 Condition: H400||Glaucoma suspect, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
0.09% Bromfenac eye drops , one drop 2 times a day for 14 days |
Non steroidal anti-inflammatory drug |
| Comparator Agent |
0.1% Nepafenac eye drops , one drop 3 times a day for 14 days |
Non steroidal anti-inflammatory drug |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1)Primary angle closure suspects
2)Primary angle closure not started in anti-glaucoma medications post laser peripheral iridotomy
3)Best corrected visual acuity of 6/12 or better |
|
| ExclusionCriteria |
| Details |
1) Corneal pathology like dry eyes
2) Significant cataract which is obscuring undilated disc evaluation
3) PAC patients who are started on glaucoma medication before or immediately after LPI
4) PACG and Secondary angle closure glaucoma
5) History of any topical therapy including NSAID’s within the past 30 days prior to LPI
6) Patient on systemic steroids or non-steroidal anti-inflammatory drugs
7) Any History of Laser or intraocular surgery
8) Pregnant or nursing mothers
9) Monocular patients
10) Any evidence of uveitis (old or new)
11) Patients with bleeding in the eye after the LPI
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the anterior chamber inflammation control between 0.1% Nepafenac eye drops and 0.09% Bromfenac eye drops |
2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)To compare the comfort level of patients between the 0.1% Nepafenac and 0.09% Bromfenac groups by questionnaire (Glaucoma symptom scale questionnaire)
2) To assess any adverse reaction to the two drops in prescribed dosage |
2 weeks |
|
|
Target Sample Size
|
Total Sample Size="158"
Sample Size from India="158"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
08/11/2018 |
| 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="2"
Days="2" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study is a Randomised , single blind , parallel group trial comparing the safety and efficacy between the two Non-steroidal anti-inflammatory eye drops -0.1% Nepafenac and 0.09% Bromfenac eye drops in patients undergoing Nd-YAG peripheral iridotomy conducted at a centre in India. Patients will be randomised into 2 groups following YAG Peripheral iridotomy by computer generated random number to either 0.1% Nepafenac group using drops 3 times/day for 2 weeks or 0.09% Bromfenac group using drops twice daily for 2 weeks. At 2 weeks review, anterior chamber inflammation is graded using Standardised uveitis nomenclature grading group and comfort levels assessed using Glaucoma symptom scale questionnaire. The primary outcome measure is to compare the inflammation control between the two groups at 2 weeks The secondary outcome measure is to compare the comfort level of the patients of the two groups by using questionnaire . Expected outcome- - The study will help us to find out the best NSAID drop in terms of inflammation control - This will help us to give the best possible treatment to the patients following laser iridotomy
|