Health Condition 1: H105- Blepharoconjunctivitis
Conditions
Interventions
Intervention1: Posifomin® 2% eye ointment: Administer a strip of ointment POSIFORMIN 2% (about 5 mm) 3 times per day for 14 days.
Control Intervention1: Placebo: Administer a strip of ointment POSIFO
Sponsors
Ursapharm India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Written informed consent. 2. Ambulatory male and female patients >= 18 years of age 3. Diagnosis of a chronic blepharoconjunctivitis 4. Summarized score of signs and symptoms (sum score of severity of lid oedema, lid erythema, debris, hyperemia and pouting of Meibomian glands and additionally the patientâ??s assessment of ocular discomfort) of >= 18 at baseline.
Exclusion criteria
Exclusion criteria: Exclusion Criteria: 1. Ocular conditions: a. chronic blepharoconjunctivitis requiring antibiotic treatment therapy-resistant chronic blepharoconjunctivitis b. acute ocular and/or follicle- or lid- infection or active ocular inflammation other than blepharoconjunctivitis c. irritations of the outer eye that are related to corneal damage (e. g. erosions, injuries, burns) d. abnormal eye lid anatomy (other than due to chronic blepharoconjunctivitis) e. Ocular surgery within 90 days (trauma, intraocular surgery, refractive surgery, palpebral surgery (e.g. ectopium OP), etc.) f. severe dry eye syndrome also due to systemic diseases allergic eye disease Glaucoma IOP >= 21 mmHg (non-contact tonometry) changes in performance of lid hygiene during the trial 2. Systemic condition: a. known hypersensitivity to the investigational product or any of its ingredients b. severe systemic disease c. rheumatoid arthritis or spondylitis d. subjects with history of malignancy of any organ system, treated or untreated, within the past five years, whether or not evidence of local recurrence or metastases exists, are excluded 3. Concomitant medication: a. oral or topical antibiotics 2 weeks prior to and/ or during the trial b. any other ocular antiseptics during the trial c. topical ocular or systemic corticosteroids 2 weeks prior to and/ or during the trial (except chronic use of inhalative corticosteroids if on stable dose one month prior to and during the trial) d. topical ocular and systemic NSAIDs 2 weeks prior to and/ or during the trial (low dose oral acetylsalicylic acid and occasional use of painkillers is allowed) e. local ocular use of antihistamines one month and prior to and/ or during the trial f. ocular α-sympathomimetics one month and prior to and/ or during the trial 4. Other: a. any eye cosmetics during the trial b. patients who anticipate changes in their ongoing regimen of concurrent systemic therapies that could affect trial parameters c. wearing contact lenses during the trial d. pregnant or breast feeding women e. women with childbearing potential, not using a reliable and medically accepted method of contraception (no pregnancy test is required in women, being 2 years after menopause) f. any systemic or ocular medical or physical condition which, in the investigatorâ??s opinion, would preclude the participant from adhering to the protocol or completing the trial per protocol. g. patients participating in another clinical trial at the same time h. patients taking any investigational product 4 weeks prior to the trial i. patients already once included in the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Compare the effects of two weeks of treatment with Posifomin 2% eye ointment versus placebo: Reduction in signs and symptoms of chronic blepharoconjunctivitis, expressed as the change from baseline in the sum score which comprises severity of lid edema, lid erythema, debris, hyperemia and pouting of Meibomian glands, as assessed by the investigator on slit lamp examination. Timepoint: Compare the effects of two weeks of treatment with Investigational Product versus placebo | — |
Secondary
| Measure | Time frame |
|---|---|
| Compare the effects of two weeks of treatment with Posifomin 2% eye ointment versus placebo on the following items: â?¢ Changes between baseline and end of treatment assessed separately in: o Lid oedema (slit lamp examination) o Lid erythema (slit lamp examination) o Debris (slit lamp examination) o Hyperemia (slit lamp examination) o Pouting of Meibomian glands (slit lamp examination) â?¢ Ocular discomfort (assessed on VAS by the patients) â?¢ Safety endpoints: o ocular safety as measured by intraocular pressure and visual acuity o overall assessment of tolerability by the patient and investigator o frequency and number of drug related AEs/SAEs Timepoint: Compare the effects of two weeks of treatment with Investigational Product versus placebo | — |
Countries
India
Contacts
Public ContactDr Rajesh Jain
PharmaLex India PVT Ltd
Outcome results
None listed