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Keratoconjunctivitis Sicca

16
Pipeline Programs
17
Companies
15
Clinical Trials
0
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
0
0
8
0
8
0
Early DiscoveryClinical DevelopmentMarket

Competitive Landscape

16 companies ranked by most advanced pipeline stage

Sandoz
SandozAustria - Kundl
3 programs
1
2
RebamipidePhase 3
RebamipidePhase 3
PimecrolimusPhase 21 trial
Active Trials
NCT00128245Completed440Est. Dec 2006
Otsuka
OtsukaJapan - Tokushima
3 programs
1
2
RebamipidePhase 31 trial
RebamipidePhase 31 trial
rebamipide 2% ophthalmic suspensionPhase 21 trial
Active Trials
NCT01057147Completed116Est. Feb 2011
NCT00201981Completed740Est. Feb 2007
NCT00201955Completed740Est. Jul 2006
AbbVie
AbbVieNORTH CHICAGO, IL
2 programs
1
Ophthalmic EmulsionPhase 31 trial
cyclosporine ophthalmic emulsion 0.05%, artificial tearsN/A1 trial
Active Trials
NCT00717418Completed781Est. Aug 2008
NCT00025818Completed290Est. Mar 2003
Can-Fite BioPharma
Can-Fite BioPharmaIsrael - Petach Tikva
2 programs
1
1
CF101Phase 31 trial
CF101Phase 21 trial
Active Trials
NCT00349466Completed80Est. May 2009
NCT01235234Completed236Est. Dec 2013
MSD
MSDIreland - Ballydine
1 program
1
INS365 Ophthalmic SolutionPhase 31 trial
Active Trials
NCT00037661Completed222Est. Mar 2003
Sharp Therapeutics
Sharp TherapeuticsPA - Pittsburgh
1 program
1
INS365 Ophthalmic SolutionPhase 3
Bausch + Lomb
Bausch + LombNJ - Bridgewater
1 program
1
LotemaxPhase 2
Bausch Health
Bausch HealthQUEBEC, Quebec, Canada
1 program
1
LotemaxPhase 21 trial
Active Trials
NCT01817582Completed102Est. Jan 2014
Mitotech
MitotechUK - London
1 program
1
Low Dose 0.155µg/mL SkQ1 ophthalmic solutionPhase 21 trial
Active Trials
NCT02121301Completed91Est. Jun 2014
Kubota Vision
Kubota VisionJapan - Tokyo
1 program
1
rebamipide 2% ophthalmic suspensionPhase 2
Kubota Pharmaceutical
1 program
1
rebamipide 2% ophthalmic suspensionPhase 2
Novartis
NovartisBASEL, Switzerland
3 programs
PimecrolimusPHASE_2
RebamipidePHASE_3
RebamipidePHASE_3
Rigel Pharmaceuticals
Rigel PharmaceuticalsSOUTH SAN FRANCISCO, CA
2 programs
R348 Ophthalmic Solution, 0.2%PHASE_11 trial
R348 Ophthalmic Solution, 0.2%PHASE_21 trial
Active Trials
NCT01733992Completed36Est. Feb 2013
NCT01900249Completed204Est. Jul 2014
Medivis
MedivisNY - Brooklyn
1 program
Reinnerva/Lubristil +G sterile eye dropsN/A1 trial
Active Trials
NCT07422259Completed40Est. Sep 2025
Alcon
AlconFORT WORTH, TX
1 program
TearLab Core Validation Study to Establish Referent Values for Dry Eye DiseaseN/A1 trial
Active Trials
NCT00848198Completed314Est. Mar 2011
Merck & Co.
Merck & Co.RAHWAY, NJ
1 program
INS365 Ophthalmic SolutionPHASE_3

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
Can-Fite BioPharmaCF101
OtsukaRebamipide
OtsukaRebamipide
MSDINS365 Ophthalmic Solution
AbbVieOphthalmic Emulsion
MitotechLow Dose 0.155µg/mL SkQ1 ophthalmic solution
Rigel PharmaceuticalsR348 Ophthalmic Solution, 0.2%
Bausch HealthLotemax
Otsukarebamipide 2% ophthalmic suspension
Can-Fite BioPharmaCF101
SandozPimecrolimus
Rigel PharmaceuticalsR348 Ophthalmic Solution, 0.2%
MedivisReinnerva/Lubristil +G sterile eye drops
AlconTearLab Core Validation Study to Establish Referent Values for Dry Eye Disease
AbbViecyclosporine ophthalmic emulsion 0.05%, artificial tears

Clinical Trials (15)

Total enrollment: 4,432 patients across 15 trials

NCT01235234Can-Fite BioPharmaCF101

Trial of CF101 to Treat Patients With Dry Eye Disease

Start: Jul 2011Est. completion: Dec 2013236 patients
Phase 3Completed
NCT00201981OtsukaRebamipide

Study of Rebamipide Eye Drops to Treat Dry Eye

Start: May 2004Est. completion: Feb 2007740 patients
Phase 3Completed
NCT00201955OtsukaRebamipide

Study of Rebamipide Eye Drops to Treat Dry Eye

Start: May 2004Est. completion: Jul 2006740 patients
Phase 3Completed
NCT00037661MSDINS365 Ophthalmic Solution

Study of INS365 Ophthalmic Solution in a Controlled Adverse Environment in Patients With Dry Eye

Start: Apr 2002Est. completion: Mar 2003222 patients
Phase 3Completed
NCT00025818AbbVieOphthalmic Emulsion

Six Month Clinical Research Study for Patients With Moderate or Severe Dry Eye Syndrome

Start: May 2001Est. completion: Mar 2003290 patients
Phase 3Completed
NCT02121301MitotechLow Dose 0.155µg/mL SkQ1 ophthalmic solution

A Clinical Study to Assess the Safety and Efficacy of an Ophthalmic Solution (SkQ1) in the Treatment of Dry Eye Syndrome (DES)

Start: Apr 2014Est. completion: Jun 201491 patients
Phase 2Completed
NCT01900249Rigel PharmaceuticalsR348 Ophthalmic Solution, 0.2%

To Assess the Safety and Efficacy of R932348 Ophthalmic Solutions in Patients With Keratoconjunctivitis Sicca

Start: Jul 2013Est. completion: Jul 2014204 patients
Phase 2Completed
NCT01817582Bausch HealthLotemax

Lotemax® Gel 0.5% and Restasis 0.05% in Participants With Mild or Moderate Keratoconjunctivitis Sicca (Dry Eye Disease)

Start: May 2013Est. completion: Jan 2014102 patients
Phase 2Completed
NCT01057147Otsukarebamipide 2% ophthalmic suspension

Safety and Efficacy Study of Rebamipide 2% Ophthalmic Suspension in Subjects With Dry Eye - Effects on Central Cornea

Start: Feb 2010Est. completion: Feb 2011116 patients
Phase 2Completed
NCT00349466Can-Fite BioPharmaCF101

Safety and Efficacy Study of CF101 to Treat Keratoconjunctivitis Sicca

Start: Jan 2007Est. completion: May 200980 patients
Phase 2Completed
NCT00128245SandozPimecrolimus

Safety and Efficacy of Pimecrolimus Ophthalmic Suspension in Patients With Moderate to Severe Keratoconjunctivitis Sicca

Start: Sep 2004Est. completion: Dec 2006440 patients
Phase 2Completed
NCT01733992Rigel PharmaceuticalsR348 Ophthalmic Solution, 0.2%

A Safety, Tolerability and Pharmacokinetics Study of R932348 Eye Drops in Patients With Dry Eye Disease

Start: Nov 2012Est. completion: Feb 201336 patients
Phase 1Completed
NCT07422259MedivisReinnerva/Lubristil +G sterile eye drops

Tolerability and Efficacy Study of Reinnerva/Lubristil+G vs Vismed

Start: Jun 2025Est. completion: Sep 202540 patients
N/ACompleted
NCT00848198AlconTearLab Core Validation Study to Establish Referent Values for Dry Eye Disease

TearLab Core Validation Study to Establish Referent Values for Dry Eye Disease

Start: Feb 2009Est. completion: Mar 2011314 patients
N/ACompleted
NCT00717418AbbViecyclosporine ophthalmic emulsion 0.05%, artificial tears

Efficacy Study of Cyclosporine Ophthalmic Emulsion in Patients With Dry Eye Disease

Start: Sep 2004Est. completion: Aug 2008781 patients
N/ACompleted

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Phase Legend

Preclinical— Lab & animal studies
Phase 1— Safety & dosing
Phase 2— Efficacy testing
Phase 3— Large-scale trials
On Market— Approved & available

Key Insights

8 late-stage (Phase 3) programs, potential near-term approvals
17 companies competing in this space

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.