(1) ICD-10 Condition: H28||Cataract in diseases classified elsewhere,
Intervention / Comparator Agent
Type
Name
Details
Intervention
HPMC Ophthalmic Solution
Eye drops Soothes and gives comfort to the eyes.
It is recommended to use one or two drop into the eye (or eyes) affected by dryness. Many people find it is sufficient to use the drops three or four times a day, but it can be used as often as needed to if the eyes are very dry. If the drops have been prescribed then follow the directions given by the doctor. The eye drops should be applied to the affected eye following the instructions given below
To apply the eye drops:
•Instill one or two drops into each eye when required, or use as directed by your eye care practitioner.
•Blink several times.
•Replace the cap tightly after use.
The duration of intervention is 90 days
Comparator Agent
Not Applicable
Not Applicable
Inclusion Criteria
Age From
18.00 Year(s)
Age To
75.00 Year(s)
Gender
Both
Details
At the time of screening and usage of the product all subjects must meet the following criteria for inclusion into the study and the subjects will receive the prescribed eye drops from the PI/CO-PI by a medical practitioner. The inclusion criteria for the subjects for this study are as follows:
-Subjects who experience dryness, Itchiness, discomfort of eyes due to the continuous use of computer/TV/exposed pollution/dry environment
-Subjects wearing contact lenses who experience dryness, Itchiness, discomfort of eyes due to the continuous use of computer/TV/exposed pollution/dry environment
ExclusionCriteria
Details
The below Subjects are excluded from the study:
-Subjects who are not willing to participate in the study
-Anyone with known allergic reaction to HPMC eye drops
-Subjects with existing eye infection
-Subjects undergone recent (6 weeks) cataract surgery who are on other eye medication.
Method of Generating Random Sequence
Other
Method of Concealment
Not Applicable
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
The primary objective is to confirm clinical safety and performance of the product Hypromellose Ophthalmic Solution (eye drop) by performing a set of eye examinations (i.e. -visual acuity test, IOP measurement, corneal staining, TBUT test, Schirmers test) considering the baseline from the initial visits and data obtained from the follow up visits. If the end user is a contact lens wearer contact lens characteristics will also be measured at the end of the study.
Subjects will be followed-up for 4 times after the product use which is on Day 8th, Day 30th, Day 60th and Day 90th. At every follow up visit screening test, comprehensive eye examination by the Investigator will be performed and apart from these tests the product performance, safety, benefits, risks, satisfaction, changes observed in the eye dryness, side effects, and adverse device effect will be checked by asking the quantitative questions from the case report form.
Secondary Outcome
Outcome
TimePoints
The secondary objective is to assess any emerging undesirable events along with monitoring of desired events, contraindications, residual risk, emerging risk under normal usage of the eye drops for prolonged period to ensure acceptability of benefit risk ratio of the Eye drop, which will be recorded in CRF during every follow up visit based on the subject rating. The study will be focused on identifying possible systematic misuse or off-label use of the device.
Subjects will be followed-up for 4 times after the product use which is on Day 8th, Day 30th, Day 60th and Day 90th. At every follow up visit screening test, comprehensive eye examination by the Investigator will be performed and apart from these tests the product performance, safety, benefits, risks, satisfaction, changes observed in the eye dryness, side effects, and adverse device effect will be checked by asking the quantitative questions from the case report form.
Target Sample Size
Total Sample Size="87" Sample Size from India="87" Final Enrollment numbers achieved (Total)= "87" Final Enrollment numbers achieved (India)="87"
A post market clinical follow up prospective study to evaluate safety and performance of Hypromellose Ophthalmic Solution.
HPMC Ophthalmic Solution is used to relieve eye discomfort and soreness due to environmental factors. They moisten, soothe and lubricate the surface of the eye, making it feel more comfortable. Hypromellose provides lubrication to the ocular surface and maintaining corneal hydration in dry eye conditions. The viscosity promoting properties of Hypromellose prolong the retention time and improve adhesion of synthetic tears to the cornea and conjunctiva.
Polyhexamethylene biguanide binds to the negatively charged phospholipids found in the microbial plasma membranes causing membrane disruption and cellular lysis. Hypromellose Ophthalmic Solution USP can be used to protect the eye from irritations/dryness/discomfort due to continuous use of computer/TV/exposed pollution/dry environment and use of contact lenses.
There will be 4 follow up visits expected after using the product:
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
Intended purpose
Persons who experience dryness, Itchiness, discomfort of eyes due to the continuous use ofcomputer/TV/exposed pollution/dry environment use the eye drops to soothe the eyes.
Intended users
Persons who experience dryness/itchiness/discomfort of eyes due to the continuous use of computer/TV/ exposed pollution /dry environment.
Results-
In this PMCF study, 88 subjects were screened (42 male, 46 female); one subject had a screen failure on Day 0 and another dropped out on Day 8 due to irritation. The population included patients with eye irritation, dryness, redness, strain, and discomfort related to screen use, pollution, or dry environments. The study was conducted at Marigold Hospital, Bangalore, using Hypromellose Ophthalmic Solution. Overall, the product was well tolerated, with only mild, transient adverse events (1 subject with irritation and 2 with discomfort), and no major safety issues were observed. Intraocular pressure, corneal staining, UNDVA, and BCDVA values remained within normal ranges, with only minor statistical differences by gender or age that were not clinically relevant. Clinical performance outcomes showed improved comfort, soothing, moisture, and tear stability, supported by positive results in Schirmer’s test and TBUT. Contact lens parameters were unaffected, confirming compatibility. The benefits reported included eye comfort, relief from soreness/irritation, lubricating and moisturizing effect, with relief lasting 2–5 hours. Both subjects and the PI rated satisfaction highly, with 84 subjects rating good and 2 moderate. Overall, the benefit–risk ratio was favorable, demonstrating that Hypromellose Ophthalmic Solution is safe, effective, and improves patient comfort and quality of vision.