Bilateral Blepharitis (Disorder) Clinical Trial
Official title:
Randomized, Controlled Study With a Closed Sequential Design to Compare the Efficacy, Safety and Patient Satisfaction of Blephapad Combo vs. Standard Treatment for Eyelid Cleansing in Patients Affected by Bilateral Posterior Blepharitis.
| Verified date | November 2019 |
| Source | NTC srl |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to evaluate the efficacy of, and patient satisfaction with Blephapad Combo in the treatment of posterior blepharitis.
| Status | Completed |
| Enrollment | 19 |
| Est. completion date | February 9, 2018 |
| Est. primary completion date | February 9, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 40 Years and older |
| Eligibility |
Inclusion Criteria: - Age > 40 years - Male or female - Diagnosis of bilateral posterior blepharitis - Written informed consent of patient Exclusion Criteria: - Treatment with topical ophthalmic drugs (artificial tears allowed) - Ocular surgery in the previous 6 months - Pregnant or breastfeeding women - Alcohol abuse - Psychiatric disorders - Cognitive impairment that could affect evaluation of preferences - Participation in other clinical studies in the last month - Hypersensitivity to one or more components of the study products |
| Country | Name | City | State |
|---|---|---|---|
| Italy | A.O.U. Policlinico Mater Domini | Catanzaro | CZ |
| Lead Sponsor | Collaborator |
|---|---|
| NTC srl |
Italy,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Incidence of Ocular Adverse Events Reported Throughout the Study | A targeted physical examination was performed at all visits and monitoring for ocular and systemic adverse events occurred throughout the study | From Visit 2 (baseline) to Visit 3 (week 4) | |
| Other | Compliance to Treatment Evaluated by Counting the Applications (Wet Wipes) to Each Eyes | Adherence to treatment was evaluated at Visit 3 by counting given wipes/gauze and unused/lost/damaged wipes/gauze. The compliance to treatment was evaluated by counting given wipes/gauze and unused/lost/damaged wipes/gauze. The following formula was applied: (Given wipes/gauze - (sum of unused/lost/damaged wipes/gauze)) / Expected number of wipes/gauze used) x 100. Where the "given wipes/gauze" were 60 and the "expected number of wipes/gauze used" were 2 per days per 4 weeks = 56. |
From Visit 2 (baseline) to Visit 3 (week 4) | |
| Primary | Percentage Change of the Total Score of the Grading Scales for Meibomian Gland Dysfunction (MGD) | The total score of the meibomian gland dysfunction (MGD) grading scale was automatically computed by the system as the sum of the six sub-scores (i.e. Lid margin findings of vascularity, Plugging of gland orifices, Lid margin irregularity, Lid margin thickening, Partial glands and Gland dropout), ranging from 0 to 15, where higher values rapresent a worse outcome. The first four parameters were evaluated using photographic images of anterior segments, while the last two were evaluated using infrared images of the meibomian glands Based on the percentage change from baseline to week 4 of the total score of MGD score, Investigators will choose which of the two eyes had a better change of clinical features. |
from baseline to week 4 | |
| Secondary | Change of the Total Score of the Grading Scales for Meibomian Gland Dysfunction (Improved vs Not Improved) | For each eye change from baseline to week 4 in the total score of Meibomian Gland Dysfunction was also expressed as one of the following outcomes: Eye on Blephapad Combo: Improved-Eye on Standard: Improved Eye on Blephapad Combo: Improved-Eye on Standard: NOT Improved Eye on Blephapad Combo: NOT Improved-Eye on Standard: Improved Eye on Blephapad Combo: NOT Improved-Eye on Standard: NOT Improved The total score was automatically computed by the system as the sum of the six sub-scores (i.e. Lid margin findings of vascularity, Plugging of gland orifices, Lid margin irregularity, Lid margin thickening, Partial glands and Gland dropout), ranging from 0 to 15 (higher values rapresent a worse outcome).If the change of the total score was positive or equal to 0 the specific eye was referred as "NOT improved",on the contrary if the change of the total score resulted negative the specific eye was referred as "Improved". For each patient the results on the two eyes were combined. |
From Visit 2 (baseline) to Visit 3 (week 4) | |
| Secondary | Number of Patients Preferring the Standard or the Study Treatment (i.e. Answers to a Specific Question on Patient Preference: Study Drug vs. Standard Treatment) | At the end of study patients was asked to state their preference on the treatments used. | at Visit 3 (week 4) |