| CTRI Number |
CTRI/2010/091/000329 [Registered on: 06/04/2010] |
| Last Modified On: |
24/11/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
Modification(s)
|
A clinical Trial in patients with Seasonal Allergic conjunctivitis.Clinical trial is to study efficacy, safety and tolerability of Desonide ophthalmic solution in comparison to Ketorolac Tromethamine ophthalmic solution (reference product). |
Scientific Title of Study
Modification(s)
|
A Comparative, Randomized, Double blind, Multicentric, Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Desonide 0.25% ophthalmic solution vs. Ketorolac tromethamine 0.5% ophthalmic solution in patients with Seasonal Allergic conjunctivitis. |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| APL/CT/ 09/032 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Shailesh Singh |
| Designation |
Associate Vice President DRA and R&D |
| Affiliation |
Ajanta Pharma Ltd, Advent |
| Address |
Ajanta Pharma Ltd., Advent
43/44, ABCD, Charkop Industrial Estate, Kandivli (W)
Mumbai
MAHARASHTRA
400 067
India |
| Phone |
022-66062112 |
| Fax |
022-66062100 |
| Email |
shaileshs@ajantapharma.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Shailesh Singh |
| Designation |
Associate Vice President DRA and R&D |
| Affiliation |
Ajanta Pharma Ltd, Advent |
| Address |
Ajanta Pharma Ltd., Advent
43/44, ABCD, Charkop Industrial Estate, Kandivli (W)
Mumbai
MAHARASHTRA
400 067
India |
| Phone |
022-66062112 |
| Fax |
022-66062100 |
| Email |
shaileshs@ajantapharma.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Shailesh Singh |
| Designation |
Associate Vice President DRA and R&D |
| Affiliation |
Ajanta Pharma Ltd, Advent |
| Address |
Ajanta Pharma Ltd., Advent
43/44, ABCD, Charkop Industrial Estate, Kandivli (W)
Mumbai
MAHARASHTRA
400 067
India |
| Phone |
022-66062112 |
| Fax |
022-66062100 |
| Email |
shaileshs@ajantapharma.com |
|
Source of Monetary or Material Support
Modification(s)
|
|
Primary Sponsor
Modification(s)
|
| Name |
Ajanta Pharma Ltd |
| Address |
Ajanta Pharma Ltd., Advent 43/44, ABCD, Charkop Industrial Estate,
Kandivli (W)
Mumbai
MAHARASHTRA
400 067
India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
Details of Secondary Sponsor
Modification(s)
|
|
Countries of Recruitment
Modification(s)
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr.K. Rathna Kumar |
Aarupadai Veedu Medical College and Hospital |
Puducherry,-
Pondicherry
PONDICHERRY |
09443877019
drkrkumar@gmail.com |
| Dr.H.N. Sowbhagya |
Deeksha Hospital |
#387/347, B.B.Road, ,Nehrunagar, Yelahanka Old Town-560 064
Bangalore
KARNATAKA |
08105161033
drsoubagya@gmail.com |
| Dr. Sohan Narkhede |
OM Netralaya |
Siddhi-Prerana Complex, Sai Chowk,Navi Sanghvi -411027
Pune
MAHARASHTRA |
09850019944
sohan_narkhede@yahoo.com |
| Dr Yogesh Toshniwal |
Vinit Netralaya |
5 Basaveshwar Hall,Chandranagar,-
Latur
MAHARASHTRA |
09422655390
yogeshtoshniwaldr@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Aarupadai Veedu Medical College and Hospital, Pondicherry. |
Approved |
| Deekasha Hospital, 387/347, Next to post office, B B Road, Nehrunagar, Yelahanka Old Towen, Banglore. |
Approved |
| Jagruti Independent Ethics Committee Bandra Mumbai 400 050 |
Approved |
| Jagruti Independent Ethics Committee Bandra Mumbai 400 050 |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H108||Other conjunctivitis, Seasonal Allergic conjunctivitis, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Desonide 0.25% ophthalmic solution |
Days 0-3: Two drops per eye four times a day. Days 4 to 6: one drop per eye four times a day. Days 7 to 14: one drop per eye three times a day. |
| Comparator Agent |
Ketorolac tromethamine 0.5% ophthalmic solution |
Days 0-3: Two drops per eye four times a day. Days 4 to 6: one drop per eye four times a day. Days 7 to 14: one drop per eye three times a day. |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. History of seasonal allergic conjunctivitis.
2. Presence of bilateral ocular itching/conjunctival hyperemia (redness) at baseline.
3. Written informed consent to participate in the trial. |
|
| ExclusionCriteria |
| Details |
1. Patients < 18 & > 60 years.
2. A history of hypersensitivity to corticosteroids.
3. Active bacterial or viral conjunctivitis or history of ocular herpes.
4. Presence or history of severe dry eye.
5. Use of contact lenses during the course of the study.
6. Bestcorrected visual acuity (Snellen) in either eye worse than 20/100.
7. History of ocular surgery or laser within the previous 6 months;
8. Use of topical (ocular) or systemic corticosteroids within 2 weeks before the start of the study;
9. Participation in a clinical trial with an investigation drug within 30 days proceeding day one of this study.
10. Any condition that, in the opinion of the investigator, does not justify the patient?s inclusion in the study.
|
|
Method of Generating Random Sequence
Modification(s)
|
Computer generated randomization |
Method of Concealment
Modification(s)
|
Pharmacy-controlled Randomization |
Blinding/Masking
Modification(s)
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| slit lamp examination |
Day 0, Day 3, Day 7 and Day 14. |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Redness of eye, Ocular itching, eyelid swelling, tearing, photophobia, mucous discharge, foreign body sensation |
Day 0, Day 3, Day 7 and Day 14. |
| safety and tolerability |
Day 0,Day 3, Day 7 and Day 14. |
| Global assessment |
Day 14 |
|
Target Sample Size
Modification(s)
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
12/04/2010 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="0"
Months="4"
Days="2" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This study is a Comparative, Randomized, Double blind, Multicentric, Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Desonide 0.25% ophthalmic solution and Ketorolac tromethamine 0.5% ophthalmic solution in 100 patients with Seasonal Allergic conjunctivitis. Date of first enrollment will be 12 April 2010.
The primary outcome measures will be slit lamp examination at day 0, Day 3, Day 7 and Day 14. The secondary outcome measures will be assessed Redness of eye, Ocular itching, eyelid swelling, tearing, photophobia, mucous discharge, foreign body sensation at Day 0, Day 3, Day 7 and Day 14, safety and tolerability at Day 0, Day 3, Day 7 and Day 14 & Global assessment Day 14. |