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`Brit. J. Ophthal. (1955), 39, 90.
`
`KERATO-CONJUNCTIVITIS SICCA TREATED WITH
`CORTISONE AND ACTH*
`BY
`STELLA EADIE AND MALCOLM THOMPSON
`Edinburgh
`
`THE effects of cortisone and ACTH in cases of kerato-conjunctivitis sicca
`(KCS) have been recorded by several authors (Table I).
`Reports of their
`value have been conflicting, probably because most observers only treated a
`single case, and because in several instances only limited supplies of the
`hormones were available, so that treatment may have been inadequate.
`TABLE I
`RESULTS OF TREATMENT BY CORTISONE AND ACTH ALREADY RECORDED
`
`Authors
`Offret and Forest
`Phillips
`Cristini
`Beiglbock and Hoff
`FerniAndez y Fernandes and
`Marafon
`Forestier and others
`Cadman and Robertson
`Cristini
`Sjogren and Eriksen
`Fitzgerald and others
`Stephens
`Forestier and others
`Frenkel and others
`Boume
`Phillips
`
`I
`
`Date
`1950, 1951
`1952
`1952
`1952
`
`1952
`1951
`
`1952
`1952
`1952
`1951
`1950
`1951
`1951
`
`1952
`1952
`
`No. of
`Cases
`
`Treatment
`
`1
`1
`1
`1
`
`I
`I
`
`2
`2
`4
`1
`1
`1
`i1
`
`11
`
`Cortisone
`
`ACTH
`
`Cortisone
`Eye Drops
`
`4
`
`Result
`Unchanged 2
`Unchangedf
`Improved
`Improved
`Improved J
`Improved
`Unchanged1
`Unchanged 9
`Unchanged
`Unchangedj
`Improved
`Improved
`Improved J
`Improved
`Improved f
`
`.3
`
`2
`
`The purpose of this paper is to report on twelve cases of kerato-conjunc-
`tivitis sicca treated with cortisone drops, systemic cortisone, or ACTH.
`The cortisone drops used were a 0-625 per cent. solution of cortisone acetate
`(Merck) in a buffered base, except where stated otherwise.
`*Rceived for publication August 20, 1954.
`90
`
`MYLAN - EXHIBIT 1054
`Mylan Pharmaceuticals Inc. et al. v. Allergan, Inc.
`IPR2016-01127, -01128, -01129, -01130, -01131, & -01132
`
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`91
`
`CORTISONE AND ACTH IN KERATO-CONJUNCTIVITIS SICCA
`Case Notes
`Case 1, a female aged 41 years, had had rheumatic fever in childhood with resultant
`mitral stenosis and aortic regurgitation.
`She had had rheumatoid arthritis for 28 years,
`latterly associated with KCS, xerostoma, salivary gland enlargement, and a persistent
`dry cough with small areas of pulmonary atelectasis and recurrent laryngitis. The ocular
`symptoms were relieved during a course of oral cortisone in December, 1951.
`An exacerbation of ocular symptoms occurred in October, 1952, when Schirmer's test
`gave 5 mm. in both eyes, and vision was 6/60 in the right eye, and 6/18 in the left.
`She
`was treated with cortisone drops three times daily and obtained relief within 48 hours.
`Staining was still
`In November, 1952, vision was 6/18 in the right eye and 6/5 in the left.
`present but less marked.
`In March, 1953, a course of Acthar gel relieved her arthritic and ocular symptoms.
`The parotid and submandibular swellings subsided.
`Schirmer's test was not significantly
`improved (8 mm. maximum). A relapse occurred on cessation of ACTH therapy (April,
`1953). The subsequent course is shown in Table II.
`TABLE II
`PROGRESS OF CASE 1
`
`Date of
`Exam-
`ination Symptoms Staining
`
`Right Eye
`Vision
`
`13.11.53
`
`6/36
`
`6/36
`
`0
`
`+++
`+++
`No treatment
`20.11.53 +++
`+++
`Cortisone drops 3-hrly
`±++
`+++
`6/12
`Cortisone drops three times daily
`+++
`6/24
`++
`Cortisone drops three times daily
`+++ 6/18+
`4
`++
`Hydrocortisone drops three times daily
`6/12
`0
`++
`Hydrocortisone drops three times daily
`0
`6/9pt.
`0
`++
`Hydrocortisone drops three times daily
`-
`6/9+
`0
`++
`Hydrocortisone drops three times daily
`+++ 6/9pt.
`2
`+
`Lacrimal puncta sealed
`0
`++
`
`27.11.53,
`
`11.12.53
`
`23.12.53
`
`8.1.54
`
`22.1.54
`
`14.2.54
`
`26.2.54
`
`31.5.54
`
`2
`
`0
`
`Left Eye
`Schirmer's Symptoms Staining
`Vision
`Test (mm.)
`+++
`+++
`2
`No treatment
`+++ I6/24pt.j
`+++
`Cortisone drops 3-hrly
`++
`+
`6/18+
`Cortisone drops three times daily
`6/18+
`+
`++
`Cortisone drops three times daily
`++v
`6/9
`+
`Cortisone drops three times daily
`0
`+++ 36/l2pt
`Cortisone drops three times daily
`+++ 6/18+
`0
`Cortisone drops three times daily
`0
`6/9 -
`++
`Cortisone drops three times daily
`+++ 6/9pt.,
`+
`
`Schirmer's
`Test (mm.)
`2
`
`6/36
`
`3
`
`4
`
`0
`
`3
`
`3
`
`3
`
`3
`
`6/6+
`
`5
`
`Nil
`
`++
`
`+++
`
`6/24
`
`5
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`92
`
`STELLA EADIE AND MALCOLM THOMPSON
`
`Case 2, a female aged 64 years, had had severe rheumatoid arthritis for 25 years, and
`Schirmer's test gave 3 mm. in both eyes.
`intermittent soreness of the eyes for 8 years.
`In March, 1953, vision was 6/18 in the right eye and 6/60 in the left.
`She was treated
`with cortisone drops three times daily, and in April, 1953, vision was 6/6 in the right eye
`and 6/36 in the left. When treatment was discontinued in July, 1953, she relapsed, but
`In November, 1953, while she was
`she improved again when treatment was resumed.
`still receiving drops, vision was 6/5 in the right eye and 6/9 in the left.
`Schirmer's test
`The subsequent
`showed 4 mm. in both eyes. The cortisone drops were then withdrawn.
`course is shown in Table III.
`
`TABLE III
`PROGRESS OF CASE 2
`
`Right Eye
`Date of
`Exam-
`ination Symptoms? Staining
`Vision
`
`Left Eye
`Schirmer's Symptoms Staining
`Vision
`Test (mm.)
`
`Schirmer's
`Test (mm.)
`
`+ +-+
`6/5
`Cortisone drops three times daily
`6/6pt.
`
`+ ++
`
`+
`
`+
`
`+
`
`+
`
`+++ 6/6pt.
`
`+++-I
`
`6/6pt.
`
`+++ 6/5pt.
`
`10.12.53
`
`15.12.53
`
`18.1.54
`
`9.2.54
`
`19.2.54
`
`25.3.54
`
`6.5.54
`
`21.5.54
`
`17.6.54
`
`Nil
`
`Nil
`
`Nil
`
`Nil
`
`Nil
`
`Nil
`
`5
`
`-+
`
`10
`
`6
`
`4
`
`0
`
`1
`
`-
`
`+-t+-+ 6/12
`iCortisone drops three times daily
`4 ++ 6/12+
`
`Nil
`
`Nil
`
`+
`
`-+
`
`6/12+
`
`4
`
`-
`
`10
`
`3
`
`8
`
`6/60
`-+ +
`+ ++
`Cortisone drops four times daily
`+X-+
`6/18
`+
`Cortisone drops four times daily
`+±
`6/18+
`+
`-
`Hydrocortisone drops four times daily
`6/36
`I
`
`+++
`+
`Lacrimal puncta sealed
`+±
`0
`Puncta still sealed
`-
`
`6/9
`
`6/6pt.
`
`4
`
`-
`
`0
`
`t-F+
`
`6/6
`
`! -
`
`+t
`
`+ +±
`
`6/6pt.
`
`+++ 6/6pt.
`++
`Cortisone drops three times daily
`Pt-.
`0
`
`Case 3, a female aged 47 years, had had xerostoma and inflamed eyes for 5 years, with
`no rheumatoid arthritis, but anaemia and achlorhydria. She obtained no relief from large
`doses of vitamins and oral iron, nor from antibiotic eye drops.
`In June, 1953, she had
`severe KCS; vision was 6/18 in the right eye and 6/9 + in the left.
`Treatment with
`cortisone drops three times a day gave symptomatic relief and the corneal staining
`Cortisone drops were discontinued in November, 1953. The subsequent
`decreased.
`course is shown in Table IV (opposite).
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`CORTISONE AND ACTH IN KERATO-CONJUNCTIVITIS SICCA
`TABLE IV
`PROGRESS OF CASE 3
`
`93
`
`Right Eye
`Date of
`Exam--
`ination Symptoms Staining
`Vision
`
`5.11.53
`
`+++
`
`6/18
`
`Left Eye
`Schirmer's Symptoms Staining
`Vision
`Test (mm.)
`2
`
`+++
`
`6/9
`
`+++
`Nil
`
`__
`Schirmer's
`Test (mm.)
`6
`
`+++
`Nil
`10.11.53 +++
`++++ 6/18pt.
`Intensive vitamin therapy
`+++ 6/24pt.
`2
`+++
`Cortisone drops 3-hrly for 2 days then
`four times daily
`++++ 6/18pt.
`++
`Cortisone drops four times daily
`+++ 6/24pt.
`++
`Lacrimal puncta sealed
`+++ 6/18+
`+
`Lacrimal puncta sealed
`+±
`6/12pt.
`+
`Lacrimal puncta re-sealed
`-
`0
`-
`Lacrimal puncta still sealed
`6/12pt.
`
`5.1.54
`
`19.1.54
`
`2.2.54
`
`16.2.54
`
`26.2.54
`
`13.3.54
`
`4.5.54
`
`+
`
`+
`
`0
`
`0
`
`0
`
`6
`
`2
`
`4
`
`6
`
`+++ 6/9pt.{
`+++
`Intensive vitamin therapy
`+++ 6/9pt.
`0
`+++
`Cortisone drops 3-hrly for 2 days then
`four times daily
`+-+
`6/9pt._
`+
`Cortisone drops four times daily
`+++
`6/12
`+
`Cortisone drops four times daily
`-++
`6/12+
`+
`Cortisone drops four times daily
`+++
`6/12+
`+
`Lacrimal puncta sealed
`-
`0
`Lacrimal puncta still sealed
`6/9pt.
`0
`
`0
`
`0
`
`0
`
`0
`
`0
`
`6
`
`6
`
`++
`
`Case 4, female aged 54 years, had had severe rheumatoid arthritis for 25 years, sore
`eyes intermittently for 18 months, xerostoma, and bilateral parotid swelling.
`In December,
`1953, the right eye was enucleated after perforation of a corneal ulcer. The left eye
`showed KCS, Schirmer's test gave 4 mm., and vision in the left eye was 6/12.
`Cortisone
`drops three times a day gave only slight subjective improvement. The staining and
`Schirmer's test did not improve and vision in the left eye deteriorated to 6/18.
`Cortisone
`In February, 1954, the left
`was instilled 5 times daily without further improvement.
`lacrimal puncta and canaliculi were sealed, giving marked symptomatic improvement.
`In May, 1954, the improvement was maintained, vision was 6/6, and Schirmer's test gave
`3 mm., but the corneal staining was still present.
`Case 5, female aged 44 years, had had rheumatoid arthritis for 22 years, recurrent
`Various eye drops had not given any relief.
`laryngitis, and inflamed eyes for one year.
`In February, 1954, vision was 6/18 in both eyes, KCS was present, and Schirmer's test
`gave 3 mm. in the right eye and I mm. in the left.
`Cortisone drops 1-5 per cent. solution
`were given four times a day to the right eye and hydrocortisone drops 1I5 per cent. solution
`After 2 weeks the symptoms in the right eye were
`four times a day to the left eye.
`relieved, but no improvement was seen in the left eye.
`Vision was 6/9 in the right eye
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`STELLA EADIE AND MALCOLM THOMPSON
`94
`94
`Later cortisone drops l 5 per cent. solution were given four
`and 6/24 in the left eye.
`times daily to both eyes, but there was no change in the condition of the left eye.
`Treatment was discontinued in April, 1954, and a full relapse occufred. In May, 1954,
`cortisone drops four times daily were combined with cortisone ointment applied to the eyes
`at night.
`After 2 weeks, the right eye had again responded but there was no improvement
`in the left eye.
`In June, 1954, the left lacrimal puncta were sealed and cortisone to the
`left eye was stopped.
`The eye improved with complete symptomatic relief and vision
`improved to 6/9.
`This improvement has been maintained.
`Case 6, a female aged 38 years, had had rheumatoid arthritis for 17 years, with Raynaud's
`disease, xerostoma, intermittent bilateral parotid swellings, recurrent laryngitis, and
`attacks of "conjunctivitis ".
`In November, 1954, she was thought to have KCS;
`Schirmer's test gave 0 mm. in the right eye and1
`mm. in the left eye.
`Vision was 6/9 in
`both eyes.
`Cortisone drops were given four times daily with marked subjective relief
`in both eyes and reduction of staining in the right. The cortisone was reduced to three
`times daily and the improvement was maintained.
`In January, 1954, 1 per cent. hydro-
`cortisone drops were given four times daily to the left eye and cortisone1
`per cent. four
`times daily to right eye.
`There was no further improvement in either eye.
`Case 7, a female aged 46 years, had had alopecia totalis since 1940, dry skin and trophic
`changes in the nails since 1946, xerostoma and dry cough since 1948, recurrently sore eyes
`since April, 1951, and severe sinusitis and rheumatoid arthritis since September, 1951.
`In February, 1952, she was given oral cortisone 100 mg. daily, with relief of ophthalmic
`Schirmer's test gave 8 mm. in
`symptoms and improvement in general condition.
`both eyes. The visual acuity was 6/6 in each eye. After one year of therapy, Schirmer's
`test gave 2 mm. in the right eye and 3 mm. in the left eye.
`Staining with rose bengal
`solution was present throughout.
`After 2 years of treatment, oral cortisone therapy was withdrawn during January, 1954,
`and the ocular symptoms recurred within a few days of withdrawal, with bilateral con-
`Cortisone eye-drops were given, and it was necessary to instil the
`junctival injection.
`drops 2-hourly to relieve the patient's symptoms completely.
`Schirmer's test continued
`to give 2 mm. in both eyes.
`Oral cortisone therapy, 75 mg. daily, was resumed in February, and this partially
`controlled the ocular and arthritic symptoms; when the dosage was increased to 100 mg.
`daily, the symptoms were completely relieved.
`Case 8, a female aged 66 years, had had severe rheumatoid arthritis for 4 years, and
`xerostoma and KCS for1
`year.
`In July, 1952, she was treated with cortisone eye-drops
`three times daily and chloramphemical eye ointment at night.
`Relief was obtained but
`the patient relapsed when the cortisone was stopped.
`In October, 1952, cortisone eye-
`drops were given to the left eye three times daily with marked symptomatic improvement.
`Case 9, female aged 59 years, had had rheumatoid arthritis for 13 years, recurrent attacks
`of conjunctival injection for 3 years, and xerostoma.
`In January, 1954, examination
`revealed Sjogren's syndrome with signs of Felty's syndrome.
`When mild exacerbation of ocular symptoms occurred in February, 1954, Schirmer's
`test gave 3mm. in both eyes, and 1 per cent. cortisone eye-drops four times daily gave
`relief within 3 days; after 9 days of treatment the drops were withdrawn and relapse
`Further therapy with 1 per cent. cortisone eye-drops four times daily was
`occurred.
`then given for 3 weeks with prompt relief; since the end of course the patient has had no
`further ocular symptoms.
`Case 10, a female aged 60 years, had had severe rheumatoid arthritis for 20 years,
`and sore eyes and photophobia for 1 year, with xerostoma; KCS was diagnosed and
`Schirmer's test gave 3 mm. in the right eye and 5 mm. in the left; vision was 6/24 in the
`right eye and 6/9 in the left.
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`95
`The ocular symptoms had not been relieved by various eye-drops, but improved after
`subconjunctival injections of 0-3-ml. 2N per cent. cortisone acetate solution.
`In April, 1954, oral cortisone 50 mg. daily caused some relief of the arthritis, but there
`was an exacerbation of the ocular symptoms which was controlled by cortisone drops.
`The response to Schirmner's test remained unaltered.
`Case 11, a female aged 53 years, had had rheumatoid arthritis for 12 years, and recurrent
`ocular inflammation and corneal ulceration for 9 years.
`In May, 1954, KCS was diagnosed
`and Schirmer's test gave 2 mm. in the right eye and 11 mm. in the left.
`Vision was 6/5
`in the right eye and 6/6 in the'left.
`Corneal scarring was seen in the left eye.
`Treatment
`was begun with hydrocortisone eye-drops 0-625 per cent. four times daily to the left eye
`and cortisone eye-drops four times daily to the right eye.
`After 2 weeks, subjective
`improvement occurred in both eyes, but the ophthalmic appearance were unchanged.
`Schirmer's test gave zero results in both eyes.
`Case 12, a female aged 53 years, had had rheumatoid arthritis for 18 years, and recurrent
`sore eyes and xerostoma for 6 months.
`In November, 1953, KCS was diagnosed and
`Schirmer's test gave 8 mm. in the right eye and 4 mm. in the left.
`Vision was 6/6 part
`in both eyes.
`Cortisone drops were given 3-hourly for 2 days, and then three times daily
`in both eyes; after 1 week there was considerably subjective improvement, but the vision
`was unaltered and Schirmer's test still gave 2 mm. in the right eye and 1 mm. in the left.
`
`Results of Treatment
`(a) Topical Therapy.-Cortisone eye-drops were used in the treatment of
`twelve patients, of whom eight obtained definite and marked relief of symp-
`toms, three obtained partial relief when the drops were instilled frequently,
`and one derived no benefit. When cortisone eye-drops were effective, the
`benefit was usually definite within 4 days of starting treatment.
`Cessation
`of therapy usually resulted in prompt relapse, but in two instances (Cases 2
`and 9) the patients enjoyed relatively prolonged remissions after cortisone was
`withdrawn.
`Hydrocortisone eye-drops were administered to five patients.
`In only
`one instance did the benefit obtained from hydrocortisone significantly
`exceed that derived from cortisone (Case 1). One patient found both local
`cortisone and hydrocortisone equally ineffective.
`The addition of cortisone eye ointment to local therapy in two cases gave
`no extra benefit.
`(b) Systemic Therapy.-Oral cortisone therapy was given to three patients.
`In two instances (Cases 1 and 7) it was effective in controlling symptoms, but
`in one (Case 10) 50 mg. daily did not control the ocular symptoms. One
`patient (Case 1) also had a course of ACTH with suppression of ocular
`Systemic cortisone and ACTH did not lead to any significant
`symptoms.
`increase in lacrimal secretion.
`(c) Sealing Lacrimal Puncta and Canaliculi.-This operation was carried out
`in five patients, all of whom obtained very marked relief, including one who
`had completely failed to improve (Case 4) and two patients (Cases 3 and 5)
`who had improved only slightly with cortisone eye-drops.
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`96
`
`STELLA EA DIE AND MALCOLM THOMPSON
`
`Discussion
`It has been possible to evaluate critically the results of treatment with
`Control of observations was possible by observing the
`local cortisone.
`response in one eye treated with local cortisone while the other eye remained
`untreated; and also by using interrupted courses of treatment.
`The response to local cortisone therapy (0.625 per cent. solution three times
`For the more severe cases stronger preparations
`daily) was generally good.
`were found to be more effective, and more frequent instillation was required.
`Hydrocortisone eye-drops did not appear to be any more effective than
`cortisone, although hydrocortisone is usually considered to be more active
`The addition of cortisone eye ointment to local therapy did not
`locally.
`augment the therapeutic response.
`Cortisone and hydrocortisone are presumably effective in local treatment
`by virtue of their direct anti-inflammatory action on the corneal and con-
`Amelioration of symptoms and improvement of vision
`junctival tissues.
`corresponded with reduction of vascular hyperemia and mucoid exudate.
`There was usually a definite decrease in the corneal filaments and staining
`Topical therapy
`reaction, but this latter finding was not invariably the rule.
`did not lead to any increased lacrimal secretion as measured by Schirmer's
`test.
`Five patients, three of whom had obtained only slight benefit from the use
`of cortisone, all received marked benefit from the sealing of the lacrimal
`Increase in the values given by Schirmer's test was sometimes
`puncta.
`noted, but was not so striking as in the cases recorded by Holm (1949).
`It is considered that although sealing the lacrimal puncta is the most effective
`treatment of severe kerato-conjunctivitis sicca, it may give rise to troublesome
`epiphora and should therefore be reserved for the more severe or persistent
`cases who either show an inadequate response to local cortisone therapy or
`who require prolonged treatment.
`
`Summary
`Twelve cases of kerato-conjunctivitis sicca are described.
`Cortisone
`Hydrocortisone
`eye-drops satisfactorily relieved symptoms in most cases.
`drops did not appear to be more effective, nor did the addition of cortisone
`Systemic cortisone and ACTH
`eye ointment confer any extra benefit.
`therapy were effective, but their use is not warranted in the treatment of this
`condition.
`Sealing the lacrimal canaliculi relieved the more severe cases, and this
`form of treatment is most valuable in patients who require prolonged topical
`cortisone or whose response is inadequate.
`We gratefully acknowledge the invaluable advice and co-operation of Dr. G.- I. Scott of
`Edinburgh Royal Infirmary, and Dr. J. J. R. Duthie of the Northern General Hospital, Edinburgh.
`During the period when this work was undertaken, the Rheumatic Unit, Northern General
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`Hospital, was in receipt of grants from the Nuffield Foundation and Medical Research Council,
`and one of us (S. E.) received a grant from the W. H. Ross Foundation (Scotland) for the
`Prevention of Blindness.
`The cortisone and ACTH used in the treatment of several of these patients was supplied by
`the Medical Research Council, to whom we are indebted.
`
`REFERENCES
`BEIGLBOCK, W., and HOFF, H. (1952).
`Dtsch. med. Wschr., 77, 7, 42.
`BOURNE, L. B. (1952).
`Brit. med. J., 2, 446.
`CADMAN, E. F. B., and ROBERTSON, A. J. (1952).
`Ibid., 2, 68.
`CIUSTINI, G. (1952).
`Riv. Oto-neuro-oftal., 27, 59.
`DUKE-ELDER, S. (1951).
`British Journal of Ophthalmology, 35, 666.
`FERNANDEZ Y FERNANDES, M., and MARAN6N, G. (1952).
`Bol. Inst. Patol. med. (Madr.), 7, 6
`Abs. in Ophthal. Lit. (Lond.) (1953).
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`FITZGERALD, J. R., BELLOWS, J. G., DONEGAN, J. M., GAMBLE, R. C., KRAUSE, A. C., MANN, W. A.,
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`PEARLMAN, M. D., and ZEKMAN, J. N. (1951).
`FORESTIER, J., CERTONCINY, A., JACQUELINE, F., and SAINT-MARC, J. (1951).
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`FRENKEL, M., HELLINGA, G., and GROEN, J. (1951).
`Acta. endocrinol. (Kbh.), 6, 161.
`HOLM, S. (1949).
`Acta ophthal. (Kbh.), Suppl. 33.
`OFFRET, G., and FOREST, ?. (1950).
`Bull. Soc. Ophtal. France., No. 9, p. 759
`(1951).
`Ibid., No. 1, p. 20.
`Quoted by DUKE-ELDER (1951).
`PHILLIPS, C. (1952).
`Arch. Ophthal. (Chicago), 48, 518.
`SJOGREN, H., and ERIKSEN, A. (1952).
`Acta ophthal. (Kbh.), 30, 463.
`STEPHENS, C. A. L. (1950).
`" Proceedings First Clinical ACTH Conference ", ed. J. R. Mote,
`Churchill, London.
`p. 358.
`
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`Kerato-Conjunctivitis
`Sicca treated with
`Cortisone and ACTH
`Stella Eadie and Malcolm Thompson
`
`Br J Ophthalmol 
`1955 39: 90-97
`doi: 10.1136/bjo.39.2.90
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