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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05723770
Other study ID # 922
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date August 14, 2023
Est. completion date December 23, 2023

Study information

Verified date March 2024
Source Bausch & Lomb Incorporated
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Determine the effect of a single instillation of NOV03 on the thickness and evaporation rate of the mucus-aqueous layer of the tear film


Description:

Characterize the effect of a single instillation of NOV03 on the lipid layer of the tear film


Recruitment information / eligibility

Status Completed
Enrollment 27
Est. completion date December 23, 2023
Est. primary completion date December 23, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: General/Ocular Inclusion Criteria 1. Will be at least 18 years of age at the time of consent. 2. Able to provide written voluntary informed consent. 3. Have a subject-reported history of DED in both eyes for at least 6 months prior to Visit 1. 4. Have Tear film break-up time (TFBUT) =5 sec at Visit - Have Ocular Surface Disease Index (OSDI) =25 at Visit 1. - Have an unanesthetized Schirmer's Test I =5 mm at Visit 1. - Have Meibomian Gland Dysfunction (MGD) defined as total MGD score = 3 (secretion of 5 central glands on lower eyelid will be evaluated, each will be scored from 0-3; 0 = normal, 1 = thick/yellow, whitish, particulate 2 = paste; 3 = none/occluded; total score will range from 0-15) at Visit 1. - Have a total corneal fluorescein staining score of =2 and =11 (i.e. sum of inferior, superior, central, nasal, and temporal) according to the National Eye Institute (NEI) scale at Visit 1. - Have at least one eye that satisfies all criteria for 4-8 above at Visit 1. - Is able to fix his/her gaze for a minute, i.e. can see the fixation target and with no nystagmus - Is able and willing to follow instructions, including participation in all trial assessments and visits. Exclusion Criteria: General/Ocular Exclusion Criteria 1. Have any clinically significant ocular surface slit-lamp findings at Visit 1 and Visit 2 and/or in the opinion of the Investigator had any findings that may have interfered with trial parameters, including 1. history of eye trauma 2. history of Stevens-Johnson syndrome 3. active blepharitis or lid margin inflammation 4. DED secondary to scarring, irradiation, alkali burns, cicatricial pemphigoid, or destruction of conjunctival goblet cells (as with vitamin A deficiency). 5. abnormal lid anatomy that caused incomplete eyelid closure 6. abnormal cornea shape (keratoconus) 7. corneal epithelial defect or significant confluent staining or filaments 8. history of herpetic keratitis. 9. has a pterygium in either eye. 10. ocular or periocular rosacea that in the judgement of the Investigator interfered with the trial 2. Has used any topical ocular steroids treatments, prescription dry eye therapy including varenicline nasal spray, or topical anti-glaucoma medication within 60 days prior to Visit 1. 3. Have had a LipiFlow procedure, intense pulse light procedure or any kind of other procedure affecting meibomian glands within 6 months prior to Visit 2. 4. Have received or removed a permanent punctum plug within 3 months (6 months for dissolvable punctum plugs) prior to Visit 2. 5. Have used any eye drops (prescription or artificial tears) and/or TrueTearTM device (intranasal tear neurostimulator) within 24 hours before Visit 2. 6. Have active ocular allergies or ocular allergies that are expected to be active during the trial period. 7. Have worn contact lenses within 1 month of Visit 1 or anticipate using contact lenses during the trial. 8. Have undergone intraocular surgery or ocular laser surgery within the previous 6 months or had any planned ocular and/or lid surgeries over the trial period. 9. Have an active ocular or systemic infection (bacterial, viral, or fungal), including fever requiring treatment with antibiotics. 10. Is a woman who was pregnant, nursing or planning a pregnancy. 11. Is a woman of childbearing potential who is not using an acceptable means of birth control; acceptable methods of contraception included: hormonal (oral, implantable, injectable, or transdermal contraceptives); mechanical (spermicide in conjunction with a barrier such as a diaphragm or condom); intrauterine device; or surgical sterilization of partner. For non-sexually active females, abstinence could have been regarded as an adequate method of birth control; however, if the subject becomes sexually active during the trial, she must agree to use adequate birth control as defined above for the remainder of the trial. 12. Has an uncontrolled systemic disease in the opinion of the Investigator will interfere with the trial. 13. Has a known allergy and/or sensitivity to the investigational drug. 14. Has used any oral medications known to cause ocular drying (e.g., antihistamines, antidepressants, etc.) on a non-stable regimen within 1 month prior to Visit 1 or is expected to be unstable during the trial. 15. Have taken isotretinoin (e.g. Accutane, Myorisan, Claravis, Amnesteem) within 6 months of Visit 1. 16. Has corrected VA worse than or equal to logarithm of the minimum angle of resolution (LogMAR), +0.7 as assessed with Early Treatment Diabetic Retinopathy Study (ETDRS) charts in both eyes at Visit 1. 17. Is currently enrolled in an investigational drug or device study or had used an investigational drug or device within 60 days of Visit 2.

Study Design


Intervention

Drug:
instillation of NOV03
This trial consists of 2 office visits over a period of approximately 2 weeks. At Visit 2, a designated clinical staff member or the investigator will instill 1 drop of NOV03 into each eye.

Locations

Country Name City State
United States Site 101 Miami Florida

Sponsors (1)

Lead Sponsor Collaborator
Bausch & Lomb Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Thickness of the mucus-aqueous tear film layer Thickness of the mucus-aqueous layer of the tear film, measured in nanometers over 4 hours following instillation of NOV03
Primary Thinning rate of the mucus-aqueous tear film layer The rate of change in the thickness of the tear film mucus-aqueous layer, measured in nanometers/second over 4 hours following instillation of NOV03
See also
  Status Clinical Trial Phase
Completed NCT04140227 - Long-Term Safety and Tolerability of NOV03 (Perfluorohexyloctane) in Subjects Who Completed Trial NVU-003 (Kalahari Study) Phase 3
Completed NCT04393441 - Efficacy and Safety of a New Artificial Tear Formulation Compared With Systane Ultra Multidose in Participants With Dry Eye Disease Phase 3
Completed NCT04036292 - Evaluation of the Efficacy and Safety of OC-01 Nasal Spray on Signs and Symptoms of Dry Eye Disease Phase 3
Completed NCT04139798 - Perfluorohexylcotane (NOV03) for the Treatment of Signs and Symptoms of Dry Eye Disease Associated With Meibomian Gland Dysfunction (Gobi Study) Phase 3
Completed NCT04523142 - CyclASol for the Treatment of Signs and Symptoms of Dry Eye Disease in Subjects Who Completed CYS-004 Phase 3
Completed NCT03333057 - Perfluorohexyloctane (NOV03) for the Treatment of Signs and Symptoms of Dry Eye Disease (DED) Phase 2
Completed NCT01998802 - Phase 3 Study of EBI-005 in Dry Eye Disease Phase 3