Keratoconjunctivitis Sicca

7
Pipeline Programs
5
Companies
8
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
1
0
3
0
3
0
Early DiscoveryClinical DevelopmentMarket

Competitive Landscape

5 companies ranked by most advanced pipeline stage

Novartis
NovartisBASEL, Switzerland
3 programs
1
2
RebamipidePhase 31 trial
RebamipidePhase 31 trial
PimecrolimusPhase 21 trial
Active Trials
NCT00128245Completed440Est. Dec 2006
NCT00201955Completed740Est. Jul 2006
NCT00201981Completed740Est. Feb 2007
M&
Merck & Co.RAHWAY, NJ
1 program
1
INS365 Ophthalmic SolutionPhase 31 trial
Active Trials
NCT00037661Completed222Est. Mar 2003
Rigel Pharmaceuticals
Rigel PharmaceuticalsSOUTH SAN FRANCISCO, CA
2 programs
1
1
R348 Ophthalmic Solution, 0.2%Phase 21 trial
R348 Ophthalmic Solution, 0.2%Phase 11 trial
Active Trials
NCT01733992CompletedEst. Feb 2013
NCT01900249CompletedEst. Jul 2014
Bausch + Lomb
Bausch + LombNJ - Bridgewater
1 program
1
LotemaxPhase 21 trial
Active Trials
NCT01817582Completed102Est. Jan 2014
Alcon
AlconFORT WORTH, TX
1 program
TearLab Core Validation Study to Establish Referent Values for Dry Eye DiseaseN/A1 trial
Active Trials
NCT00848198CompletedEst. Mar 2011

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
NovartisRebamipide
NovartisRebamipide
Merck & Co.INS365 Ophthalmic Solution
Rigel PharmaceuticalsR348 Ophthalmic Solution, 0.2%
Bausch + LombLotemax
NovartisPimecrolimus
Rigel PharmaceuticalsR348 Ophthalmic Solution, 0.2%
AlconTearLab Core Validation Study to Establish Referent Values for Dry Eye Disease

Clinical Trials (8)

Total enrollment: 2,244 patients across 8 trials

NCT00201955NovartisRebamipide

Study of Rebamipide Eye Drops to Treat Dry Eye

Start: May 2004Est. completion: Jul 2006740 patients
Phase 3Completed
NCT00201981NovartisRebamipide

Study of Rebamipide Eye Drops to Treat Dry Eye

Start: May 2004Est. completion: Feb 2007740 patients
Phase 3Completed
NCT00037661Merck & Co.INS365 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
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 2014
Phase 2Completed
NCT01817582Bausch + LombLotemax

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
NCT00128245NovartisPimecrolimus

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 2013
Phase 1Completed
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 2011
N/ACompleted

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

3 late-stage (Phase 3) programs — potential near-term approvals
5 companies competing in this space