Skip to main content
OpenTrials
Completed

NCT Number: NCT03833908

Evaluation of the Performance of MAF-1217 on Cataract Surgery

MAF-1217 is meant as the medical device which is to be effective in most forms of DED; therefore, it is expected that study patients benefit from study participation, and can reduce the signs and symptoms of surgery induced DED in patients undergoing cataract surgery, in a TID application pre-surgery.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Dry Eye Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Università di Firenze, Clinica Oculistica II,, Florence, Italy

Loading trial locations.

About this study

This is a multicentre, pre-market, open label, randomized, prospective study exploring the performance of MAF-1217 when administered pre-surgery, in reducing the sign and symptoms of post-surgery DED in patients undergoing cataract surgery. Patients will be enrolled 2 weeks before Surgery (screening visit), will undergo cataract surgery (Day 0 - Baseline/Surgery), and then will be seen at week 1 and 2 after surgery.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • At least 18 years old patients, male and female
  • Patients without diagnosed DED (including subclinical DED) or with mild DED, with BUT >7
  • Normal to mild DED according to OSDI chart
  • Diagnosis of Cataract requiring surgery
  • Wishing to participate in the study and able to sign the ICF
  • Shirmer test > 15 mm /5'
  • No topic ophthalmic medication, including lubricating eyedrops administration for at least 4 days before screening visit.

Exclusion criteria

  • Neuropathic causes of dry eye (diabetes, long-standing contact lens wearing, previous ocular herpes infections)
  • Patients with diagnosis of Glaucoma
  • Functional and anatomic eyelid abnormalities,
  • Complicated cataract,
  • Suture affixing during surgery,
  • Use of artificial tears in the month preceding the study visit
  • Coexisting corneal diseases
  • Autoimmune diseases
  • Past or active cicatricial conjunctivitis
  • Past ocular surface burns
  • Keratinization of the eyelid margin
  • Sjogren syndrome
  • History of corneal trauma
  • Pregnant and lactating women
  • Younger than 18 years old patients
  • Inability to self-administer study medications
  • Known allergic sensitivity to any of the devices ingredients, or any other type of allergy
  • Participation in a clinical trial during the 3 months prior to the beginning of the study

Treatment and study plan

MAF-1217

Device

Patients will be enrolled at screening (2 weeks before surgery), then will be randomized with a 1:1 ratio to 2 groups of 23 patients each: A. patients receiving MAF-1217 B. patients receiving just standard antibiotic therapy

Primary outcomes

  1. break-up time (BUT)

    Time frame: 1 month

    Difference in the change (with respect to the baseline/surgery visit, V0) in the two arms occurred in break-up time (BUT)

Secondary outcomes

  1. osmolarity

    Time frame: 1 month

    Difference in the change (with respect to the baseline/surgery visit, V0) in the two arms occurred in osmolarity

  2. OSDI score

    Time frame: 1 month

    Difference in the change (with respect to the baseline/surgery visit, V0) in the two arms occurred in OSDI score.

    The OSDI is assessed on a scale of 0 to 100, with higher scores representing greater disability. The index demonstrates sensitivity and specificity in distinguishing between normal subjects and patients with dry eye disease.

  3. Schirmer test I

    Time frame: 1 month

    Difference in the change (with respect to the baseline/surgery visit, V0) in the two arms occurred in Schirmer test I (test uses paper strips inserted into the eye for several minutes to measure the production of tears)

Sponsors and collaborators

Lead sponsor

VISUfarma SpA

Industry

Registry information

Official study title

Evaluation of the Performance of MAF-1217 on Surgery Induced DED When Administered Pre-operatively in Patients Undergoing Cataract Surgery

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 7, 2019
Registry last updated
Jul 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.