| CTRI Number |
CTRI/2018/01/011121 [Registered on: 03/01/2018] Trial Registered Prospectively |
| Last Modified On: |
22/06/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical trial on dry eye patients |
|
Scientific Title of Study
|
Analysis of comparative efficacy of a combination formula for a lubricant (Trehalose with sodium hyaluronate 1mg/mL) in the management of ocular surface conditions |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rohit Shetty |
| Designation |
Head of Cornea and Refractive Services |
| Affiliation |
Narayana Nethralaya |
| Address |
Narayana Nethralaya
B Block First floor
room No: 105
121/C, Chord Road, 1st R Block, Rajajinagar,
Bangalore
Bangalore
KARNATAKA
560 010
India |
| Phone |
|
| Fax |
|
| Email |
drrohitshetty@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arkasubhra Ghosh |
| Designation |
Director, GROW Research Laboratory |
| Affiliation |
Narayana Nethralaya |
| Address |
Narayana Nethralaya
GROW research Laboratory, third floor
Narayana Nethralaya Foundation,
3rd Floor, Narayana Nethralaya-2
Bangalore
KARNATAKA
560099
India |
| Phone |
|
| Fax |
|
| Email |
arkasubhra@narayananethralaya.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sriharsha Nagaraj |
| Designation |
Director of Clinical Research |
| Affiliation |
Narayana Nethralaya |
| Address |
Narayana Nethralaya
Director - Clinical Research
Room No 114, 1st Floor, A Block,
121/C Chord Road, 1 R Block,
Rajajinagar, Bangalore - 560010
Bangalore
KARNATAKA
560 010
India |
| Phone |
|
| Fax |
|
| Email |
sriharsha1024@gmail.com |
|
|
Source of Monetary or Material Support
|
| Narayana Nethralaya
121/C, Chord Road, 1 R Block,
Rajajinagar, Bangalore - 560010
Ph:91-80-66121415
|
|
|
Primary Sponsor
|
| Name |
Narayana Nethralaya |
| Address |
Narayana Nethralaya
Narayana Health city, Hosur Road
Bangalore
|
| Type of Sponsor |
Research institution |
|
|
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 Rohit Shetty |
Narayana Nethralaya |
Narayana Nethralaya
Room No 105, 1s Floor, B Block
121/C, Chord Road, 1st R Block, Rajajinagar, Bangalore 560 010
Bangalore
KARNATAKA |
9591236580
drrohitshetty@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Narayaan Netralaya Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Mild to moderate dry eye disease , (1) ICD-10 Condition: H100||Mucopurulent conjunctivitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Trehalose with sodium hyaluronate 1mg/mL |
Drug will give after enrolled study 10 days and follow up with 1 month, 3 Months and 6 Months
Dose: 1mg/mL
Route: eye drops
frequency: 6 times daily
TOTAL duration : 6 months
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Males and Females
2.Age 18 to 65 years,
3.Mild to moderate dry eye disease as per:
i.OSDI score >18
ii.Schirmers II (with anaesthesia) >5 at 5 minutes, < 10 at 5 minutes
iii.TBUT < 7 seconds
iv.Corneal and conjunctival staining ( graded
by NEI and Van Bjisterveld grading)
4.No use of any tear substitute for either eye in the preceding 6 weeks
5.Willing to participate in the study
Inclusion criteria for Arm 2:
6.All patients undergoing corneal refractive surgery without pre-existing dry eye
7.Willing to participate in the study
|
|
| ExclusionCriteria |
| Details |
1.BCVA distance < 6/60
2.Severe blepharitis
3.Eyelid malposition
4.Corneal scar/ opacity
5.Ocular Surface Squamous neoplasia (OSSN)
6.Corneal neovascularisation or pannus
7.cular allergy (except in paediatric population)
8.Any ocular infection in the past 3 months
9.Cataract surgery in the past 3 months
10.Corneal or conjunctival procedure
11.Ocular medications which are known to worsen dry eye like AGM
12.Systemic conditions like collagen vascular disease, rheumatoid arthritis, Steven Johnson syndrome
Exclusion criteria for arm 2
13.Pre-existing dry eye
14.Corneal neovascularisation or pannus
15.Ocular allergy (except in paediatric population)
16.Any ocular infection in the past 3 months
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.The changes in various ocular surface signs and symptoms and quantitative and qualitative analysis of tear film in dry eye induced secondary to laser refractive surgery and effect of various topical eye medications on it
|
10 days, 1 month, 3 months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the inflammatory pathways involved in dry eye and action of each of the medications on those pathways |
6 Months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
09/01/2018 |
| 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
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet decided |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Dry eye disease is a multifactorial disease of the ocular surface associated with symptoms of dryness and visual disturbances.
Study conducting for following parameters analysis 1. The changes in various ocular surface signs and symptoms and quantitative and qualitative analysis of tear film in dry eye induced secondary to laser refractive surgery and effect of various topical eye medications on it 2. The changes in various ocular surface signs and symptoms and quantitative and qualitative analysis of tear film in moderate to severe dry eye and the effect of various topical eye medications on it 3. To study the differences in the performance of these medications in dry eye using various dry eye evaluation techniques. 4. To study the corneal nerve regeneration after laser refractive surgery on Confocal microscopy 5. To study the inflammatory pathways involved in dry eye and action of each of the medications on those pathways 6. To study the mechanism of action of the drugs in the management of dry eye.
| Primary/co-primary Endpoint(s) | Improvement in signs and symptoms of dry eye | | Secondary Endpoint | Reduction of inflammatory cytokine levels in tears | | Safety Endpoint | No inflammation or adverse reaction post treatment. | | |
|