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Long-Term Safety and Tolerability of NOV03 (Perfluorohexyloctane) in Subjects Who Completed Trial NVU-003 (Kalahari Study)

Sponsor
Bausch & Lomb Incorporated (Industry)
Overall Status
Completed
CT.gov ID
NCT04140227
Collaborator
(none)
209
Enrollment
28
Locations
1
Arm
15.4
Actual Duration (Months)
7.5
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The objectives of this trial are to evaluate the safety and tolerability of perfluorohexyloctane (NOV03) ophthalmic solution during long-term use in subjects with Dry Eye Disease (DED) associated with MGD (Meibomian Gland Dysfunction).

Further objective is to evaluate the efficacy of perfluorohexyloctane (NOV03) solution during long-term use in subjects with DED associated with MGD.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
209 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 3, Multi-Center, Open-Label, Single-Arm Extension Clinical Trial to Assess the Extended Long-Term Safety and Tolerability of NOV03 (Perfluorohexyloctane) in Subjects Who Completed Trial NVU-003 (Kalahari Study)
Actual Study Start Date :
Sep 24, 2020
Actual Primary Completion Date :
Jan 5, 2022
Actual Study Completion Date :
Jan 5, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: NOV03 4 times daily (QID)

100% Perfluorohexyloctance solution 4 times daily (QID)

Drug: NOV03
100% Perfluorohexyloctane

Outcome Measures

Primary Outcome Measures

  1. Ocular and non-ocular adverse events [12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Signed ICF (Informed Consent Form)

  • Subject-reported history of Drye Eye Disease (DED) in both eyes

  • Ability and willingness to follow instructions, including participation in all study assessments and visits

Exclusion Criteria:

  • Women who are pregnant, nursing or planning pregnancy

  • Unwillingness to submit a blood pregnancy test at screening and the last visit (or early termination visit) if of childbearing potential, or unwillingness to use acceptable means of birth control

  • Clinically significant slit-lamp findings or abnormal lid anatomy at screening

  • Ocular/peri-ocular malignancy

  • History of herpetic keratitis

  • Active ocular allergies or ocular allergies that are expected to be active during the study

  • Ongoing ocular or systemic infection

  • Wear contact lenses within 1 month prior to screening or anticipated use of contact lenses during the study

  • Intra-ocular surgery or ocular laser surgery within the previous 6 months, or have planned ocular and/or lid surgeries over the study period

  • Presence of uncontrolled systemic diseases

  • Presence of known allergy and/or sensitivity to the study drug or saline components

  • Use of any topical steroids treatments, topical cyclosporine, lifitegrast, serum tears or topical anti-glaucoma medication within 2 months prior to screening

Contacts and Locations

Locations

Site City State Country Postal Code
1 Bausch Site 124 Birmingham Alabama United States 35233
2 Bausch Site 125 Scottsdale Arizona United States 85254
3 Bausch Site 110 Glendale California United States 91204
4 Bausch Site 121 Long Beach California United States 90805
5 Bausch Site 102 Mission Hills California United States 91345
6 Bausch Site 101 Newport Beach California United States 92663
7 Bausch Site 116 Rancho Cordova California United States 95670
8 Bausch Site 103 Torrance California United States 90505
9 Bausch Site 123 Torrance California United States 90505
10 Bausch Site 127 Danbury Connecticut United States 06810
11 Bausch Site 129 Fort Myers Florida United States 33901
12 Bausch Site 115 Jacksonville Florida United States 32256
13 Bausch Site 106 Largo Florida United States 33773
14 Bausch Site 117 Tampa Florida United States 33603
15 Bausch Site 108 Lake Villa Illinois United States 60046
16 Bausch Site 112 Indianapolis Indiana United States 46260
17 Bausch Site 119 Edgewood Kentucky United States 41017
18 Bausch Site 126 Winchester Massachusetts United States 01890
19 Bausch Site 113 Kansas City Missouri United States 64111
20 Bausch Site 111 Saint Louis Missouri United States 63131
21 Bausch Site 128 Slingerlands New York United States 12159
22 Bausch Site 114 Raleigh North Carolina United States 27603
23 Bausch Site 122 Cranberry Township Pennsylvania United States 16066
24 Bausch Site 107 Memphis Tennessee United States 38119
25 Bausch Site 109 Nashville Tennessee United States 37205
26 Bausch Site 120 El Paso Texas United States 79902
27 Bausch Site 104 Lakeway Texas United States 78738
28 Bausch Site 118 San Antonio Texas United States 78229

Sponsors and Collaborators

  • Bausch & Lomb Incorporated

Investigators

  • Study Director: Johnson Varughese, Bausch Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT04140227
Other Study ID Numbers:
  • NVU-004 (Kalahari)
First Posted:
Oct 25, 2019
Last Update Posted:
Jan 19, 2022
Last Verified:
Jan 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Dry Eye Syndromes
Eye Diseases
Keratoconjunctivitis Sicca

Study Results

No Results Posted as of Jan 19, 2022