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A 2 Weeks Study to Evaluate Tolerability, Safety, Permanence on the Ocular Surface and Efficacy of Two Concentrations of Lubricin Eye Drops Versus Sodium Hyaluronate 0.18% Eye Drops in Patients With Ocular Discomfort Following Refractive Surgery

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ClinicalTrials.gov Identifier: NCT03031327
Recruitment Status : Completed
First Posted : January 25, 2017
Last Update Posted : July 26, 2018
Sponsor:
Information provided by (Responsible Party):
Dompé Farmaceutici S.p.A

Brief Summary:

A 2 week randomized (1:1:1), controlled, double-masked, parallel group, pre-market study.

Patients with ocular discomfort following refractive surgery procedure (within 6 months from enrollment into the investigation) will be evaluated at baseline (Day 1), at Week 2 (day 15±2 days) and at Week 3 follow-up visit (day 22±2, or early exit).


Condition or disease Intervention/treatment Phase
Ocular Discomfort Device: Lubricin 20µg/ml eye drops Device: Lubricin 50µg/ml eye drops Device: Sodium hyaluronate (HA) 0.18% eye drops Not Applicable

Detailed Description:

Thirty (30) patients (10 per arm) randomized 1:1:1 to Lubricin 20 µg/ml eye drops solution or Lubricin 50 µg/ml eye drops solution or sodium hyaluronate (HA) 0.18% eye drops solution will be enrolled.

As the primary objective of this study is to evaluate the tolerability and safety of Lubricin (20 and 50 μg/mL) eye drops solution administered over 2 weeks in patients with ocular discomfort following ocular refractive surgery, sample size was calculated based on clinical feasibility and no formal sample size calculation has been performed.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A 2 Week, Randomized, Double-masked, Controlled, Parallel Group Study to Evaluate Tolerability, Safety, Permanence on the Ocular Surface and Efficacy of Two Concentrations of Lubricin (20 and 50 μg/mL) Eye Drops Versus Sodium Hyaluronate (HA) 0.18% Eye Drops (Vismed®) in Patients With Ocular Discomfort Following Refractive Surgery
Actual Study Start Date : June 17, 2017
Actual Primary Completion Date : August 10, 2017
Actual Study Completion Date : August 10, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Lubricin 20µg/ml eye drops
Lubricin 20µg/ml eye drops 3 times per day
Device: Lubricin 20µg/ml eye drops
Lubricin 20µg/ml eye drops 3 times per day

Experimental: Lubricin 50µg/ml eye drops
Lubricin 50µg/ml eye drops 3 times per day
Device: Lubricin 50µg/ml eye drops
Lubricin 50µg/ml eye drops 3 times per day

Active Comparator: Sodium hyaluronate (HA) 0.18% eye drops
Sodium hyaluronate (HA) 0.18% eye drops 3 times per day
Device: Sodium hyaluronate (HA) 0.18% eye drops
Sodium hyaluronate (HA) 0.18% eye drops 3 times per day




Primary Outcome Measures :
  1. Tolerability using a Visual analogue scale (VAS) [ Time Frame: Day 1 ]
    Tolerability using a Visual analogue scale (VAS) for dryness, foreign body sensation, burning/stinging, itching, pain, stick feeling, blurred vision and photophobia

  2. Tolerability using a Visual analogue scale (VAS) [ Time Frame: Day 15 ]
    Tolerability using a Visual analogue scale (VAS) for dryness, foreign body sensation, burning/stinging, itching, pain, stick feeling, blurred vision and photophobia

  3. Tolerability using a Visual analogue scale (VAS) [ Time Frame: Day 22 ]
    Tolerability using a Visual analogue scale (VAS) for dryness, foreign body sensation, burning/stinging, itching, pain, stick feeling, blurred vision and photophobia

  4. Treatment-emergent adverse events (TEAEs) [ Time Frame: Day 1 ]
  5. Treatment-emergent adverse events (TEAEs) [ Time Frame: Day 15 ]
  6. Treatment-emergent adverse events (TEAEs) [ Time Frame: Day 22 ]

Secondary Outcome Measures :
  1. Ocular surface vital staining with Fluorescein (Oxford scale) [ Time Frame: Day 1 ]
  2. Ocular surface vital staining with Fluorescein (Oxford scale) [ Time Frame: Day 15 ]
  3. Ocular surface vital staining with Fluorescein (Oxford scale) [ Time Frame: Day 22 ]
  4. Schirmer-I test (without anaesthesia) [ Time Frame: Day 1 ]
  5. Schirmer-I test (without anaesthesia) [ Time Frame: Day 15 ]
  6. Schirmer-I test (without anaesthesia) [ Time Frame: Day 22 ]
  7. Permanence of Lubricin on the Ocular Surface [ Time Frame: Day 1 - 15 minutes - 30 minutes ]
  8. Permanence of Lubricin on the Ocular Surface [ Time Frame: Day 15 - 15 minutes - 30 minutes ]
  9. Permanence of Lubricin on the Ocular Surface [ Time Frame: Day 22 - 15 minutes - 30 minutes ]
  10. Tear film break-up time (TFBUT) [ Time Frame: Day 1 ]
  11. Tear film break-up time (TFBUT) [ Time Frame: Day 15 ]
  12. Tear film break-up time (TFBUT) [ Time Frame: Day 22 ]
  13. Best corrected distance visual acuity [ Time Frame: Day 1 ]
  14. Best corrected distance visual acuity [ Time Frame: Day 15 ]
  15. Best corrected distance visual acuity [ Time Frame: Day 22 ]
  16. SANDE questionnaire scores - discomfort improvement entity [ Time Frame: Day 1 ]
  17. SANDE questionnaire scores - discomfort improvement entity [ Time Frame: Day 15 ]
  18. SANDE questionnaire scores - discomfort improvement entity [ Time Frame: Day 22 ]
  19. SANDE questionnaire scores - discomfort improvement speed [ Time Frame: Day 1 ]
  20. SANDE questionnaire scores - discomfort improvement speed [ Time Frame: Day 15 ]
  21. SANDE questionnaire scores - discomfort improvement speed [ Time Frame: Day 22 ]
  22. Signs evaluated by Slit lamp examination (SLE) [ Time Frame: Day 1 ]
    blepharitis, eyelid hyperemia/oedema, lashes, conjunctiva hyperemia

  23. Signs evaluated by Slit lamp examination (SLE) [ Time Frame: Day 15 ]
    blepharitis, eyelid hyperemia/oedema, lashes, conjunctiva hyperemia

  24. Signs evaluated by Slit lamp examination (SLE) [ Time Frame: Day 22 ]
    blepharitis, eyelid hyperemia/oedema, lashes, conjunctiva hyperemia

  25. Intraocular pressure [ Time Frame: Day 1 ]
  26. Intraocular pressure [ Time Frame: Day 15 ]
  27. Intraocular pressure [ Time Frame: Day 22 ]
  28. Corneal sensitivity by Cochet-Bonnet aesthesiometry [ Time Frame: Day 1 ]
  29. Corneal sensitivity by Cochet-Bonnet aesthesiometry [ Time Frame: Day 15 ]
  30. Corneal sensitivity by Cochet-Bonnet aesthesiometry [ Time Frame: Day 22 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients 18 years of age or older.
  2. Patients undergone ocular refractive surgery within 6 months from Day 1 Visit.
  3. Patients with ocular discomfort defined as SANDE score ≥ 30 at baseline.
  4. Average VAS score (dryness, foreign body sensation, burning/stinging, itching, pain, stick feeling, blurred vision and photophobia) ≥ 25 mm;
  5. Best corrected distance visual acuity (BCDVA) score ≥ 0.1 decimal units in both eyes at the time of study enrolment.
  6. Only patients who satisfy all Informed Consent requirements may be included in the study. The patient and/or his/her legal representative must read, sign and date the Informed Consent document before any study-related procedures are performed. The Informed Consent form signed by patients and/or legal representative must have been approved by the Ethics Committee for the current study.

Exclusion Criteria:

  1. Patients with a severe Dry Eye condition (severity level 4 according to the Report of the International Dry Eye Workshop -DEWS, 2007)
  2. Best corrected distance visual acuity (BCDVA) score of < 0.1 decimal units in either eye at the time of study enrolment
  3. Evidence of an active ocular infection in either eye
  4. History or presence of ocular surface disorders other than ocular discomfort in either eye
  5. Use of any ocular topical medication other than the study medications for the treatment of ocular diseases including artificial tears during the study period
  6. Use of topical cyclosporine, topical corticosteroids or any other topical medication for the treatment of dry eye in either eye within 30 days of study enrolment
  7. History of any ocular surgery (excluding laser or refractive surgical procedures) in either eye within 30 days before study enrolment. Ocular surgery will not be allowed during the study treatment period and elective ocular surgery procedures should not be planned during the duration of the follow-up period
  8. Known hypersensitivity to one of the components of the study or procedural medications
  9. Participation in another clinical study at the same time as the present study or within 90 days of screening/baseline visit
  10. History of drug, medication or alcohol abuse or addiction.
  11. Females of childbearing potential (those who are not surgically sterilized or post-menopausal for at least 1 year) are excluded from participation in the study if they meet any one of the following conditions:

    1. are currently pregnant or,
    2. have a positive result on the urine pregnancy test at the Screening/Baseline Visit or,
    3. intend to become pregnant during the study treatment period or,
    4. are breast-feeding or,
    5. not willing to use highly effective birth control measures, such as: Hormonal contraceptives - oral, implanted, transdermal, or injected and/or mechanical barrier methods - spermicide in conjunction with a barrier such as a condom or diaphragm or IUD (intrauterine device ) during the entire course of and 30 days after the study treatment periods.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03031327


Locations
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Italy
Università La Sapienza- Policlinico Umberto I
Rome, Italy, 00161
Sponsors and Collaborators
Dompé Farmaceutici S.p.A
Investigators
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Principal Investigator: Alessandro Lambiase, MD, PhD Università La Sapienza- Policlinico Umberto I - Rome
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Responsible Party: Dompé Farmaceutici S.p.A
ClinicalTrials.gov Identifier: NCT03031327    
Other Study ID Numbers: LUB0116MD
First Posted: January 25, 2017    Key Record Dates
Last Update Posted: July 26, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dompé Farmaceutici S.p.A:
Ocular Discomfort Following Refractive Surgery
Refractive Surgery
Additional relevant MeSH terms:
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Ophthalmic Solutions
Hyaluronic Acid
Pharmaceutical Solutions
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents