| CTRI Number |
CTRI/2024/02/062930 [Registered on: 21/02/2024] Trial Registered Prospectively |
| Last Modified On: |
04/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A post market clinical follow up study of Sterile Hydroxy Propyl Methyl Cellulose Eye Drops |
|
Scientific Title of Study
|
A post market clinical follow up prospective study to evaluate safety and performance of
Sterile Hydroxy Propyl Methyl Cellulose Eye Drops |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| AMH1-12-2023, Rev. No:00, date:09.01.2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Chethan S Sadanand |
| Designation |
Ophthalmic Surgeon |
| Affiliation |
Chethana Eye Care Centre |
| Address |
Chethana Eye Care Centre
1st Floor, Room No:4,
Nagawara Main Rd, Bengaluru, Karnataka 560045
Bangalore
KARNATAKA
560045
India |
| Phone |
9900122287 |
| Fax |
|
| Email |
chethan.sadanand@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chethan S Sadanand |
| Designation |
Ophthalmic Surgeon |
| Affiliation |
Chethana Eye Care Centre |
| Address |
Chethana Eye Care Centre
1st Floor, Room No:4,
Nagawara Main Rd, Bengaluru, Karnataka 560045
KARNATAKA
560045
India |
| Phone |
9900122287 |
| Fax |
|
| Email |
chethan.sadanand@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chethan S Sadanand |
| Designation |
Ophthalmic Surgeon |
| Affiliation |
Chethana Eye Care Centre |
| Address |
Chethana Eye Care Centre
1st Floor, Room No:4,
Nagawara Main Rd, Bengaluru, Karnataka 560045
KARNATAKA
560045
India |
| Phone |
9900122287 |
| Fax |
|
| Email |
chethan.sadanand@gmail.com |
|
|
Source of Monetary or Material Support
|
| Amanta Healthcare Limited, Plot No. 876, N.H. No. 8, Vill.: Hariyala,
Tal.: Matar, Dist.: Kheda - 387 411, Gujarat, India |
|
|
Primary Sponsor
|
| Name |
Amanta Healthcare Limited |
| Address |
Plot No. 876, N.H. No. 8, Hariyala, Kheda - 387 411, Gujarat, India
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Chethan S Sadanand |
Chethana Eye Care Centre |
Chethana Eye Care Centre
1st Floor, Room No:4,
Nagawara Main Rd, Bengaluru, Karnataka 560045
Bangalore
KARNATAKA |
9900122287
chethan.sadanand@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ACE Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H579||Unspecified disorder of eye and adnexa, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Sterile Hydroxy Propyl Methyl Cellulose (HPMC) Eye Drops |
Sterile Hydroxy Propyl Methyl Cellulose (HPMC) Eye Drops, is an artificial tear used to relieve dry eye conditions (e.g. conditions associated with the use of VDUs and TVs, infrequent blinking, certain medical treatments, atmospheric pollution and drying atmospheres e.g. air-conditioning, central heating, wind and sun). It is also used to moisten hard contact lenses and to lubricate artificial eyes.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Subjects who are able to give voluntary, written informed consent to participate in this study.
Subjects who experience as eye dryness, eye soreness/ burning, irritative sensation, eye fatigue, contact lens caused dryness, discomfort of eyes due to the continuous use of computer/ TV/ exposed pollution/ dry environment.
|
|
| ExclusionCriteria |
| Details |
Anyone with known allergic reaction to Sterile Hydroxy Propyl Methyl Cellulose Eye Drops.
Subjects with existing eye infection.
History of ocular surgery. History or active signs of severe or serious ocular conditions such as inflammatory corneal ulcers, recurrent erosions, and uveitis at any time
Patients participating in any another clinical trial during study
Pregnant/lactating women during study period. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
The primary objective will be, to confirm clinical safety and performance of the product Sterile Hydroxy Propyl Methyl Cellulose Eye Drops from the baseline with follow up visits.
|
1st Visit - After 8 days of using the product
2nd Visit - After one month of using the product
3rd Visit - After two months of using the product
4th Visit - After three months of using the product
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary objective will be to assess clinical benefits, contraindications and possible misuse/ off-label use during the use of the product. Also, the continued acceptability of benefit-risk ratio will be ensured during the study. Overall subject and PI satisfaction will be recorded in the case report form. |
1st Visit - After 8 days of using the product
2nd Visit - After one month of using the product
3rd Visit - After two months of using the product
4th Visit - After three months of using the product |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
Final Enrollment numbers achieved (Total)= "65"
Final Enrollment numbers achieved (India)="65" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
29/02/2024 |
| Date of Study Completion (India) |
04/06/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
This study will be an open-label, single-armed, single-centric, observational, prospective PMCF study. The subjects visiting the study centre with the complaints such as eye dryness, eye soreness/ burning, irritative sensation, eye fatigue, contact lens caused dryness, discomfort of eyes due to the continuous use of computer/TV/exposed pollution/dry environment will be screened on Day 0 and if they meet the inclusion and exclusion criteria, then they will be selected for the study. A total of 64 subjects will be recruited for this study, subjects will be undergoing visual acuity test, IOP, corneal staining, Superficial Keratitis, TBUT test, Schirmer’s test. After the consent is signed these subjects will be given Sterile Hydroxy Propyl Methyl Cellulose Eye Drops. The allocation of Sterile Hydroxy Propyl Methyl Cellulose Eye Drops will be subjected to eye dryness by the PI. They will be followed up for 4 times on Day 8th, Day 30th, Day 60th and Day 90th after using the product. At every follow up visit the above-mentioned test, comprehensive eye examination by the Investigator will be performed and apart from these performance and safety tests, benefits, risks, side effects and adverse events will be recorded.
Results-
This prospective, observational, single-centre PMCF study evaluated the safety and performance of Sterile Hydroxy Propyl Methyl Cellulose Eye Drops in 65 subjects, followed up on Day 8, 30, 60, and 90. Assessments included visual acuity, IOP, corneal staining, Schirmer’s test, and TBUT. Results showed no significant changes in visual acuity or IOP, and all subjects maintained normal corneal staining throughout. Statistically significant improvements were observed in both Schirmer’s test and TBUT (p=0.000 for both eyes), confirming enhanced eye moisture and tear film stability. Overall visual comfort and performance improved, with no clinical complications, adverse events, or residual risks reported, demonstrating that the product is safe, effective, and well tolerated with a favorable benefit–risk profile.
|